FDA Device recall Z-0552-2018
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2 by 3m Health Care Business, citing mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0552-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-01 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | 3m Health Care Business |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV |
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
Reason
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Identifiers
| upc | 0511310199842 |
|---|---|
| upc | 0511310199859 |
| code_info | (a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2018%22
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