Data / Medical devices / United States / Stryker Sustainability Solutions
Stryker Sustainability Solutions: FDA-registered device maker in Tempe, AZ, United States, 66 510(k) clearances
Stryker Sustainability Solutions is registered with the FDA (registration 3009350690) in Tempe, AZ, United States. It lists 25 device types. The FDA files 66 510(k) clearances under its listings, the newest dated June 18, 2026. 35 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009350690
- Address
- 1810 W. Drake Dr., Tempe, AZ, United States, 85283
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Reprocessor, Specification developer
- First device listed
- June 20, 2007
- Registered through
- 2027
- Brand names listed
- CABLE, ELECTRODE, Catheter, Recording, Electrode, Reprocessed, Device, Transfer, Patient Manual, Reprocessed, LXMJ23L Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider Latching Handle, Without Nano-coating 5mm - 23cm, LXMJ23S Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider One-step Sealing, Without Nano-coating 5mm - 23cm, LXMJ37L Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider Latching Handle, Without Nano-coating 5mm -, LXMJ37S Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Without Nano-coating 5mm, LXMJ44L Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider Latching Handle, Without Nano-coating 5mm - and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 18, 2026 | K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | GEI | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| August 14, 2025 | K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| October 22, 2024 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | NLF | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| July 3, 2024 | K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| February 20, 2024 | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| July 25, 2023 | K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | OWQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| March 28, 2023 | K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | GEI | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| March 28, 2023 | K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| December 4, 2022 | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | NLF | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 25, 2022 | K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | GEI | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 13, 2022 | K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 7, 2022 | K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | NUJ | Substantially Equivalent | Green Or, LLC | accessdata.fda.gov |
| March 8, 2022 | K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 | DQA | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| March 8, 2022 | K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) | NLF | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| March 16, 2021 | K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| September 25, 2020 | K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent | HIH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| July 31, 2020 | K201511 | Reprocessed Endoscopic Trocars and Sleeves | NLM | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 13, 2020 | K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | NLH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 8, 2019 | K182238 | Reprocessed ViewFlex Xtra ICE Catheter | OWQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 23, 2018 | K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 20, 2018 | K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| November 16, 2017 | K172856 | Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider | GEI | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 5, 2017 | K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| February 23, 2017 | K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| January 13, 2016 | K153415 | Reprocessed Stryker External Fixation Devices | KTT | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 1, 2014 | K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 10, 2014 | K133578 | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| December 31, 2013 | K132629 | REPROCESSED DILATING TIP TROCARS | NLM | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| January 24, 2013 | K123334 | REPROCESSED STEERABLE INTRODUCER | DYB | Substantially Equivalent | Stryker Sustainability Solutions, Inc. | accessdata.fda.gov |
| October 21, 2011 | K112292 | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| September 26, 2011 | K112232 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| July 23, 2010 | K100909 | REPROCESSED COMPRESSION SLEEVES | JOW | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| May 28, 2010 | K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| March 19, 2010 | K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | NLM | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| October 21, 2009 | K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | OWQ | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| April 1, 2009 | K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| September 16, 2008 | K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| July 29, 2008 | K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| July 9, 2008 | K081329 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| September 5, 2006 | K061759 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| August 31, 2006 | K061045 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| February 24, 2006 | K060049 | REPROCESSED COMPRESSION SLEEVES | JOW | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| February 17, 2006 | K060091 | ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES | JOW | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| January 27, 2006 | K052918 | REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| August 25, 2005 | K052064 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| August 25, 2005 | K052062 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| August 22, 2005 | K052065 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| June 29, 2005 | K051554 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| March 23, 2005 | K043393 | REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| March 16, 2005 | K033436 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | OWQ | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| January 6, 2005 | K042316 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| October 3, 2003 | K030279 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| September 24, 2003 | K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical, Inc. | accessdata.fda.gov |
| August 8, 2003 | K030109 | ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| July 30, 2003 | K032058 | MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| May 2, 2003 | K030026 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| February 3, 2003 | K023714 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| October 4, 2002 | K012344 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| August 13, 2002 | K012708 | ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| June 24, 2002 | K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES | KTW | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| June 24, 2002 | K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | KTW | Substantially Equivalent | Alliance Medical, Inc. | accessdata.fda.gov |
