REF: 5921-018-135 — Class II medical device recall Z-0664-2022
Terminated recall by Stryker Sustainability Solutions, reported 2022-03-02, distributed in KS, OK, TX. Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
| Recall number | Z-0664-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2022-01-21 |
| Classified | 2022-02-22 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2025-02-26 |
| Distributed | KS, OK, TX |
| Quantity | 40 units |
| Reason classes | labeling |
| Lot numbers | 12983349 |
| Model numbers | 5921-018-135 |
Product
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Reason for recall
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
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-0664-2022. 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.