RegWardenFDA facility compliance records
Recall

Class II — MEDLINE INDUSTRIES INC

Recalling firmMedline Industries, LP
Registered facilityView this company's 31 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonFirm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
ProductUnna-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.
Quantity113,302 units
DistributionUnited States, Taiwan, Chile
Initiated2018-08-30
Classified2018-10-06
Terminated2023-02-09
Recall numberZ-0088-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — MEDLINE INDUSTRIES INC (Z-0088-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80972/

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