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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- Medline Industries Inc
- Hazard
- 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.
Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · mold contamination
See all →- CriticalAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-30
- SevereAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-23
- HighTurmeric capsules recalled over mold contamination in raw material lots
FDA (Food) · 2026-02-04
- ModeratePariva Marinated Labneh Bites Recalled for Potential Mold Contamination
FDA (Food) · 2024-08-21
- HighPariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination
FDA (Food) · 2024-08-21
Similar recalls
- HighMedline Recalls Unna Boot Compression Wraps Due to Mold Contamination
FDA (Devices) · 2018-10-17
- ModerateZinc paste bandage labeling omitted castor oil and calamine ingredients
FDA (Devices) · 2026-03-18
- HighMedline Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- ModerateMedline Remedy Barrier Ointment Recalled for Microbial Contamination
FDA (Drugs) · 2019-02-13
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02