RecallRadar

FDA Device recall Z-0088-2019

Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil po…

On 2018-10-17 the FDA classified a Class II recall of Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil po… by Medline Industries, citing firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0088-2019
ClassificationClass II
Statusterminated
Initiated2018-08-30
Published2018-10-17
Last updated2026-09-13 11:54 UTC
CompanyMedline Industries
Distributionn/a

Product

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.

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0088-2019%22

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