Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet… — Class II medical device recall Z-0629-2016
Terminated recall by Stryker Sustainability Solutions, reported 2016-01-20, distributed nationwide. Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they
| Recall number | Z-0629-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2015-12-17 |
| Classified | 2016-01-12 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 450 devices |
| Reason classes | labeling |
| Lot numbers | 3490521, 3531111, 3733336, 3759409, 3822485, 4002152 |
| Model numbers | 5921-024-236, 5921-034-135, 5921-034-235, 5921-044-135, 5921-218-135 |
Product
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.
Reason for recall
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
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-0629-2016. 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.