Data / Medical devices / United States / Stryker Endoscopy

Stryker Endoscopy: FDA-registered device maker in San Jose, CA, United States, 170 510(k) clearances

Name: Stryker Endoscopy FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Stryker Endoscopy is registered with the FDA (registration 2936485) in San Jose, CA, United States. It lists 110 device types. The FDA files 170 510(k) clearances under its listings, the newest dated July 17, 2026. 64 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Stryker Endoscopy

FDA registration number: 2936485
Address: 5900 Optical Ct, San Jose, CA, United States, 95138
Owner or operator: STRYKER CORP. (1811755)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 29, 1977
Registered through: 2027
Brand names listed: 01030100 HipCheck, 01030300 HipCheck Software, 0203-1000 SportsSuite Vision Software, 0220-240-300 L12 LED Light Source with Advanced Imaging Modality, 0220240300 PKG, L12 LED LIGHT SOURCE WITH AIM, 0240200100 0240200200 Connected OR Hub Device Management System 1, 0240200100 Connected OR Hub Device Management System, 0240200101 Connected OR Hub VIP Package and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Manufacturer	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Manufacturer, Specification developer	accessdata.fda.gov
Arthroscope	HRX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System	SIT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Manufacturer, Specification developer	accessdata.fda.gov
Basic Set-Up Tray	PXN	1	Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Bit, Surgical	GFG	1	Manufacturer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Specification developer	accessdata.fda.gov
Blade, Scalpel	GES	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Manufacturer, Specification developer	accessdata.fda.gov
Camera, Still, Endoscopic	FXM	1	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Specification developer	accessdata.fda.gov
Camera, Television, Surgical, Without Audio	FWB	1	Manufacturer	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Specification developer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	KNF	2	Specification developer	accessdata.fda.gov
Confocal Optical Imaging	OWN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Cover, Barrier, Protective	MMP	2	Complaint file establishment	accessdata.fda.gov
Curette	HTF	1	Specification developer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Specification developer	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Device, Digital Image Storage, Radiological	LMB	1	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Flexible	FGO	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Repackager or relabeler	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Manufacturer	accessdata.fda.gov
Electrode, Electrosurgical, Active, Urological	FAS	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer, Specification developer	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Endoscope, Neurological	GWG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Specification developer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	2	Specification developer	accessdata.fda.gov
Endoscopic Magnetic Retriever, Exempt	PTQ	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Specification developer	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Specification developer	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Manufacturer, Specification developer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer, Specification developer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Specification developer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Specification developer	accessdata.fda.gov
General Surgery Tray	LRO	2	Specification developer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Hemostat	HRQ	1	Manufacturer, Specification developer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Specification developer	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Image, Illumination, Fiberoptic, For Endoscope	FFS	2	Specification developer	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Specification developer	accessdata.fda.gov
Insufflator, Endoscopic Vessel Harvesting	OSV	2	Specification developer	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Specification developer	accessdata.fda.gov
Irrigator, Powered Nasal	KMA	1	Complaint file establishment	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Specification developer	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Manufacturer, Specification developer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Manufacturer, Specification developer	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Light, Catheter, Fiberoptic, Glass, Ureteral	FCS	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Light, Surgical Headlight	EBA	1	Manufacturer	accessdata.fda.gov
Light, Surgical, Carrier	FSZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Light, Surgical, Floor Standing	FSS	2	Manufacturer	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Complaint file establishment	accessdata.fda.gov
