Z-1169-2024Class II

3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper...

Name: Z-1169-2024 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper...
Creator: 3M Company - Health Care Business
Published: 2024-01-12
License: https://open.fda.gov/license/

3M Company / initiated 2024-01-12 / Open, Classified

FDA source

3M Company - Health Care Business began a recall of 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L on 2024-01-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1169-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-12
Posted: 2024-02-21
Recalling firm: 3M Company
Product: 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
Product code: LWK Razor, Surgical
Reason for recall: 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)."
FDA 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 [email protected]." 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 in commerce: 52,833,750 blades
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 50707387789003 (shipper), 30707387789009 (tray), all lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1169-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1169-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-21
Z-1170-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-21

Product code LWK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)