Data / Medical devices / United States / Ethicon Endo-Surgery, Inc.

Ethicon Endo-Surgery, Inc.: FDA-registered device maker in Cincinnati, OH, United States, 77 510(k) clearances

Name: Ethicon Endo-Surgery, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ethicon Endo-Surgery, Inc. is registered with the FDA (registration 1527736) in Cincinnati, OH, United States. It lists 20 device types. The FDA files 77 510(k) clearances under its listings, the newest dated May 11, 2026. 47 recall events name it as the recalling firm (5 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Ethicon Endo-Surgery, Inc.

FDA registration number: 1527736
Address: 4545 Creek RD., Cincinnati, OH, United States, 45242
Owner or operator: ETHICON ENDO-SURGERY, INC. (9010225)
Roles: Specification developer
First device listed: August 20, 1997
Registered through: 2026
Brand names listed: 12-L 12MM Endoscopic ROTATING MULTIPLE CLIP APLLIER, ADVANT, BASX, CONTOUR, DUALTO Energy System, ECHELON, ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler, ECHELON 3D Reload and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Exhaust, Surgical	FYD	2	Specification developer	accessdata.fda.gov
Apparatus, Pneumoperitoneum, Automatic	FDP	2	Specification developer	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	1	Specification developer	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Specification developer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Specification developer	accessdata.fda.gov
Clip, Implantable	FZP	2	Specification developer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Specification developer	accessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)	HGI	2	Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Specification developer	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Specification developer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Specification developer	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Specification developer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Specification developer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Specification developer	accessdata.fda.gov
Laparoscopic Accessories, Esophageal Sizing	QJN	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Absorbable, Staple Line Reinforcement	OXC	2	Specification developer	accessdata.fda.gov
Staple, Implantable	GDW	2	Specification developer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Specification developer	accessdata.fda.gov
Stapler, Surgical	GAG	2	Specification developer	accessdata.fda.gov
Tray, Surgical	LRP	1	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 11, 2026	K260196	ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
January 9, 2026	K252906	ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)	OXC	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
December 17, 2025	K252739	ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
May 14, 2025	K250835	ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
January 17, 2025	K243067	The ETHICON Total Energy System	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)	accessdata.fda.gov
October 28, 2024	K241630	ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
August 29, 2023	K232313	LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)	FZP	Substantially Equivalent	Ethicon Endo Surgery, LLC	accessdata.fda.gov
April 13, 2023	K230387	ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
March 15, 2023	K223760	ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G)	GDW	Substantially Equivalent	Ethicon Endo-Surgery	accessdata.fda.gov
February 28, 2023	K221790	HARMONIC 700 Shears	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
April 8, 2022	K213633	ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler	GAG	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
May 21, 2021	K211273	Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
January 22, 2021	K201696	ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
January 22, 2021	K201066	ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
October 15, 2020	K202665	Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
July 27, 2020	K201280	Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
July 9, 2020	K201035	ETHICON Linx Esophagus Sizing Tool	QJN	Substantially Equivalent	Torax Medical, Inc.	accessdata.fda.gov
June 29, 2020	K200420	Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
June 26, 2020	K200250	Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor	FYD	Substantially Equivalent	Megadyne Medical Products, Inc.	accessdata.fda.gov
May 11, 2020	K200841	Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
February 28, 2020	K191555	HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
October 14, 2019	K190937	Echelon Endopath Staple Line Reinforcement	OXC	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
February 6, 2019	K183435	Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
October 30, 2018	K181488	LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier	FZP	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
May 23, 2018	K180403	ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
May 7, 2018	K180031	Endopath Electrosurgery Probe Plus II	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
November 20, 2017	K172580	ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
April 18, 2017	K163523	ECHELON CIRCULAR Powered Stapler	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
February 14, 2017	K163548	ENSEAL X1 Large Jaw Tissue Sealer	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
January 5, 2017	K163454	ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
September 9, 2016	K160554	Enseal X1 Large Jaw Tissue Sealer	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
April 28, 2016	K160128	Endopath Electrosurgery Probe Plus II	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
September 10, 2015	K150840	Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier	FZP	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
July 10, 2015	K151340	HARMONIC Focus Long Shears + Adaptive Tissue Technology	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
May 18, 2015	K150026	Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
November 24, 2014	K141952	ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED	GDW	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
April 22, 2014	K140560	ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
December 16, 2013	K132522	HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
December 3, 2013	K133314	HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
October 17, 2013	K132612	HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
October 3, 2013	K131435	ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
March 29, 2013	K130653	ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
