ACE — Class II medical device recall Z-0552-2018
Terminated recall by 3M Company - Health Care Business, reported 2018-02-14, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
| Recall number | Z-0552-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2017-11-01 |
| Classified | 2018-02-07 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-07-22 |
| Distributed | 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 |
| Quantity | 996 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Lot numbers | 7133C2, 7144E2, 7223T2, 7223U2, 7332I2 |
| Model numbers | 901014, 901015 |
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 for recall
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0552-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.