The Recall Desk
HighFDA (Devices)·Z-1074-2017·Announced 2017-02-01

Medline Recalls Unna-Z Compression Wraps Due to Mold Contamination

Medline Industries is recalling Unna-Z compression wraps due to contamination with common mold species. The recall affects units distributed in the US and several international countries.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. While the source does not explicitly state that no illnesses were reported, it does not report any injuries or deaths. Under the rubric, a Class II recall without explicit reports of hospitalization or injury falls into the High category (Score 3), representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, Inc. is recalling Unna-Z Unna Boot Bandage 3x10 and 4x10 compression wraps. The recall is being conducted because the products were found to be contaminated with common mold, specifically Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum.

The affected products are identified by Unit Numbers NONUNNA3 and NONUNNA4, with Lot Numbers ranging from 52581 through 63599. A total of 117,059 units were distributed nationwide in the United States and to Chile, Peru, El Salvador, and Taiwan.

Consumers who have these products should stop using them and contact Medline Industries for further instructions or a refund. The recall is classified as Class II by the FDA.

The recalled product

Product
Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Affected units
117,059

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.