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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80972

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

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Event summary

Timeline bucket
August 30, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MEDLINE INDUSTRIES INC

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

Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.

Z-0088-2019
Recall number
Z-0088-2019
Initiated
August 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
MEDLINE INDUSTRIES INC
Quantity
113,302 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Environmental control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

Code information

Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.

Distribution pattern

United States, Taiwan, Chile