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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78444

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 01, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
3M Company - Health Care Business

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0552-2018
Recall number
Z-0552-2018
Initiated
November 01, 2017
Classification
Class II
Status
Terminated
Quantity
996 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Mold was found

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

(a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2

Distribution pattern

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