# FDA recall Z-2277-2025

> **Stryker Corporation** · Class II · device recall initiated 2025-07-02.

## Product

Stryker SmartPump Tourniquet, disposable sterile (single use)    DISP 18X3,1BLA,1PRT  QUICK / 5921-018-135;    DISP 18X3,1BLA,2PRT  QUICK / 5921-018-235;    DISP 24X4,1BLA, 2PRT  QUICK / 5921-024-235

## Reason for recall

Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.

## Distribution

Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom

## Key facts

- **Recall number:** Z-2277-2025
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-02
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2277-2025

## Citation

> AI Analytics. FDA recall Z-2277-2025. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2277-2025. Source: US FDA. Licensed CC0.

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