Recall Z-1804-2026 ยท KCY Tourniquet, Pneumatic
Stryker Sustainability Solutions
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
| Date | Apr 9, 2026 (initiated Mar 12, 2026) |
| Status | Open, Classified |
| Reason | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. |
| Root cause | Nonconforming Material/Component |
| Action | On 03/12/2026, the firm sent via certified mail an "URGENT: Medical Device Recall" letter informing customers that there is a potential for Tourniquet Cuffs flange to detach from the bladder where the welding connection is, which may result in the cuff not able to maintain pressure. Customers are instructed to: 1. Inform individuals within their organization who need to be aware of this action. 2. Check their internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form (Attachment B) and return the comp |
| Quantity | 56,740 cuffs |
| Distribution | U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.