Color Cuff Single Port — Class II medical device recall Z-1315-2023
Ongoing recall by Stryker Sustainability Solutions, reported 2023-04-05, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pre
| Recall number | Z-1315-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | AK, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY |
| Quantity | 127,894 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00885825016142, 00885825016166, 00885825016173, 00885825016197, 00885825016296, 00885825016500 |
| Lot numbers | 0000172314, 0000172873, 0000176566, 0000177131, 0000186596, 0000187310, 0000187746, 0000188863, 0000192465, 0000192466, 0000192977, 0000192978, 0000192979, 0000192980, 0000192981, 0000193176, 0000193177, 0000193178, 0000193179, 0000193181, 0000193391, 0000193392, 0000193393, 0000193412, 0000193413, 0000193838, 0000193839, 0000193840, 0000193841, 0000194227, 0000194228, 0000194229, 0000194230, 0000194232, 0000194242, 0000194243, 0000195067, 0000195068, 0000195069, 0000195070 and 186 more |
| Model numbers | 0000172314, 0000172873, 0000176566, 0000177131, 0000186596, 0000187310, 0000187746, 0000188863, 0000192465, 0000192466, 0000192977, 0000192978, 0000192979, 0000192980, 0000192981, 0000193176, 0000193177, 0000193178, 0000193179, 0000193181, 0000193391, 0000193392, 0000193393, 0000193412, 0000193413 and 213 more |
Product
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;
Reason for recall
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
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-1315-2023. 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.