January 25, 2013	K122797	ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW	GEI	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
October 1, 2012	K122511	ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
August 22, 2012	K121550	HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
July 16, 2012	K121600	ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
March 25, 2011	K110699	LIGAMAX 5	FZP	Substantially Equivalent	Ethicon Endo-Sugery, LLC	accessdata.fda.gov
September 15, 2009	K092577	ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
June 1, 2009	K091322	CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G	GDW	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
June 26, 2008	K081146	ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
May 21, 2008	K080839	ECHELON GRAY CARTRIDGE, MODEL ERC45M	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
June 13, 2007	K070198	ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
May 25, 2007	K070887	ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)	GDW	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
January 30, 2007	K063192	HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP	LFL	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
October 10, 2006	K062209	BASX BLADELESS TROCAR	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
April 7, 2006	K060245	HARMONIC SCALPEL BLADES AND SHEARS	LFL	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
October 30, 2003	K032676	ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
June 5, 2002	K020779	PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS	GDW	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
October 1, 2001	K012176	ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145	LFL	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
July 19, 2001	K011501	ENDOPOUCH RETRIEVER	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
December 15, 2000	K002906	ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07	LFL	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
September 17, 1999	K990362	INSTRUMENT, ULTRASONIC, SCALPEL	GEI	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
June 22, 1999	K984240	ENDOPATH ENDOSCOPIC INSTRUMENTS	GEI	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
February 3, 1999	K983925	ENDOPATH ULTRA VERESS NEEDLE	HIF	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
December 18, 1998	K983536	PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS	GDW	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
October 1, 1997	K972578	ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
September 19, 1997	K972679	ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
January 8, 1997	K963760	NON-SHIELDED SURGICAL TROCAR AND SLEEVE	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
November 4, 1996	K962584	ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE	LFL	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
May 27, 1994	K940967	MODIFIED ENDOPATH ILS	OCW	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
June 22, 1993	K931111	ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, Inc.	accessdata.fda.gov
April 2, 1992	K920110	ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE	GEA	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
March 19, 1991	K910875	ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE	FDP	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
January 25, 1991	K904993	LAPAROSCOPIC ELECTROSURGICAL DEVICE	GEI	Substantially Equivalent	Everest Medical Corp.	accessdata.fda.gov
November 5, 1986	K864102	LIGACLIP 20/20* MULTIPLE CLIP APPLIER	FZP	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
March 8, 1983	K830503	LIGACLIP TITANIUM LIGATING CLIP	FZP	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
May 28, 1982	K820837	DISPOSABLE MULTIPLE LIGATING CLIP	GDO	Substantially Equivalent	ETHICON, 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
September 11, 2025	97654	Class II	Ongoing	ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80	The devices were shipped unsterilized.	accessdata.fda.gov
April 22, 2025	96750	Class I	Ongoing	Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35	Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potent	accessdata.fda.gov
December 11, 2023	93735	Class II	Ongoing	ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W	There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.	accessdata.fda.gov
July 20, 2021	88434	Class II	Ongoing	HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20	An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns	accessdata.fda.gov
June 3, 2021	88349	Class II	Terminated	ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and	Mislabeled: Labeled on the package as 60mm contains 45mm devices	accessdata.fda.gov
November 7, 2019	84280	Class II	Terminated	Ligamax 5 mm Endoscopic Multiple Clip Applier	A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.	accessdata.fda.gov
October 3, 2019	83897	Class I	Terminated	ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A	The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervent	accessdata.fda.gov
May 15, 2019	82973	Class II	Terminated	Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C	Observed reported incidence rate for harm associated with intraoperative bleeding	accessdata.fda.gov
April 11, 2019	82539	Class I	Completed	Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the	The staplers may have an insufficient firing stroke to break the washer and completely form staples.	accessdata.fda.gov
December 7, 2018	81773	Class II	Terminated	PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of	Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired	accessdata.fda.gov
May 3, 2018	80066	Class II	Terminated	HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE Shears + Adaptive Tissue Technology are indicated for soft ti	The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.	accessdata.fda.gov
March 26, 2018	79801	Class II	Terminated	5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT	Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.	accessdata.fda.gov
October 23, 2017	79246	Class II	Terminated	Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.	There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.	accessdata.fda.gov
March 31, 2017	76921	Class II	Terminated	Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM	There is a risk that the pinion gear in the device could fail under extreme use cases.	accessdata.fda.gov
July 15, 2016	74701	Class II	Terminated	Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection	Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the	accessdata.fda.gov
September 23, 2015	72285	Class II	Terminated	HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.	Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.	accessdata.fda.gov
