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Lower risk Medical device recall · FDA · Published November 1, 2017

ACE Ultra Lite Ankle Brace Recall: Mold Risk from Aspergillus Candidus

3M recalls ACE Ultra Lite Ankle Braces with mold (Aspergillus candidus) on non-patient contact surfaces. Affected models include Size Medium Cat #901014 and Size Large Cat #901015 with specific lot numbers. Stop using immediately to avoid potential health risks.

🇺🇸 FDA recall #Z-0552-2018Medical deviceACE ›
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Recalling firm3M Company - Health Care Business3m Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN 55144-0001
✎ GovInfoNow plain-language explainer

3M is recalling ACE Ultra Lite Ankle Braces that have mold (Aspergillus candidus) on the non-patient contact surfaces. This mold can cause health issues if the brace is used, so affected owners should stop using the product immediately. Read more at govinfonow.com/recall/72640-ace-ultra-lite-ankle-brace-recall-mold-risk-from-aspergillus.

Source Summary by GovInfoNow · govinfonow.com/recall/72640-ace-ultra-lite-ankle-brace-recall-mold-risk-from-aspergillus · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0552-2018

Cite this page

“ACE Ultra Lite Ankle Brace Recall: Mold Risk from Aspergillus Candidus.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72640-ace-ultra-lite-ankle-brace-recall-mold-risk-from-aspergillus. Based on FDA recall #Z-0552-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2018%22&limit=1).

The FDA announced on 2017-11-01 that 3M Company - Health Care Business is recalling ACE(TM) BRAND, ULTRA LITE ANKLE braces due to mold contamination. The agency classified the recall as Class II.

How to tell if you have it

  • ACE(TM) BRAND, ULTRA LITE ANKLE brace
  • Size Selection Medium, Cat #901014, UPC 051131019984 2
  • Size Selection Large, Cat #901015, UPC 0 51131019985 9
  • Cat #901014 Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2
  • Cat #901015 Lot Number 7223U2

The hazard

Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.

Context

GovInfoNow's records show 3M Company - Health Care Business has 17 other recalls on record since 2015-08-06. Recent recalls include 3M Clarity Precision Grip Attachments (2024-11-22), 3M Tegaderm CHG Dressing (2024-08-14), and 3M Durapore Surgical Tape (2024-03-20). Other recent recalls of similar products include Medline Convenience Kits Recall (2026-08-11) and AVID Medical Halyard IV Start Kit Recalls (2026-07-22 and 2026-07-14).

How to tell if you have this one

Check for ACE Ultra Lite Ankle Braces with Size Medium (Cat #901014) or Size Large (Cat #901015). Look for lot numbers: 7223T2, 7133C2, 7144E2, 7332I2 for Size Medium and 7223U2 for Size Large.

  • Brand
    ACE
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discard the recalled ACE Ultra Lite Ankle Braces with mold on non-patient contact surfaces to avoid potential health risks.

Where it went and when

Where it was distributed

Distributed in 32 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: yesNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Missouri, New Hampshire, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Nov 1, 201712. FDA classified it Class II: Feb 7, 201823. Published in FDA’s Enforcement Report: Feb 14, 201834. FDA terminated the recall: Jul 22, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0552-2018 (November 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0552-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA