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
- Company
- Stryker Corporation
- Recall Initiated
- July 2, 2025
- Posted
- August 7, 2025
- Recall Number
- Z-2277-2025
- Quantity
- 233.230
- Firm Location
- Portage, MI
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.
Distribution
Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom
Lot / Code Info
5921-018-135 GTIN 07613154599257 5921-018-235 GTIN 07613154599295 5921-024-235 GTIN 07613154599370
Root Cause
Equipment maintenance
Action Taken
On July 2, 2025, the firm notified customers via Urgent Medical Device Recall letters. Customers were instructed to locate and quarantine any affected products at their facility and return an enclosed business reply form to the firm. Stryker will provide a shipping label to return the affected product, and credit will be issued to affected customers upon receipt of the recalled product.