Microscope, Surgical	EPT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Passer	HWQ	1	Specification developer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Specification developer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Specification developer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Specification developer	accessdata.fda.gov
Resectoscope, Working Element	FDC	2	Specification developer	accessdata.fda.gov
Retractor	GAD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen	OLC	2	Complaint file establishment	accessdata.fda.gov
Scissors, Orthopedic, Surgical	HRR	1	Manufacturer, Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Screwdriver	HXX	1	Specification developer	accessdata.fda.gov
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed	QPQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Complaint file establishment	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Manufacturer, Specification developer	accessdata.fda.gov
Starter, Bone Screw	HWD	1	Specification developer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Stripper, Surgical	HRT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Specification developer	accessdata.fda.gov
System, Surgical, Computer Controlled Instrument	NAY	2	Complaint file establishment	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Repackager or relabeler	accessdata.fda.gov
Table, Operating-Room, Ac-Powered	FQO	1	Complaint file establishment	accessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Manual	JEB	1	Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Specification developer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Tube, Smoke Removal, Endoscopic	FCZ	1	Specification developer	accessdata.fda.gov
Tubing And Tubing/Filter Fits	NVT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Specification developer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Manufacturer, Specification developer	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Warmer, Thermal, Infusion Fluid	LGZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 170.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 17, 2026	DEN250040	SportSuite Vision Software	SIT	Unknown	Stryker Endoscopy	accessdata.fda.gov
June 4, 2026	K253602	Precision S 4K Sinuscope	GWG	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
May 28, 2026	K261037	780 nm SPY Portable Handheld Imaging (SPY-PHI) System	IZI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
February 18, 2026	K260185	1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
February 12, 2026	K260108	L12 LED Light Source with AIM	OWN	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
January 13, 2026	K254014	Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
December 31, 2025	K253888	MOLLI 2 System	NEU	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
July 18, 2025	K252012	SPY Cystoscope/Hysteroscope	HIH	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
May 23, 2025	K250544	Knotilus+ Biocomposite Knotless Anchor	MAI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
May 21, 2025	K250528	Stryker AlphaVent Knotless SP Biocomposite Anchor	MAI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
September 26, 2024	K234149	MOLLI 2 System	NEU	Substantially Equivalent	Molli Surgical, Inc.	accessdata.fda.gov
September 25, 2024	K240042	MOLLI 2 System	NEU	Substantially Equivalent	Molli Surgical, Inc.	accessdata.fda.gov
August 15, 2024	K241401	Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
February 22, 2024	K240174	1688 4K Camera System with Advanced Imaging Modality	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
February 12, 2024	K233635	SPY Cystoscope/Hysteroscope	HIH	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
January 25, 2024	K233893	AlphaVent Knotless SP PEEK Anchor	MBI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
January 9, 2024	K233327	1788 4K Camera System with Advanced Imaging Modality	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
October 26, 2023	K231579	MOLLI 2	NEU	Substantially Equivalent	Molli Surgical, Inc.	accessdata.fda.gov
October 24, 2023	K232683	Knotilus+ PEEK Knotless Anchor	MBI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
September 29, 2023	K230045	HipCheck	QIH	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
September 20, 2023	K231854	1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM	OWN	Substantially Equivalent	Stryker	accessdata.fda.gov
August 30, 2023	K231093	AlphaVent Suture Anchors	MBI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
August 18, 2023	K232157	Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control	GCJ	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
June 21, 2023	K230886	Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
April 11, 2023	K230754	L12 LED Light Source with AIM	OWN	Substantially Equivalent	Stryker	accessdata.fda.gov
March 31, 2023	K230605	1788 4K Camera System with Advanced Imaging Modality	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
February 23, 2023	K230216	1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
January 18, 2023	K223107	MOLLI 2	NEU	Substantially Equivalent	Molli Surgical, Inc.	accessdata.fda.gov
October 11, 2022	K222079	Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
August 19, 2022	K222130	1688 4K Camera System with Advanced Imaging Modality	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
June 17, 2022	K221217	SPY Laparoscope	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
