3M Surgical Clipper Blade Assembly Recalled Due to Burn Risk
3M recalled 764,580 Specialty Blade Assemblies for surgical clippers due to risk of burns from overheating. The blade can reach temperatures exceeding 77°C if left running improperly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with potential for burn injury to patients, but no reported illnesses or injuries. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
3M Company has recalled 764,580 Specialty Blade Assemblies (REF 9660) used with 3M Surgical Clipper Model 9661L due to the risk of burn injuries. The recall affects units distributed worldwide. The blade assembly can overheat during use or if left running without proper application to skin.
3M issued a cautionary statement advising users not to leave the clipper running unused in air for more than 1 minute, as blade temperature may exceed 41°C (105.8°F). If left running for 10 minutes, the Model 9660 blade can reach temperatures as high as 77°C (170.6°F). Additionally, users should not apply the blade to the same skin location for longer than 1 second, as continuous motion is required during proper use. The device should never be used on injured skin.
Healthcare facilities and clinicians using this device should follow the updated safety instructions from 3M. Consult 3M for guidance on proper use of affected blade assemblies, including the specific product codes listed in the recall notice.
The recalled product
- Product
- 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
- Manufacturer
- 3M Company - Health Care Business
- Hazard
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 50707387789294 (shipper)
- 30707387789290 (tray)
- all lot codes
Distribution
Distribution scope not specified by the agency.
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