Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP… — Class II medical device recall Z-1344-2023
Ongoing recall by Stryker Corporation, reported 2023-04-12, distributed nationwide. Not able to achieve desired pressure and not holding pressure result from two different causes which have been
| Recall number | Z-1344-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-04-04 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 07613327606164 |
| Lot numbers | 2022111802, 2022112904, 2022121301, 2022121302, 2022121905, 2022121906, 2022121907, 2022121908 |
| Model numbers | 5921-218-235NS |
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Reason for recall
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.