# FDA recall Z-0552-2018

> **3M Company - Health Care Business** · Class II · device recall initiated 2017-11-01.

## 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.

## 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

## Key facts

- **Recall number:** Z-0552-2018
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-01
- **Report date:** 2018-02-14
- **Termination date:** 2020-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2018

## Citation

> AI Analytics. FDA recall Z-0552-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0552-2018. Source: US FDA. Licensed CC0.

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