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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

Covidien LP: AbsorbaTack Fixation Device Recalled for Potential Sterility Breach

Agency Publication Date: February 6, 2024
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Summary

Covidien LP is recalling 54 units of its AbsorbaTack Absorbable Fixation Device (model ABSTACK30) used in surgical hernia repairs. The packaging for these devices may have a weak seal on the side of the foil pouch, which can lead to a breach in the sterile and moisture barrier. If the product’s sterility is compromised, it could introduce contaminants during surgery. Consumers should identify the product by its model and lot number and contact the manufacturer immediately for guidance.

Risk

A weak seal on the product packaging allows for the potential entry of bacteria or moisture, which can lead to the use of a non-sterile device during surgery, increasing the risk of infection or other surgical complications.

What You Should Do

  1. Check your surgical inventory for the AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm with Model Number ABSTACK30.
  2. Verify the Lot number: N3J1860Y and GTIN: 20884523006527 on the device packaging to confirm if your product is affected.
  3. Do not use any devices identified as being part of this affected lot.
  4. Contact your healthcare provider or Covidien LP for specific instructions on returning the product and to discuss potential refunds or replacements.
  5. For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Contact the manufacturer or healthcare provider

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

Affected Products

Product: AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm
Model / REF:
ABSTACK30
Lot Numbers:
N3J1860Y

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93722
Status: Active
Manufacturer: Covidien LP
Manufactured In: United States
Units Affected: 54 units
Distributed To: California, Colorado, Florida, Illinois, Texas

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 · 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.