April 22, 2022	K220895	1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
February 9, 2022	K220108	SDC4K Information Management System with Device and Voice Control Package	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
December 16, 2021	K212055	Connected OR Hub with Device and Voice Control	GCJ	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
November 4, 2021	K212511	1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
November 4, 2021	K210628	X-FLO Fluid Management System	HIG	Substantially Equivalent	Thermedx, LLC	accessdata.fda.gov
August 6, 2021	K211202	1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes	GWG	Substantially Equivalent	Stryker	accessdata.fda.gov
July 12, 2021	DEN200039	InSpace Subacromial Tissue Spacer System	QPQ	Unknown	Ortho-Space , Ltd.	accessdata.fda.gov
April 13, 2021	K210088	1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
March 18, 2021	K210584	SDC3 HD Information Management System with Wireless Device Control Capability	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
March 11, 2021	K210078	Stryker ProCinch Adjustable Loop Device	MBI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
December 1, 2020	K202659	Stryker Arthroscope	HRX	Substantially Equivalent	Stryker	accessdata.fda.gov
November 13, 2020	K202355	Stryker Omega PEEK Knotless Anchor System	MBI	Substantially Equivalent	Stryker	accessdata.fda.gov
November 5, 2020	K202244	SPY-PHI System with SPY-PHI Fluorescence Assessment Software	OWN	Substantially Equivalent	Novadaq Technologies Ulc. (Now A Part of Stryker)	accessdata.fda.gov
October 8, 2020	K202592	Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
July 29, 2020	K201361	PNEUMOCLEAR	HIF	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
July 28, 2020	K201434	Connected OR Hub with Voice Control, Connected OR Hub with Device Control	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
May 21, 2020	K200737	SPY Portable Handheld Imaging (SPY-PHI) System	OWN	Substantially Equivalent	Novadaq Technologies Ulc. (Now A Part of Stryker)	accessdata.fda.gov
March 6, 2020	K200310	1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
November 19, 2019	K192292	L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable	OWN	Substantially Equivalent	Stryker	accessdata.fda.gov
September 9, 2019	K192172	Connected OR Hub with Device and Voice Control	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
September 6, 2019	K191102	Precision S 4K Sinuscope	EOB	Substantially Equivalent	Stryker	accessdata.fda.gov
July 12, 2019	K191259	Stryker CrossFlow Integrated Arthroscopy Pump	HRX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
May 10, 2019	K191046	L10 LED Light Source with AIM, L11 LED Light Source with AIM	OWN	Substantially Equivalent	Stryker	accessdata.fda.gov
April 19, 2019	K190729	SPY Portable Handheld Imaging (SPY-PHI) System	OWN	Unknown	Novadaq Technologies Ulc. (Now A Part of Stryker)	accessdata.fda.gov
January 7, 2019	K183470	Precision Ideal Eyes Arthroscopes	HRX	Substantially Equivalent	Stryker	accessdata.fda.gov
December 13, 2018	K182359	HipCheck	LLZ	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
November 21, 2018	K182606	PINPOINT Endoscopic Fluorescence Imaging System	GCJ	Substantially Equivalent	Novadaq Technologies Ulc. (Now A Part of Stryker)	accessdata.fda.gov
November 5, 2018	K182160	1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
November 5, 2018	K181258	ConnectedOR Hub with Device and Voice Control	GCJ	Substantially Equivalent	Stryker	accessdata.fda.gov
September 21, 2018	K171947	SOLOASSIST II	NAY	Substantially Equivalent	Aktormed GmbH	accessdata.fda.gov
July 23, 2018	K181083	Stryker All-PEEK Knotless Anchor System	MBI	Substantially Equivalent	Stryker	accessdata.fda.gov
April 4, 2018	K173074	ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor	MBI	Substantially Equivalent	Stryker	accessdata.fda.gov
January 26, 2018	K171391	Stryker 90-S Max SERFAS Energy Probe	GEI	Substantially Equivalent	Stryker	accessdata.fda.gov
September 5, 2017	K172048	FluidSmart	HIG	Substantially Equivalent	Thermedx, LLC	accessdata.fda.gov
May 15, 2017	K170784	PNEUMOCLEAR	HIF	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
May 2, 2017	K170364	Collagen Meniscus Implant XL	OLC	Substantially Equivalent	Ivy Sports Medicine, LLC	accessdata.fda.gov
July 14, 2016	K153087	IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved	GAT	Substantially Equivalent	Ivy Sports Medicine, LLC	accessdata.fda.gov
May 18, 2016	K160332	Stryker SDC3 HD Information Management System with Wireless Device Control Capability	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
May 3, 2016	K160050	SERFAS 90-S Electrosurgical Probe	GEI	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
March 31, 2016	K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing	HRX	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
December 28, 2015	K152951	Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray	KCT	Substantially Equivalent	Paragon Medical, Inc.	accessdata.fda.gov
August 20, 2015	K151243	STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]	FCS	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
July 23, 2015	K151314	CinchLock Flex Knotless Suture Anchor	MBI	Substantially Equivalent	Pivot Medical	accessdata.fda.gov
