Z-1074-2017Class II

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

Name: Z-1074-2017 Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Creator: Medline Industries Inc
Published: 2016-11-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2016-11-23 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds on 2016-11-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1074-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-23
Posted: 2017-01-23
Terminated: 2019-07-19
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Product code: FQM Bandage, Elastic
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)..
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Medline Industries sent an Immediate Action letter dated November 23, 2016, to all affected customers with response forms to their customers. Customers were instructed to destroy the affected Unna Boot Bandages. Affected lots of product remaining at the firm's distribution centers have been placed on hold and quarantined pending destruction. All affected product will be destroyed. For further questions, please call (847) 643-3245.
Quantity in commerce: 117,059 units
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.
Product codes and lots: Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1074-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1074-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23

Product code FQM

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)