Z-2404-2016Class II

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

Name: Z-2404-2016 Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication
Creator: Medline Industries Inc
Published: 2016-05-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2016-05-11 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication on 2016-05-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2404-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-11
Posted: 2016-08-11
Terminated: 2019-06-03
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
Product code: KYW Container, Liquid Medication, Graduated
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline Industries sent a an URGENT RECALL letter dated 5/11/2016 to all affected consignees via certified mail. The URGENT RECALL letter described the reason for the recall and the actions to take.
Quantity in commerce: 903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
Distribution: Continental U.S.
Product codes and lots: Lot Numbers 122211502 122212515

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2404-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2404-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code KYW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)