April 17, 2015	K150416	ProCinch Adjustable Loop Device	HTY	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
February 4, 2015	K150127	Laparoscopic Handles with peek Insulation	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
December 2, 2014	K142310	Stryker Infrared Fluorescence (IRF) Imaging System	OWN	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
October 23, 2014	K142603	Stryker Precision HD Camera System	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
February 28, 2014	K133671	ICONIX ALL SUTURE ANCHORS	MBI	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
December 16, 2013	K132785	STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
October 7, 2013	K131769	CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM	MBI	Substantially Equivalent	Pivot Medical, Inc.	accessdata.fda.gov
April 12, 2013	K130929	ZMED VP4000	LLZ	Substantially Equivalent	Zmed, Inc.	accessdata.fda.gov
January 9, 2013	K123441	STRYKER CROSSFLOW ARTHROSCOPY PUMP	HRX	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
September 12, 2012	K121112	STRYKER VIDEO URETEROSCOPE	FGB	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
September 5, 2012	K121893	STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
July 26, 2012	K120509	STRYKER ALL SUTURE ANCHORS	MBI	Substantially Equivalent	Stryker	accessdata.fda.gov
July 18, 2012	K120824	3.9MM REELX STT SUTURE ANCHOR SYSTEM	MBI	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
June 3, 2012	K113597	MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES	GEI	Substantially Equivalent	Minilap Technologies	accessdata.fda.gov
August 9, 2010	K100887	VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY	KCT	Substantially Equivalent	Tag Medical Products	accessdata.fda.gov
March 5, 2010	K093677	STRYKER ARTHROSCOPE	HRX	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
November 20, 2009	K083754	MINI LAP ELECTROCAUTERY INSTRUMENTS	GEI	Substantially Equivalent	Mini Lap Technologies, Inc.	accessdata.fda.gov
May 20, 2009	K090530	SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01	MBI	Substantially Equivalent	Ross Creek Medical, Inc.	accessdata.fda.gov
April 22, 2009	K090070	INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM	FST	Substantially Equivalent	Invuity, Inc.	accessdata.fda.gov
December 19, 2008	K082813	STRYKER LED LIGHTSOURCE	FCW	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
December 18, 2008	K082079	REGEN COLLAGEN SCAFFOLD (CS)	OLC	Substantially Equivalent	Regen Biologics, Inc.	accessdata.fda.gov
December 16, 2008	K082451	STRYKER VIDEOSCOPE	HET	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
October 2, 2008	K081995	STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
May 29, 2008	K080161	PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR	GCJ	Substantially Equivalent	Patton Surgical Corp.	accessdata.fda.gov
December 18, 2007	K072180	VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM	FAJ	Substantially Equivalent	Vision-Sciences, Inc.	accessdata.fda.gov
November 16, 2007	K071127	FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM	HIH	Substantially Equivalent	Vision-Sciences, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 8, 2026	99340	Class II	Ongoing	STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600	There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.	accessdata.fda.gov
April 9, 2026	98696	Class II	Ongoing	Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming	Due to nonconforming products being inadvertently distributed.	accessdata.fda.gov
January 21, 2026	98295	Class II	Ongoing	MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 008500241951	Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.	accessdata.fda.gov
June 18, 2025	97039	Class II	Ongoing	Stryker, StrykeFlow, REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip	Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.	accessdata.fda.gov
January 29, 2025	96281	Class II	Ongoing	Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197	Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.	accessdata.fda.gov
September 13, 2023	93140	Class II	Ongoing	Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.	Expired product distributed	accessdata.fda.gov
August 23, 2023	92955	Class II	Ongoing	Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462	Expired Product distributed	accessdata.fda.gov
March 2, 2023	91891	Class II	Ongoing	SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200	Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.	accessdata.fda.gov
January 14, 2022	89515	Class II	Ongoing	1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.	A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.	accessdata.fda.gov
February 26, 2021	87540	Class II	Terminated	Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging	Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.	accessdata.fda.gov
January 7, 2020	85474	Class II	Ongoing	Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282	Sterile drapes packaged in an unsealed pouch.	accessdata.fda.gov
September 12, 2019	85100	Class II	Terminated	Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFl	Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is	accessdata.fda.gov
July 19, 2019	84664	Class II	Terminated	Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197	Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.	accessdata.fda.gov
