The Recall Desk

Manufacturer

Stryker Sustainability Solutions

72 recalls in our database name Stryker Sustainability Solutions as the manufacturing or recalling firm.

What the numbers show

Total
72
Critical
0
Severe
10
Most recent
2026-10-14

Of the 72 recalls from Stryker Sustainability Solutions we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–72 of 72

  • HighFDA (Devices)·Z-2426-2018·2018-07-18

    Stryker Recalls Reprocessed Coronary Sinus Diagnostic Catheters

    Stryker Sustainability Solutions is recalling 2,722 reprocessed Coronary Sinus Diagnostic EP Catheters because thrombogenicity tests showed they did not meet non-thrombogenic specifications.

    Product
    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 of cardiac structures; i.e., stimulation and recording…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0916-2018·2018-03-14

    Stryker Reprocessed EP Catheters Recalled for EEPROM Chip Error

    Stryker is recalling 170 reprocessed EP catheters because an EEPROM chip error may occur when used with CARTO navigation systems.

    Product
    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 multiple electrode electrophysiological mapping of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0917-2018·2018-03-14

    Stryker Recalls Reprocessed EP Catheters Due to Navigation System Error

    Stryker is recalling eight reprocessed electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.

    Product
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0272-2018·2017-12-27

    Stryker Recalls Mislabeled VenaFlow Calf Compression Garments

    Stryker is recalling 280 VenaFlow Calf Garments mislabeled as Pos-Lock Connectors in Texas due to labeling errors.

    Product
    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 blood circulation and reducing wound healing time on the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0964-2017·2017-01-18

    Stryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach

    Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheter cables because a breach in sterile packaging may have occurred, potentially rendering the product non-sterile.

    Product
    Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The…
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0963-2017·2017-01-18

    Stryker Recalls Reprocessed Ablation Catheter Cables Due to Sterility Concerns

    Stryker is recalling reprocessed ablation catheter cables because a breach in sterile packaging may have resulted in non-sterile product.

    Product
    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 multi-pin connector on the proximal end which connects…
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0765-2017·2016-12-21

    Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage

    Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or during use.

    Product
    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 procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2017·2016-11-16

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Mislabeled French Size

    Stryker Sustainability Solutions is recalling four reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters because they may be mislabeled for French size during reprocessing.

    Product
    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0324-2017·2016-11-09

    Stryker Recalls Reprocessed Pressure Tourniquet Cuffs Due to Leak Detection Issues

    Stryker Sustainability Solutions is recalling 1,695,760 reprocessed pressure tourniquet cuffs because the process for detecting leaks is flawed. Leaking cuffs may cause excessive blood loss or systemic leakage of local anesthetic.

    Product
    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 apply an adequate amount of pressure on the arterial blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2096-2016·2016-07-27

    Stryker Recalls Angiographic Catheters Due to Tip Breakage

    Stryker is recalling 167 AngioDynamics Soft Vu Omni Flush Angiographic Catheters because the tips broke off before use.

    Product
    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1708-2016·2016-06-01

    Stryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters

    Stryker Sustainability Solutions is recalling 18 reprocessed diagnostic electrophysiology catheters because they were mislabeled for size.

    Product
    Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1625-2016·2016-05-18

    Mallinckrodt Evac Tracheal Tubes Recalled for Unsealed Packaging

    Stryker is recalling four Mallinckrodt Evac Tracheal Tubes because the packaging may not be sealed, potentially compromising sterility.

    Product
    Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1626-2016·2016-05-18

    Stryker Launcher Guiding Catheter Recalled for Unsealed Packaging

    Stryker is recalling two units of the Launcher Guiding Catheter because the device packaging may not be sealed.

    Product
    Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0629-2016·2016-01-20

    Stryker Tourniquet Cuffs Recalled for Mislabeling Port Configuration

    Stryker is recalling 450 reprocessed tourniquet cuffs because they were mislabeled regarding their port configuration.

    Product
    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 extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0478-2016·2016-01-13

    Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion

    Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.

    Product
    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0235-2016·2015-11-18

    Stryker Recalls Reprocessed Surgical Drill Bits Due to Packaging Seal Issues

    Stryker Sustainability Solutions is recalling 1,202 reprocessed surgical drill bits and blades because packaging was not properly sealed.

    Product
    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 drill bone and bony structures. Reprocessed surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2015·2015-09-02

    Stryker recalls mislabeled 5mm trocar sleeves due to length discrepancy

    Stryker Sustainability Solutions is recalling 90 reprocessed trocar sleeves labeled as 100mm but containing 75mm models.

    Product
    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 Universal Trocar Stability Sleeve is a sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1835-2015·2015-07-01

    Stryker Recalls Optical Access Systems Due to Fracture Risk

    Stryker is recalling specific Optical Access Systems because they may fracture at the tip, leaving fragments at the surgical site.

    Product
    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2015·2015-07-01

    Stryker Recalls Fios First Entry Trocars Due to Fracture Risk

    Stryker is recalling Fios First Entry trocars because some may fracture at the distal tip, leaving fragments at the surgical site.

    Product
    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 thoracic, gynecologic laparoscopy and other abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2015·2015-07-01

    Stryker Recalls Trocars Due to Reported Fracture at Distal Tip

    Stryker is recalling specific cannula and seal models because they may fracture at the tip, leaving fragments at the surgical site.

    Product
    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2014·2013-11-27

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables

    Stryker Sustainability Solutions is recalling 46 reprocessed diagnostic electrophysiology catheters and cables due to a potential sterility breach in the package seal.

    Product
    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, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0840-2013·2013-02-27

    Stryker Recalls AC Power Adaptors for Restep DVT System

    Stryker is recalling AC Power Adaptors for the Restep DVT System because wires may come loose, preventing the unit from operating.

    Product
    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).
    Category
    Medical Device
    Distribution
    2 states