Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 592...

FDA Device Recall #Z-2277-2025 - Class II, July 2, 2025

Recall Summary

Recall Number Z-2277-2025
Classification Class II - Moderate risk
Date Initiated July 2, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Corporation
Location Portage, MI
Product Type Devices
Quantity 233.230

Product Description

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 Pattern

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

Lot / Code Information

5921-018-135 GTIN 07613154599257 5921-018-235 GTIN 07613154599295 5921-024-235 GTIN 07613154599370

Other Recalls from Stryker Corporation

Recall # Classification Product Date
Z-2865-2026 Class II STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Nu... Jun 8, 2026
Z-2863-2026 Class II STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catal... Jun 8, 2026
Z-2862-2026 Class II STRYKER AHTO TUBE SET PACKAGING, Catalog Number... Jun 8, 2026
Z-2866-2026 Class II STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, ... Jun 8, 2026
Z-2864-2026 Class II STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Cat... Jun 8, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.