April 23, 2019	84715	Class II	Terminated	Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grad	There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monitor arm and a risk of user injury.	accessdata.fda.gov
March 7, 2019	82489	Class II	Terminated	Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.	The heated tube sets were consistently leaking and detaching from the cassette.	accessdata.fda.gov
January 25, 2018	79030	Class II	Ongoing	CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I	The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.	accessdata.fda.gov
December 21, 2017	79978	Class II	Completed	3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.	Inadvertent shipment of expired units.	accessdata.fda.gov
November 17, 2017	78668	Class II	Terminated	StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Mod	Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.	accessdata.fda.gov
May 4, 2016	74070	Class II	Terminated	Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.	Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction	accessdata.fda.gov
April 12, 2016	73846	Class II	Terminated	CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices inte	Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.	accessdata.fda.gov
March 28, 2016	73674	Class II	Terminated	PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602,	When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.	accessdata.fda.gov
June 3, 2015	71385	Class II	Terminated	SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection,	Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.	accessdata.fda.gov
November 17, 2014	69838	Class II	Terminated	PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Gu	The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods	accessdata.fda.gov
June 20, 2014	68624	Class II	Terminated	Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspirati	Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.	accessdata.fda.gov
May 19, 2014	68405	Class II	Terminated	Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.	STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.	accessdata.fda.gov
April 16, 2014	68045	Class II	Terminated	12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrumen	Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.	accessdata.fda.gov
August 30, 2013	66211	Class II	Terminated	Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision M	When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.	accessdata.fda.gov
March 27, 2013	64682	Class II	Terminated	Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.	The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C, instead of the correct 132-133C.	accessdata.fda.gov
March 5, 2013	69726	Class II	Terminated	1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications	In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period	accessdata.fda.gov
June 19, 2012	62346	Class II	Terminated	Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is us	The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.	accessdata.fda.gov
May 21, 2012	61955	Class II	Terminated	Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasio	Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.	accessdata.fda.gov
October 24, 2011	60301	Not yet classified	Terminated	Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300	An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.	accessdata.fda.gov
June 8, 2011	59072	Not yet classified	Terminated	45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138 Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holdin	During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic Instruments Tray.	accessdata.fda.gov
March 7, 2011	58143	Not yet classified	Terminated	Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 The inflow/outflow cannula is intended as a general purpose, concomitant suction and irrigation device for use in e	Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual.	accessdata.fda.gov
September 29, 2010	56871	Not yet classified	Terminated	InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended use:Medical device for human use, during surgical procedures	Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.	accessdata.fda.gov
June 28, 2010	56321	Not yet classified	Terminated	Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose Medical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist and hip. The	RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.	accessdata.fda.gov
June 21, 2010	56110	Not yet classified	Terminated	Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA.	Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.	accessdata.fda.gov
May 11, 2010	56357	Not yet classified	Terminated	Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560	The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.	accessdata.fda.gov
April 16, 2010	56356	Not yet classified	Terminated	Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072. 240-099-001, 240-099-001K, 240-099-011, 240-099-011	The electrical cord power plug design may allow the prongs to develop a fracture inside or outside the plug, if the plug is misused.	accessdata.fda.gov
