Medline Convenience kits containing recalled Swan-Ganz Catheters CABG… — Class II medical device recall Z-2613-2026

Ongoing recall by Medline Industries, LP, reported 2026-07-08, distributed nationwide. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breaka

Recall number	`Z-2613-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medline Industries, LP, Northfield, IL, United States
Recall initiated	2026-05-28
Classified	2026-06-26
Reported by FDA	2026-07-08
Distributed	Nationwide (US)
Quantity	9,272 kits
Reason classes	packaging, device malfunction
UPC / GTIN / UDI-DI	`10193489263046`, `10193489278231`, `10193489303407`, `10193489372199`, `10193489427141`, `10193489481730`, `10193489571905`, `10193489817461`, `10193489818710`, `10193489827460`, `10193489843729`, `10193489854923`, `10193489904659`, `10193489906844`, `10193489909364`, `10193489918397`, `10193489946680`, `10193489999082`, `10195327018016`, `10195327044572`, `10195327102524`, `10195327111151`, `10195327133160`, `10195327175559`, `10195327192808` and 18 more
Lot numbers	`21ABH889`, `21ABS254`, `21ABW164`, `21AKB056`, `21BBR951`, `21BKA389`, `21CBD905`, `21CBQ397`, `21CBU594`, `21CKA218`, `21CKA531`, `21DBE110`, `21DBG173`, `21DBH590`, `21DBT869`, `21DBT916`, `21DBU485`, `21DBV510`, `21DKA456`, `21DKA466`, `21DKA468`, `21DKA676`, `21EBA170`, `21EBH610`, `21EBM044`, `21EKA130`, `21EKA149`, `21FBD406`, `21FBF442`, `21FBJ060`, `21FBJ935`, `21FBK899`, `21FBS444`, `21FDB453`, `21FKA087`, `21FLA954`, `21GBC753`, `21GBJ159`, `21GBM142`, `21GBV619` and 316 more

Product

Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R DYNJ9855016S OPEN HEART ACCESSORY CDS CDS984289J OPEN HEART ANESTHESIA PACK CDS983849D CDS983849F CDS983849G OPEN HEART B CDS DYNJ900377P OPEN HEART BASIC B DYNJ904311C OPEN HEART CDS CDS983513F OPEN HEART CDS QVH CDS982523K CDS982523L CDS982523N OPEN HEART LINE SET UP DYNJ908179 DYNJ908179A OPEN HEART SUPPLEMENT DYNJ909116 DYNJ909116A DYNJ909116C DYNJ909116D SILVER CROSS OPEN HEART DYNJ906102J DYNJ906102K DYNJ906102L SM OPEN HEART PACK A&B DYNJ904749G DYNJ904749J VPH OPEN HEART DYNJ902664J DYNJ902664K DYNJ902664L

Reason for recall

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

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-2613-2026. 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.