FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
- Recall number
- Z-2404-2016
- Recalling firm
- Medline Industries Inc
- Product
- Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
- Status
- Terminated
- Initiated
- 2016-05-11
- Posted
- not on file
- Terminated
- 2019-06-03
- Reason
- 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
- 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
- 903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
- Distribution
- Continental U.S.
- Lot, serial or model codes
- Lot Numbers 122211502 122212515
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYW
- Firm FEI
- 1417592
- Firm city
- Mundelein
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28