Reported Aug 13, 2025 · Ongoing
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711
Is this the product you have?
Stryker SmartPump Tourniquetdisposable sterile (single use) DISP 18X31BLA1PRT QUICK / 5921-018-135DISP 18X31BLA2PRT QUICK / 5921-018-235DISP 24X41BLA2PRT QUICK / 5921-024-235
- Lot codes and dates
- 5921-018-135 GTIN 07613154599257 5921-018-235 GTIN 07613154599295 5921-024-235 GTIN 07613154599370
- Amount recalled
- 233.230
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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