CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report
3M Specialty Blade Assembly recalled by 3M Company - Health Care
3M Company - Health Care Business is recalling 3M Specialty Blade Assembly. The recall was initiated on 12 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1169-2024
- FDA event ID
- 93825
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jan 2024
- FDA classified
- 21 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Surgical Instruments
Timeline
| 12 Jan 2024 | Recall initiated by company | |
| 21 Feb 2024 | Classified by FDA | +40 days |
| 28 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 41¿C (105.8¿F). " 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 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
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 41¿C (105.8¿F). " 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 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."
Which lots are affected?
UDI/DI 50707387789003 (shipper), 30707387789009 (tray), all lot codes
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93825| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 3M Specialty Blade Assembly recalled by 3M Company - Health Care | 3M Company - Health Care Business | Temperature Abuse | MN |
More recalls from 3M Company - Health Care Business
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Clarity Precision Grip Attachments, for use in orthodontic treatment recalled | 3M Company - Health Care Business | Device Malfunction | Nationwide |
| Device | CLASS II | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing recalled | 3M Company - Health Care Business | Other | MN |
| Device | CLASS II | 3M Durapore Surgical Tape recalled by 3M Company - Health Care | 3M Company - Health Care Business | Labeling Errors | Nationwide |
| Device | CLASS II | 3M Tube Securement Device, Small/PO x/PO recalled | 3M Company - Health Care Business | Packaging Defects | Nationwide |
| Device | CLASS II | 3M Specialty Blade Assembly recalled by 3M Company - Health Care | 3M Company - Health Care Business | Temperature Abuse | MN |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |