The FDA announced on 2017-11-01 that 3M Company - Health Care Business is recalling ACE(TM) BRAND, ULTRA LITE ANKLE braces due to mold contamination. The agency classified the recall as Class II.
How to tell if you have it
- ACE(TM) BRAND, ULTRA LITE ANKLE brace
- Size Selection Medium, Cat #901014, UPC 051131019984 2
- Size Selection Large, Cat #901015, UPC 0 51131019985 9
- Cat #901014 Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2
- Cat #901015 Lot Number 7223U2
The hazard
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Context
GovInfoNow's records show 3M Company - Health Care Business has 17 other recalls on record since 2015-08-06. Recent recalls include 3M Clarity Precision Grip Attachments (2024-11-22), 3M Tegaderm CHG Dressing (2024-08-14), and 3M Durapore Surgical Tape (2024-03-20). Other recent recalls of similar products include Medline Convenience Kits Recall (2026-08-11) and AVID Medical Halyard IV Start Kit Recalls (2026-07-22 and 2026-07-14).