Z-0552-2018Class II

ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size...

Name: Z-0552-2018 ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size...
Creator: 3M Company - Health Care Business
Published: 2017-11-01
License: https://open.fda.gov/license/

3M Company / initiated 2017-11-01 / Terminated / root cause: packaging

FDA source

3M Company - Health Care Business began a recall of 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 on 2017-11-01. FDA classified it as Class II and gives the reason as "Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0552-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-01
Posted: 2018-02-07
Terminated: 2020-07-22
Recalling firm: 3M Company
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
Product code: NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile
Reason for recall: Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm initiated their recall on 11/01/2017 by letter. The letter requested the consignee cease distribution of the recalled product, isolate it pending return. Distributors were asked to notify their customers including a copy of the 3M recall notice.
Quantity in commerce: 996 units
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 codes and lots: (a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0552-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0552-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-07

Product code NOC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)