CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report
ACE(TM) Ultra Lite Ankle brace: (a) Size Selection Medium recalled
3M Company - Health Care Business is recalling ACE(TM) Ultra Lite Ankle brace: (a) Size Selection Medium, distributed in 32 states. The recall was initiated on 1 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0552-2018
- FDA event ID
- 78444
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2017
- FDA classified
- 7 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Device type
- Other Medical Devices
Timeline
| 1 Nov 2017 | Recall initiated by company | |
| 7 Feb 2018 | Classified by FDA | +98 days |
| 14 Feb 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Product as listed by the FDA
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
Where it was 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
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Which lots are affected?
(a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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