CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report

Medicine Cup Liquid medication dispenser to issue recalled

Medline Industries is recalling Medicine Cup Liquid medication dispenser to issue a measured amount of liquid medication. The recall was initiated on 11 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers 122211502  122212515
Quantity recalled903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2404-2016
FDA event ID
74664
Recalling firm
Medline Industries, Mundelein, IL
Classification
Class II
Status
Terminated
Recall initiated
11 May 2016
FDA classified
11 Aug 2016
Reported
17 Aug 2016
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

11 May 2016Recall initiated by company
11 Aug 2016Classified by FDA+92 days
17 Aug 2016Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There 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.

Product as listed by the FDA

Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.

Where it was distributed

Continental U.S.

Questions about this recall

Why was it recalled?

There 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.

Which lots are affected?

Lot Numbers 122211502  122212515

Where was it sold?

Continental U.S.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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