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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker SmartPump Tourniquet

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 Class 2 Device Recall Stryker SmartPump Tourniquetsee related information
Date Initiated by FirmJuly 02, 2025
Date PostedAugust 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2277-2025
Recall Event ID 97133
Product Classification Tourniquet, pneumatic - Product Code KCY
ProductStryker 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
Code Information 5921-018-135 GTIN 07613154599257 5921-018-235 GTIN 07613154599295 5921-024-235 GTIN 07613154599370
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactRichard Kensinger
269-800-1941
Manufacturer 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.
FDA Determined
Cause 2		Equipment maintenance
ActionOn 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 in Commerce233.230
DistributionDomestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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