FDA Device recall Z-1343-2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS by Stryker, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1343-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker |
| Distribution | US |
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Reason
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
Identifiers
| code_info | GTIN: 07613327606133 Lot Numbers: 2022111801 2022112903 2022121201 2022121202 2022121203 2022121204 2022121205 2022121206 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1343-2023%22
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