May 13, 2015	71551	Class I	Terminated	SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/m	Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.	accessdata.fda.gov
February 26, 2015	71215	Class II	Terminated	ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical p	During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.	accessdata.fda.gov
August 12, 2014	69109	Class II	Terminated	PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Ste	The device may have a non-conforming component that may cause the device to fire an unformed staple.	accessdata.fda.gov
September 30, 2013	66465	Class II	Terminated	Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbi	During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.	accessdata.fda.gov
May 13, 2013	65330	Class II	Terminated	ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use	Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.	accessdata.fda.gov
April 12, 2013	65141	Class II	Terminated	LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligati	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure	accessdata.fda.gov
April 8, 2013	65504	Class II	Terminated	Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula	The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.	accessdata.fda.gov
November 6, 2012	64055	Class II	Terminated	Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C4	Potential for self activation while the device is in use, which may result in unintended thermal damage.	accessdata.fda.gov
October 4, 2012	64343	Class II	Terminated	PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.	Damage to the packaging may have compromised the sterility of the device.	accessdata.fda.gov
August 3, 2012	62879	Class I	Terminated	Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall def	Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.	accessdata.fda.gov
March 16, 2012	61540	Not yet classified	Terminated	HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo	Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMONIC Generator 300 (GEN04). The problem occurs after successful set up and initial use of HARMONIC Hand Pieces (HP054 and HPBLUE) with the Generator 300 (GEN04).	accessdata.fda.gov
March 2, 2012	61750	Not yet classified	Terminated	The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that del	There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing release lever.	accessdata.fda.gov
January 26, 2012	61314	Not yet classified	Terminated	ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Curved Jaw, Model # NSLG2C25. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 T	Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycl	accessdata.fda.gov
July 29, 2011	59764	Not yet classified	Terminated	ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 The ETS Compact-Flex45 Articulating L	Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.	accessdata.fda.gov
September 27, 2010	56939	Not yet classified	Terminated	ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'	This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially can lead to loss of pneumoperitoneum during a surgical procedure. Pneumoperitoneum leaks may lead to conversion from laparoscopic to open surgery.	accessdata.fda.gov
September 27, 2010	56938	Not yet classified	Terminated	REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3, ZJBBBG, ZJBBBH, ZJ	The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abd	accessdata.fda.gov
July 9, 2010	56292	Not yet classified	Terminated	Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05	The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods qualit	accessdata.fda.gov
March 27, 2009	57580	Not yet classified	Terminated	ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses.	The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.	accessdata.fda.gov
January 13, 2009	56940	Not yet classified	Terminated	ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969.	The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue, there is a risk the surgery will need to be modified to remove the device. This may lead to an increase in procedure time,	accessdata.fda.gov
December 9, 2008	50510	Not yet classified	Terminated	Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product Code EPS01)	Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a react	accessdata.fda.gov
April 24, 2008	48604	Not yet classified	Terminated	ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.	The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.	accessdata.fda.gov
November 6, 2007	45869	Not yet classified	Terminated	Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242	Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.	accessdata.fda.gov
April 2, 2007	37872	Not yet classified	Terminated	Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope.	The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some surgeons as a completed firing cycle, which may cause the surgeon to prematurely stop firing the device and result in incomp	accessdata.fda.gov
April 20, 2006	35228	Not yet classified	Terminated	Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length, hollow tip electrdode, Product Code EPS01.	There is the possibility of a seal void in the Probe Plus packaging which may compromised the sterility of the device.	accessdata.fda.gov
February 28, 2005	31351	Not yet classified	Terminated	ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100. Ten cartridges are packaged per box.	The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.	accessdata.fda.gov
December 15, 2004	30727	Not yet classified	Terminated	Endopath 5 mm Graspers with Ratchet Handles (product code 5DSG).	Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.	accessdata.fda.gov
December 10, 2004	30718	Not yet classified	Terminated	Mammotome EX Holster	A capacitor of the wrong value was used. The capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications.	accessdata.fda.gov
November 21, 2004	30516	Not yet classified	Terminated	Endopath EZ45 Endoscopic Linear Cutter (EZ45B)	The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.	accessdata.fda.gov
June 7, 2004	29269	Not yet classified	Terminated	LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers.	This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.	accessdata.fda.gov
November 25, 2003	27763	Not yet classified	Terminated	Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.	A defective articulation band may result in improper staple formation with possible hematosis.	accessdata.fda.gov
May 21, 2003	26386	Not yet classified	Terminated	Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.	The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.	accessdata.fda.gov

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Updated May 11, 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.