3M Recalls ACE Ultra Lite Ankle Braces Due to Mold Contamination
3M is recalling specific sizes of ACE Ultra Lite Ankle Braces because mold was found on non-patient contact surfaces. The mold was identified as Aspergillus candidus.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves mold on non-patient contact surfaces, which is a low-risk contamination issue without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
3M Company - Health Care Business is recalling 996 units of ACE(TM) BRAND, ULTRA LITE ANKLE braces. The recall affects Size Selection Medium (Cat #901014) and Size Selection Large (Cat #901015). The specific lot numbers involved are 7223T2, 7133C2, 7144E2, and 7332I2 for the Medium size, and 7223U2 for the Large size.
The recall was initiated because mold was found on the non-patient contact surfaces of the product. The mold was identified as Aspergillus candidus. The affected units were distributed in 32 states, including Alabama, Arizona, California, Florida, New York, and Texas.
Consumers who have these specific products should stop using them and contact 3M for instructions on how to return or dispose of the items. This recall is classified as Class II by the FDA.
The recalled product
- Product
- ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
- Manufacturer
- 3M Company - Health Care Business
- Hazard
- Affected units
- 996
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 (6)
- (a) Cat #901014
- Lot Numbers: 7223T2
- 7133C2
- 7144E2
- 7332I2 (b) Cat #901015
- Lot Number 7223U2
Distribution
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