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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/Diagnostic Equipment

Parker Laboratories, Inc.: Tensive Conductive Adhesive Gel Recalled for Incorrect Viscosity

Agency Publication Date: February 29, 2024
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Summary

Parker Laboratories, Inc. has issued a voluntary recall for 44 cases (approximately 6,336 units) of Tensive Conductive Adhesive Gel, Product Ref. 22-60. This recall was initiated because the company received five complaints regarding the gel's viscosity, which refers to how thick or thin the substance is. The affected gel was sold in 50g tubes and distributed in 10 U.S. states and three foreign countries. Consumers should contact their healthcare provider or the manufacturer for guidance on what to do with the affected product.

Risk

If the gel does not have the correct thickness, it may not perform as expected during medical procedures, potentially affecting the conductivity or adhesion needed for medical devices. Five complaints have been reported regarding the consistency of the gel.

What You Should Do

  1. Locate your product and check the label for 'Tensive Conductive Adhesive Gel' with Product Ref. 22-60.
  2. Check the packaging for Lot Number A0623009 to see if your product is affected by this recall.
  3. Identify the specific units by looking for the following UDI numbers: 00855683006333 for individual tubes, 10855683006330 for inner boxes, and 20855683006337 for the master case.
  4. Contact Parker Laboratories, Inc., located at 286 Eldridge Rd, Fairfield, New Jersey, for specific instructions on how to return or handle the affected tubes.
  5. Consult your healthcare provider if you have concerns about medical procedures where this adhesive gel may have been used.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider consultation.

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

Affected Products

Product: Tensive Conductive Adhesive Gel (50g tubes)
Model / REF:
Product Ref. 22-60
UDI/DI (Master) 20855683006337
UDI/DI (Inner Box) 10855683006330
UDI/DI (Individual Unit) 00855683006333
Lot Numbers:
A0623009

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93891
Status: Active
Manufacturer: Parker Laboratories, Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 44 cases (6,336 units) (39 cases US, 5 cases OUS)
Distributed To: Arizona, California, Florida, North Carolina, New Jersey, Nevada, New York, Pennsylvania, Washington, Wisconsin

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.