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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

Waldemar Link GmbH & Co. KG (Corp. Hq.): LINK Universal Handle Recalled Due to Potential Breakage Risk During Surgery

Agency Publication Date: September 24, 2024
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Summary

Waldemar Link has recalled 32 units of the LINK Universal Handle (Item Number 130-394/01), a stainless steel surgical instrument used in medical procedures. These specific lots may suffer from an immediate material failure and break in the middle when used for the first time during an operation. Patients or medical facilities holding these instruments should verify their lot codes immediately to prevent surgical complications. If you have an affected handle, you should contact your healthcare provider or the manufacturer for instructions on returning the device.

Risk

The instrument can break in half during a surgical procedure due to material failure. This poses a risk of surgical delay or potential injury if metal fragments or the broken tool impact the patient during the operation.

What You Should Do

  1. Immediately check your inventory for the LINK Universal Handle, with quick coupling, Stainless Steel, straight (Item Number 130-394/01) with UDI-DI 04026575215539.
  2. Verify if your device matches any of the following affected lot codes: C204156, C219063, C219064, C233033, C233034, or C332135.
  3. If you identify an affected handle, stop using it immediately and set it aside to ensure it is not used in any surgical procedures.
  4. Contact your healthcare provider or Waldemar Link GmbH & Co. KG (the manufacturer) to arrange for the return of the device and to discuss potential replacements or refunds.
  5. For additional questions or support, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for replacement or refund

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: LINK Universal Handle, with quick coupling, Stainless Steel, straight
Model / REF:
Item Number 130-394/01
UDI-DI: 04026575215539
Lot Numbers:
C204156
C219063
C219064
C233033
C233034
C332135

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95344
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Corp. Hq.)
Sold By: Hospital suppliers; Medical device distributors
Manufactured In: Germany
Units Affected: 32 devices
Distributed To: Florida, Kansas, Michigan, New Jersey, Virginia

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.