Z-1287-2022Class II

Medline Pill Splitters; 1 each/box; 144 boxes/carton

Name: Z-1287-2022 Medline Pill Splitters; 1 each/box; 144 boxes/carton
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-05-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-05-11 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Pill Splitters; 1 each/box; 144 boxes/carton on 2022-05-11. FDA classified it as Class II and gives the reason as "Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1287-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-11
Posted: 2022-06-24
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Pill Splitters; 1 each/box; 144 boxes/carton
Product code: OHY Pill Crusher/Cutter
Reason for recall: Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.
FDA 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 in commerce: 840,087 each
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Panama, and Hongkong.
Product codes and lots: Model Number: NON135000; UDI/DI:8019673489; Lot Numbers: 50920060001, 50920080001, 50920110001, 50921030001, 50921040001, 50921050001, 50921060001, 50921080001, 50921090001, 50921100001, 50921110001, 50921120001, 50922020001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1287-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1287-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-24

Product code OHY

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)