Medline Convenience Kits containing select SKUs of 10mL Polycarbonate… — Class II medical device recall Z-1878-2026

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-1878-2026`
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	`10193489343298`, `10193489415896`, `10193489461602`, `10193489562705`, `10193489610406`, `10193489616750`, `10193489751277`, `10193489859027`, `10193489968170`, `10195327013226`, `10195327031725`, `10195327099404`, `10195327203726`, `10195327263003`, `10195327271640`, `10195327286392`, `10195327324988`, `10195327347451`, `10195327351335`, `10195327355173`, `10195327393090`, `10195327440299`, `10195327483234`, `10195327495640`, `10195327525040` and 45 more
Lot numbers	`21AKA467`, `21CBL983`, `21CLA367`, `21DKA121`, `21FBE677`, `21FBQ067`, `21FLA054`, `21GBD658`, `21GBL566`, `21GBR689`, `21GLA195`, `21GLA734`, `21HBD840`, `21HBI622`, `21HLA612`, `21ILA348`, `21JBA358`, `21JBJ094`, `21JLA060`, `21JLA304`, `21KBF796`, `21KBJ217`, `21KBY182`, `21LBC437`, `21LBG769`, `21LBN952`, `21LLA062`, `21LLA164`, `22ABX397`, `22ALA074`, `22ALA885`, `22BBW042`, `22BBX515`, `22BLA931`, `22CBA514`, `22CLA063`, `22CLA337`, `22DBC423`, `22DBD732`, `22DBS770` and 278 more

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953

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-1878-2026. 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.