The Recall Desk
ModerateFDA (Devices)·Z-2404-2016·Announced 2016-08-17

Medline Medicine Cups Recalled for Incorrect Volume Markings

Medline Industries is recalling 1-ounce medicine cups because the 10 mL increment is incorrectly printed as 5 mL, creating a risk of medication dosing errors.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error that could result in medication dosing errors, fitting the criteria for moderate severity without reported injuries.

Plain-English summary

Medline Industries Inc is recalling 1-ounce Medicine Cups used to measure liquid medication. The recall involves 903 cases and 4,090 sleeves, totaling 8,605,000 units, distributed across the Continental U.S. The affected products are identified by Lot Numbers 122211502 through 122212515.

The recall was initiated because the volume markings on the cups are incorrect. Specifically, the text "5 mL" is printed next to the increment that should read "10 mL." While the other gradations are marked correctly, the sequence is listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL. This labeling error could lead to inaccurate measurement of liquid medication.

Consumers and healthcare facilities should stop using the affected medicine cups and contact Medline Industries for instructions on how to return or dispose of the product.

The recalled product

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

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)

  • Lot Numbers 122211502  122212515

Distribution

Distribution scope not specified by the agency.