Medline procedure kits labeled as: 1) ANGIO DRAPE PACK — Class II medical device recall Z-1437-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L

Recall number	`Z-1437-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated	2025-02-11
Classified	2025-03-25
Reported by FDA	2025-04-02
Distributed	Nationwide (US)
Countries outside the US	CA
Quantity	9,246 units
Reason classes	packaging, device malfunction
UPC / GTIN / UDI-DI	`10193489280463`, `10193489483147`, `10193489498998`, `10193489744644`, `10193489813128`, `10193489881424`, `10193489916478`, `10193489926101`, `10193489950243`, `10193489952940`, `10193489968156`, `10193489978759`, `10195327008581`, `10195327014001`, `10195327057763`, `10195327177423`, `10195327179557`, `10195327191566`, `10195327223977`, `10195327400156`, `10195327449452`, `10195327451585`, `10195327451813`, `10195327477387`, `10195327528331` and 41 more
Lot numbers	`20FMA718A`, `20KBM762A`, `21BBG459B`, `21EBP494A`, `21HBP168A`, `21JMF491A`, `21JMI207A`, `21LBW389A`, `22GBH915A`, `22HBO256A`, `22LBA182A`, `23BBR783A`, `23BBR790A`, `23CBL353A`, `23EBE626A`, `23EMD520A`, `23EME005A`, `23FMD837A`, `23GBF536A`, `23HMB245A`, `23HMC543A`, `23HME348A`, `23IMG363A`, `23KMC169A`, `23LBK499A`, `23LBL085Z`, `23LMD710A`, `23LME689A`, `23LME887A`, `23LMG342A`, `23LMG703A`, `23LMG954A`, `24ABA461Z`, `24AME980A`

Product

Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ61266A; 6) ANGIOGRAPHY PACK-LF, Pack Number DYNJ35916N; 7) ARTERIOGRAM PACK, Pack Number DYNJ34442F; 8) CARDIAC CATH FEMORAL PACK, Pack Number DYNJ53588I; 9) CARDIAC CATH PACK, Pack Number DYNJ31733C; 10) CARDIAC CATH PACK, Pack Number DYNJ41315A; 11) CARDIAC CATH PACK-LF, Pack Number DYNJ0380198L; 12) CATH LAB PACK, Pack Number 0M-CP31796Q; 13) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 14) CATH LAB TRAY, Pack Number 00-401610J; 15) CHRISTUS SR CATH LAB PACK, Pack Number DYNJ60931C; 16) CRMC CATH LAB TRAY JUDKINS-LF, Pack Number DYNJ61088F; 17) CRMC NEURO ENDO HYBRID-LF, Pack Number DYNJ61101D; 18) EP PACK MORNINGSIDE, Pack Number DYNJ69301; 19) FEMORAL TRAY 2, Pack Number DYNJ68812C; 20) INTERVENTIONAL MINOR PACK, Pack Number DYNJ24615D; 21) INTERVENTIONAL PACK, Pack Number DYNJ54253; 22) INTERVENTIONAL RADIOLOGY PK-LF, Pack Number PHS605358025B; 23) MORNINGSIDE CARDIAC CATH, Pack Number DYNJ58339A; 24) OR INTERVENTIONAL PACK, Pack Number DYNJ46934A; 25) PACK,CARDIAC CATH, Pack Number DYNJ65481; 26) PK, RADIOLOGY-SPECIALS, Pack Number DYNJ59628C; 27) PTCA TRAY-LF, Pack Number DYNJ07252V; 28) RADIOLOGY PACK, Pack Number DYNJ45393A; 29) RR-ANGIOGRAPHY DRAPE PACK-LF, Pack Number DYNJ0608549M; 30) SPEC ANGIO PACK (SASJK)642-LF, Pack Number DYNJ47586F; 31) SPECIALS LINE PACK, Pack Number DYNJ69504; 32) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 33) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 34) UTHET TYLER ELECTROPHYSIOLOGY, Pack Number DYNJ68672C

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

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-1437-2025. 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.