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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker StrykeFlow Suction/Irrigators Recalled for Handpiece Malfunction

Agency Publication Date: July 23, 2025
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Summary

Stryker Corporation is recalling its StrykeFlow Disposable Suction/Irrigator devices because irrigation solution can leak into the handpiece and battery pack. This fluid leakage can cause the device to malfunction or stop working during a medical procedure. The recall includes models sold both with and without disposable tips, specifically catalog numbers 0250070500 and 0250070520. While Stryker has received complaints regarding leakage and malfunctions, no specific number of injuries has been disclosed.

Risk

If irrigation fluid enters the battery pack or internal handpiece components, the device may fail to operate correctly or lose power entirely. This can cause surgical delays or require medical staff to replace the device mid-procedure, potentially impacting patient care.

What You Should Do

  1. This recall affects Stryker StrykeFlow Disposable Suction/Irrigators, including models without disposable tips (REF 0250070500) and models with disposable tips (REF 0250070520).
  2. Check your medical inventory or device packaging for catalog numbers (REF) 0250070500 or 0250070520 and UDI codes 07613327061390 or 07613327061369.
  3. Stop using the recalled device. Contact Stryker or your medical equipment distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety information.

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 StrykeFlow Disposable Suction/Irrigator without Disposable Tip
Model / REF:
0250070500
UDI:
07613327061390

Recall #: Z-2170-2025

Product: Stryker StrykeFlow Disposable Suction/Irrigator with Disposable Tip
Model / REF:
0250070520
UDI:
07613327061369

Recall #: Z-2171-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97039
Status: Active
Manufacturer: Stryker Corporation
Sold By: Hospital supply chains; Medical device distributors
Manufactured In: United States
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.