# FDA recall Z-1315-2023

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2023-03-01.

## 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.

## Distribution

US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT

## Key facts

- **Recall number:** Z-1315-2023
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-01
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2023

## Citation

> AI Analytics. FDA recall Z-1315-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1315-2023. Source: US FDA. Licensed CC0.

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