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
ReasonThere is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup has the correct mL markings for the other gradations, but sequentially, the markings are listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL.
ProductMedicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
Quantity903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
DistributionContinental U.S.
Initiated2016-05-11
Classified2016-08-11
Terminated2019-06-03
Recall numberZ-2404-2016
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-2404-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74664/

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