The FDA announced on Jan. 12, 2024, that 3M Company - Health Care Business is recalling 3M Specialty Blade Assembly REF 9660 due to burn hazards. The agency issued recall number Z-1169-2024 for the Class II device.
How to tell if you have it
- Brand: 3M
- Product: 3M Specialty Blade Assembly
- REF: 9660, 70-2011-8462-2, 7100213114
- Used with: 3M Surgical Clipper Catalog Number 9661L
- UDI/DI (shipper): 50707387789003
- UDI/DI (tray): 30707387789009
- Lot codes: all lot codes
- Quantity: 52,833,750 blades
- Distribution: Worldwide
The hazard
The recall addresses the risk of burns which may result in minor injury if users do not follow specific usage precautions. The FDA notes that blade temperatures can exceed safe limits if the clipper is left running unused in air or applied to the same skin location for too long.
Context
GovInfoNow's records show 3M Company - Health Care Business has 17 other recalls on record since 2015-08-06. Other recent recalls include 3M Clarity Precision Grip Attachments (2024-11-22) and 3M Tegaderm CHG Dressing (2024-08-14). A 2024-03-20 recall involved incorrect shelf life labeling for 3M Durapore Surgical Tape.