Recall Z-2277-2025 ยท KCY Tourniquet, Pneumatic
Stryker Corporation
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
| Date | Aug 7, 2025 (initiated Jul 2, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Equipment maintenance |
| Action | 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. |
| Quantity | 233.230 |
| Distribution | Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.