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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Stryker SmartPump Tourniquet Recalled for Flange Detachment and Leakage Risk

Agency Publication Date: August 7, 2025
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Summary

Stryker Corporation is recalling 233 units of the SmartPump Tourniquet (disposable sterile, single use) because the cuff flange may detach from the bladder. This defect can cause a leak during a medical procedure, which may result in unexpected blood loss or other serious cardiovascular complications. The recall includes specific disposable models and sizes used in surgical settings to control blood flow.

Risk

A leak in the tourniquet cuff during surgery can lead to severe hemorrhage, cardiovascular collapse, stroke, or death. In procedures involving regional anesthesia, a leak could also cause rapid absorption of anesthetics into the patient's system, leading to drug toxicity.

What You Should Do

  1. This recall affects disposable sterile Stryker SmartPump Tourniquets with model numbers 5921-018-135, 5921-018-235, and 5921-024-235.
  2. Check the model number and GTIN printed on the product packaging; affected codes include GTINs 07613154599257, 07613154599295, and 07613154599370.
  3. Stop using the recalled device. Contact Stryker Corporation or your distributor to arrange for a return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Stryker SmartPump Tourniquet, disposable sterile (single use)
Variants: DISP 18X3, 1BLA, 1PRT QUICK, DISP 18X3, 1BLA, 2PRT QUICK, DISP 24X4, 1BLA, 2PRT QUICK
Model / REF:
5921-018-135
5921-018-235
5921-024-235
GTIN:
07613154599257
07613154599295
07613154599370

Quantity affected: 233 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97133
Status: Active
Manufacturer: Stryker Corporation
Sold By: Authorized medical distributors; Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 233.230
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.