Medline Convenience Kits containing select SKUs of 10mL Polycarbonate… — Class II medical device recall Z-1883-2026

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-1883-2026`
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	`10193489226102`, `10193489235517`, `10193489356885`, `10193489360127`, `10193489527889`, `10193489546194`, `10193489688160`, `10193489753707`, `10195327066925`, `10195327246136`, `10195327323196`, `10195327366254`, `10195327431273`, `10195327538972`, `10195327664473`, `10195327664497`, `10198459005121`, `10888277958173`, `10889942779079`, `10889942820849`, `10889942825288`, `10889942952618`, `40193489226103`, `40193489235518`, `40193489356886` and 19 more
Lot numbers	`20ABB748`, `20ABV122`, `20BBA524`, `20CBN068`, `20EBG674`, `20EBW196`, `20FBD191`, `20FBR136`, `20FDA159`, `20HBS587`, `20HBV757`, `20JBC396`, `20JBT996`, `20XBH732`, `21ABE357`, `21ABF720`, `21ABI859`, `21ABJ490`, `21ABT166`, `21BBD481`, `21BBM590`, `21BBN949`, `21BBP639`, `21BDA005`, `21CBH747`, `21CBS148`, `21CBY049`, `21CBZ899`, `21CDA164`, `21DBE579`, `21DBH332`, `21DDA142`, `21DDB532`, `21EBB385`, `21EBI827`, `21EBS091`, `21EDA157`, `21FBD068`, `21FBP137`, `21FBT962` and 256 more

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G

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-1883-2026. 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.