FDA Medical Device Recalls (openFDA)
3M Company - Health Care Business: 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
- Recall number
- Z-1169-2024
- Recalling firm
- 3M Company - Health Care Business
- Product
- 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
- Status
- Open, Classified
- Initiated
- 2024-01-12
- Posted
- 2024-02-21
- Terminated
- not on file
- Reason
- 3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F)."
- Root cause
- Under Investigation by firm
- Action
- 3M issued a Medical Device Safety Notification - First Notice to its consignees on 01/12/2024 via USPS certified mail and email. The notice explained the issue and its decision to notify its consignees of an added caution statement regarding the use of the product: Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F). Users were asked to take the following actions: "" Ensure this safety notification is passed to all those who need to be aware within your organization or to any department where the affected product has been transferred. " Continue to use the product as intended, following the additional caution statement above. " Complete the attached Customer Acknowledgement Form acknowledging that you have read and understood this letter and the additional caution statement. " Email the completed form to 3MFieldSafetyAction@montage72.com." For additional questions or need to report an adverse event, contact the 3M Health Care Customer Helpline at 1-800-228-3957, option 7.
- Quantity
- 52,833,750 blades
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 50707387789003 (shipper), 30707387789009 (tray), all lot codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LWK
- Firm FEI
- 2110898
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28