Medline Convenience Kits containing select SKUs of 10mL Polycarbonate… — Class II medical device recall Z-1891-2026

Ongoing recall by Medline Industries, LP, reported 2026-04-29, distributed nationwide. Unapproved design changes to the products outside of the 510(k) clearance.

Recall number	`Z-1891-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medline Industries, LP, Northfield, IL, United States
Recall initiated	2026-02-27
Classified	2026-04-17
Reported by FDA	2026-04-29
Distributed	Nationwide (US)
Countries outside the US	BB, CA, PA
Quantity	270,311 total
Reason classes	unapproved product
UPC / GTIN / UDI-DI	`10193489271485`, `10193489325485`, `10193489939682`, `10193489972221`, `10195327355302`, `10195327397340`, `10195327476458`, `10195327517380`, `10195327526061`, `10195327599140`, `10198459239328`, `40193489271486`, `40193489325486`, `40193489939683`, `40193489972222`, `40195327355303`, `40195327397341`, `40195327476459`, `40195327517381`, `40195327526062`, `40195327599141`, `40198459239329`
Lot numbers	`00-402001U`, `21AMC932`, `21CMB295`, `21EMA842`, `21EMA842Z`, `21GBL509`, `21GME190`, `21IMF074`, `21JBN647`, `21JBZ697`, `21JMA971`, `22AMB224`, `22BBX248`, `22CMF849`, `22CMG025`, `22DBL467`, `22DBS962`, `22DMF774`, `22FMB867`, `22GBC939`, `22HBO291`, `22HBO322`, `22HMD145`, `22HMH991`, `22IBN444`, `22IBO023`, `22JMF788`, `22KBT315`, `23AMH034`, `23BBA151`, `23CBI235`, `23CMA447`, `23DBM140`, `23DMC237`, `23DME176`, `23EBT729`, `23EDA007`, `23EMC431`, `23FMG987`, `23GBR995` and 61 more

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C

Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1891-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.