The Recall Desk
HighFDA (Devices)·Z-1169-2024·Announced 2024-02-28

3M Surgical Blade Assembly Recalled for Burn Injury Risk During Use

3M is recalling the Specialty Blade Assembly (REF 9660) used with 3M Surgical Clippers worldwide due to burn risk if the blade overheats during operation. Approximately 52.8 million units affected across all lot codes.

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 documenting burn injury risk from blade overheating. No hospitalizations or actual injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

The 3M Specialty Blade Assembly (REF 9660), used with the 3M Surgical Clipper model 9661L, is subject to a worldwide recall affecting all lot codes and approximately 52.8 million units.

3M has issued a cautionary statement regarding burn injury risk from the surgical clipper blade. The blade can overheat if not used according to instructions. If the clipper is left running in air without skin contact for more than 1 minute, blade temperature may exceed 41°C (105.8°F). Prolonged operation without skin contact can cause even higher temperatures—the Model 9660 blade can reach 77°C (170.6°F) if left running for 10 minutes.

To prevent burn injury, users should: not use the clipper on injured skin; not apply the clipper blade to the same skin location for longer than 1 second; maintain continuous motion during use; and not leave the clipper running unused in air for more than 1 minute.

Anyone using this product should review the precautions and ensure proper operation.

The recalled product

Product
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
Manufacturer
3M Company - Health Care Business
Category
Medical Device — Surgical clippers
Hazard
Affected units
52,833,750

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 50707387789003 (shipper)
  • 30707387789009 (tray)
  • all lot codes

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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