February 25, 2010	55617	Not yet classified	Terminated	Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.	The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).	accessdata.fda.gov
December 11, 2009	54651	Not yet classified	Terminated	Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.	Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start from 1 Oct 2001 and begin incrementing from that point onwards. The system date will be incorrect and users will not be able to correct this issue. Problem will not affect how picture	accessdata.fda.gov
November 12, 2009	54147	Not yet classified	Terminated	Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico	Potential breakage of the internal shaft of the End Cutter Shaver Blade; F-Series, 4.0mm. if breakage occurs, the device becomes non-functional and the defect could be observed through the camera/console system.	accessdata.fda.gov
October 23, 2009	54683	Not yet classified	Terminated	An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be tran	Video device is not able to assign the correct time/date stamp.	accessdata.fda.gov
August 20, 2009	53183	Not yet classified	Terminated	Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.	The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.	accessdata.fda.gov
August 20, 2009	53182	Not yet classified	Terminated	Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico	Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments.	accessdata.fda.gov
July 27, 2009	53197	Not yet classified	Terminated	Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA	Latex-- Certain lots of Product contain undeclared latex.	accessdata.fda.gov
December 29, 2008	50777	Not yet classified	Terminated	Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.	Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up at all. The risk includes delay and interruption of ongoing surgical procedures.	accessdata.fda.gov
December 1, 2008	50525	Not yet classified	Terminated	Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-65	Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.	accessdata.fda.gov
October 1, 2008	50141	Not yet classified	Terminated	Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.	Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.	accessdata.fda.gov
September 22, 2008	49549	Not yet classified	Terminated	26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization device for events occurring in the sterile field for endoscopic s	Knob parts stick together, resulting in poor functionality of the knob.	accessdata.fda.gov
June 20, 2008	50825	Not yet classified	Terminated	Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico	The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.	accessdata.fda.gov
May 9, 2008	48218	Not yet classified	Terminated	Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single	Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery	accessdata.fda.gov
March 31, 2008	47463	Not yet classified	Terminated	24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or ar	The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.	accessdata.fda.gov
February 15, 2008	46907	Not yet classified	Terminated	Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.	Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.	accessdata.fda.gov
February 7, 2008	46916	Not yet classified	Terminated	Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation to bone in certain areas.	Product package may crack and cause loss of sterility.	accessdata.fda.gov
December 7, 2007	46350	Not yet classified	Terminated	Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138	Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.	accessdata.fda.gov
November 16, 2007	45881	Not yet classified	Terminated	Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.	Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.	accessdata.fda.gov
April 26, 2007	45822	Not yet classified	Terminated	SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico	Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)	accessdata.fda.gov
June 2, 2006	35610	Not yet classified	Terminated	Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301	Device for which sterility may be compromised as evidenced by a loss of package integrity.	accessdata.fda.gov
November 18, 2005	34112	Not yet classified	Terminated	StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 9513	Devices for which sterility may be compromised as evidenced by a crack in the package.	accessdata.fda.gov
August 23, 2005	33186	Not yet classified	Terminated	Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138	The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.	accessdata.fda.gov
February 8, 2005	31145	Not yet classified	Terminated	Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138	The device has the potential to overheat and cause patient burns during use.	accessdata.fda.gov
December 27, 2004	30759	Not yet classified	Terminated	Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080	The label on the outside of the shipping box has an incorrect description of the screw diameter.	accessdata.fda.gov
November 30, 2004	30763	Not yet classified	Terminated	Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.	A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.	accessdata.fda.gov

Compare with other makers

Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.