| June 24, 2002 | K012623 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 7, 2001 | K012635 | REPROCESSED STRYKER ARTHROSCOPIC SHAVERS | HRX | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 7, 2001 | K012603 | REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS | NUJ | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| October 22, 2001 | K012625 | REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| February 19, 1991 | K910512 | ACCUFLATE | KCY | Substantially Equivalent | Instrumed, 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 |
|---|---|---|---|---|---|---|
| August 19, 2026 | 99634 | Class II | Ongoing | REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM | Reusable access port system may crack or seperate during use. | accessdata.fda.gov |
| August 18, 2026 | 99655 | Class II | Ongoing | BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 | Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter. | accessdata.fda.gov |
| April 10, 2026 | 98708 | Class II | Ongoing | BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | accessdata.fda.gov |
| March 12, 2026 | 98504 | Class II | Ongoing | Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-13 | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. | accessdata.fda.gov |
| September 24, 2025 | 97694 | Class II | Ongoing | HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY | Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. | accessdata.fda.gov |
| July 2, 2024 | 95038 | Class II | Ongoing | Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A | Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended. | accessdata.fda.gov |
| May 31, 2024 | 94824 | Class II | Ongoing | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. | accessdata.fda.gov |
| June 21, 2023 | 92655 | Class II | Ongoing | HoverMatt, 39" W x 78" L, REF: HM39SPU-B | 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in ski | accessdata.fda.gov |
| April 14, 2023 | 92138 | Class II | Ongoing | REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair,<12", Rx Only Non-Sterile | Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged. | accessdata.fda.gov |
| March 1, 2023 | 91845 | Class II | Ongoing | Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (P | Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss | accessdata.fda.gov |
| January 21, 2022 | 89535 | Class II | Terminated | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder | Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. | accessdata.fda.gov |
| January 19, 2021 | 87434 | Class II | Ongoing | Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and m | Product was distributed without receiving regulatory clearance. | accessdata.fda.gov |
| March 27, 2020 | 85413 | Class II | Terminated | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067 | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatme | accessdata.fda.gov |
| October 9, 2019 | 85330 | Class II | Terminated | Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients | Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force. | accessdata.fda.gov |
| December 17, 2018 | 81880 | Class II | Terminated | BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endoca | Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems. | accessdata.fda.gov |
| August 23, 2018 | 81321 | Class II | Terminated | Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart. | Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing. | accessdata.fda.gov |
| July 27, 2018 | 82063 | Class II | Terminated | Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries | Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used. | accessdata.fda.gov |
| June 19, 2018 | 81430 | Class II | Terminated | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturat | Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor. | accessdata.fda.gov |
| May 8, 2018 | 80329 | Class II | Terminated | Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tis | Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used. | accessdata.fda.gov |
| March 29, 2018 | 80324 | Class II | Terminated | Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping | Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic. | accessdata.fda.gov |
| January 2, 2018 | 79087 | Class II | Terminated | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for mult | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | accessdata.fda.gov |
| December 1, 2017 | 78714 | Class II | Terminated | 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing | 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. | accessdata.fda.gov |
| December 6, 2016 | 75941 | Class II | Terminated | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a m | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | accessdata.fda.gov |
| November 11, 2016 | 75675 | Class II | Terminated | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical proce | An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use. | accessdata.fda.gov |
| October 6, 2016 | 75409 | Class II | Terminated | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are special | The EP Catheters may be mislabeled for French size during reprocessing. | accessdata.fda.gov |
| September 19, 2016 | 75221 | Class II | Terminated | Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs app | Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention. | accessdata.fda.gov |
| June 1, 2016 | 74301 | Class I | Terminated | AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 | Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient. | accessdata.fda.gov |
| April 28, 2016 | 73983 | Class II | Terminated | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structu | Mislabeled for size | accessdata.fda.gov |
| April 4, 2016 | 73835 | Class II | Terminated | Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 | Device packaging may not be sealed. | accessdata.fda.gov |
| December 17, 2015 | 72880 | Class II | Terminated | Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremi | Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. | accessdata.fda.gov |
| October 14, 2015 | 72456 | Class II | Terminated | SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and dril | It was reported that packaging was not properly sealed. | accessdata.fda.gov |
| July 10, 2015 | 71805 | Class II | Terminated | Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH XCEL Un | Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST). | accessdata.fda.gov |
| June 1, 2015 | 71394 | Class II | Terminated | Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including th | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site. | accessdata.fda.gov |
| October 18, 2013 | 66712 | Class II | Terminated | Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, | Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal. | accessdata.fda.gov |
| August 30, 2012 | 63692 | Class II | Terminated | STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor). | Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. | accessdata.fda.gov |
Compare with other makers
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Updated September 16, 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.