Stryker Corporation: Device Recall

Recall #Z-2277-2025 · 07/02/2025

Class II: Risk

Recall Details

Recall Number: Z-2277-2025
Classification: Class II
Product Type: Device
Recalling Firm: Stryker Corporation
Status: Ongoing
Date Initiated: 07/02/2025
Location: Portage, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 233.230

Reason for Recall

Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.

Product Description

Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235

Distribution Pattern

Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom

Other Recalls by Stryker Corporation

Class II: Risk 10/31/2025

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Class II: Risk 10/31/2025

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Class II: Risk 10/31/2025

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Class II: Risk 06/18/2025

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Class II: Risk 06/18/2025

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

View all recalls by Stryker Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.