Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP… — Class II medical device recall Z-1339-2023
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-1339-2023 |
|---|---|
| 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 | 07613327606157 |
| Lot numbers | 2022111803, 2022112901, 2022121911, 2022121912, 2022122601, 2022122602 |
| Model numbers | 5921-030-135NS |
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS 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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1339-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.