Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine — Class II medical device recall Z-0088-2019
Terminated recall by MEDLINE INDUSTRIES INC, reported 2018-10-17. Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as c
| Recall number | Z-0088-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES INC, Northfield, IL, United States |
| Recall initiated | 2018-08-30 |
| Classified | 2018-10-06 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2023-02-09 |
| Countries outside the US | CL, TW |
| Quantity | 113,302 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
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 for recall
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0088-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.