Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2
FDA device recall Z-2277-2025 · posted 2025-08-07 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- 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.
- 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.
- Root cause
- Equipment maintenance
- Status
- Open, Classified
- Product code
- KCY
- Quantity affected
- 233.230
- Distribution
- Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom
- Date initiated
- 2025-07-02
- Date posted
- 2025-08-07
- Location
- Portage, MI
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