CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report

Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap recalled

Medline Industries is recalling Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per, 3- x 10yds, distributed nationwide in the US. The recall was initiated on 23 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUnit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599

Quantity recalled117,059 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1074-2017
FDA event ID: 76132
Recalling firm: Medline Industries, Mundelein, IL
Classification: Class II
Status: Terminated
Recall initiated: 23 Nov 2016
FDA classified: 23 Jan 2017
Reported: 1 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Mold
Device type: Other Medical Devices

Timeline

23 Nov 2016	Recall initiated by company
23 Jan 2017	Classified by FDA	+61 days
1 Feb 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage 4X10 due to contamination of the products with common mold (Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum)..

Product as listed by the FDA

Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds

Where it was distributed

Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599

Where was it sold?

Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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