FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline Pill Splitters; 1 each/box; 144 boxes/carton
- Recall number
- Z-1287-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Pill Splitters; 1 each/box; 144 boxes/carton
- Status
- Open, Classified
- Initiated
- 2022-05-11
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.
- Root cause
- Process change control
- Action
- The firm issued a recall notice to consignees on 05/11/2022 via mail. The letter instructs the consignee to check their stock, destroy affected product, and return the response form. On 5/16/2022, the firm sent out an updated recall notice.
- Quantity
- 840,087 each
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Panama, and Hongkong.
- Lot, serial or model codes
- Model Number: NON135000; UDI/DI:8019673489; Lot Numbers: 50920060001, 50920080001, 50920110001, 50921030001, 50921040001, 50921050001, 50921060001, 50921080001, 50921090001, 50921100001, 50921110001, 50921120001, 50922020001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHY
- Firm FEI
- 1417592
- Firm city
- Northfield
- 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