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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

3M Company - Health Care Business: 3M Surgical Clipper Blades Recalled for Potential Burn Risk

Agency Publication Date: February 21, 2024
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Summary

3M is recalling over 53 million Specialty Blade Assemblies (Model 9660) used with 3M Surgical Clipper 9661L due to a risk of the blades overheating during use. If the clipper is left running without being applied to the skin for more than one minute, or if it is held in one spot for longer than one second, the blade can reach temperatures between 105.8°F and 170.6°F. This overheating can cause minor burns to patients during surgical preparation. 3M has issued updated cautionary statements to ensure the safe handling of these devices during medical procedures.

Risk

The clipper blades can rapidly overheat if left running in the air or held stationary against the skin, with temperatures reaching as high as 170.6°F (77°C) in some models. This poses a direct risk of thermal burns to patients, particularly if used on injured skin or without continuous motion.

What You Should Do

  1. Identify if you have 3M Specialty Blade Assembly REF 9660 by checking the product packaging for UDI/DI 50707387789003 (shipper) or 30707387789009 (tray), or UDI/DI 50707387789294 (shipper) or 30707387789290 (tray).
  2. Ensure all staff using these clippers are aware of the updated safety warnings: Do not use on injured skin.
  3. Do not leave the clipper running unused in the air for more than 1 minute, as the blade temperature may exceed 105.8°F.
  4. Always maintain continuous motion during use; do not leave the blade on the same location of the skin for longer than 1 second.
  5. Be aware that if the Model 9660 blade runs unused for 10 minutes, it can reach a maximum temperature of 170.6°F (77°C).
  6. Contact your healthcare provider or 3M Company directly at 1-800-228-3957 for further instructions regarding these safety updates.
  7. Contact the FDA for additional questions at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Updated cautionary labeling and safety instructions

How to: Follow the new cautionary statements regarding skin contact time and air-running limits. Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: 3M Specialty Blade Assembly, REF 9660 (used with 3M Surgical Clipper 9661L)
Model / REF:
9660
70-2011-8462-2
7100213114
Z-1169-2024
Lot Numbers:
all lot codes
Product: 3M Specialty Blade Assembly, REF 9660 (used with 3M Surgical Clipper 9661L)
Model / REF:
9660
70-2011-8491-1
7100213026
Z-1170-2024
Lot Numbers:
all lot codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93825
Status: Active
Manufacturer: 3M Company - Health Care Business
Sold By: Worldwide distribution
Manufactured In: United States
Units Affected: 2 products (52,833,750 blades; 764,580 blades)
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 · 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.