Stop using nowMedical device recall · FDA · Published July 2, 2025
Stryker SmartPump Tourniquet Recall: Risk of Bleeding or Stroke During Use
Stryker recalls disposable tourniquets that may detach during use, causing bleeding, stroke, or death. Affected models include 5921-018-135 and others. Stop using immediately if you have these items.
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.
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Contact the company
📍Recalling firmStryker Corporation1941 Stryker Way · Portage, MI 49002-9711
“Stryker SmartPump Tourniquet Recall: Risk of Bleeding or Stroke During Use.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51918-stryker-smartpump-tourniquet-recall-risk-of-bleeding-or-stroke-during. Based on FDA recall #Z-2277-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2025%22&limit=1).
The FDA announced on July 2, 2025, that Stryker Corporation is recalling Stryker SmartPump Tourniquets because the cuff flange may detach from the bladder. This defect poses risks of hemorrhage, stroke, or death during use. Owners should contact Stryker for a replacement.
The tourniquet cuff flange may become detached from the bladder, potentially causing a leak during procedures. This can result in unexpected blood loss, cerebral hypotension, cardiovascular collapse, or death. For IVRA procedures, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Context
GovInfoNow's records show Stryker Corporation has issued 34 other recalls since November 17, 2017. Recent Stryker recalls include a June 8, 2026, recall for AHTO Tube Sets due to leaking handpieces and a May 6, 2026, recall for Neptune Smart Docking Stations citing electrical shock risks. Other recent recalls of similar products include the March 12, 2026, Stryker Color Cuff 18"/24" Quick Connect Dual Port Cuffs Recall and the June 9, 2026, Zimmer Sterile Tourniquet Hoses Recall.
How to tell if you have this one
Check for model numbers 5921-018-135, 5921-018-235, or 5921-024-235 on the packaging. These tourniquets were sold with GTINs 07613154599257, 07613154599295, or 07613154599370.
If you have the recalled tourniquets, stop using them right away to prevent potential bleeding or serious injury.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2277-2025 (July 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2277-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.