FDA Device recall Z-0664-2022
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
- FDA Device
- Class II
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder by Stryker Sustainability Solutions, citing mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0664-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-21 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | KS, OK, TX |
Product
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Reason
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Identifiers
| code_info | Lot # 12983349 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0664-2022%22
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