← FDA ENFORCEMENT
Z-2610-2026Class II

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Firm state
IL
Product quantity
9,272 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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.

Product description

Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G

Code / lot info

DYNJ905503D UDI-DI 10193489430295 lots 21DBG611 21EBI605 21FBN751 DYNJ905503F UDI-DI 10193489967272 lots 21HBL060 21IBW859 22DBC340 22DBS437 22FBR267 22GBR286 22HBS560 22IBA577 22JBI883 22KBD587 22LBF425 23BBN903 23CBL450 23CBW776 23FBC209 23IBU343 24DBQ181 24FBT062 24GBR740 24HBI428 24JBP984 DYNJ905503G UDI-DI 10198459200397 lots 25ABJ069 25ABL749 25CBB762 25DBG799 25EBM994 25GBW226 25LBA950 25LBT019 26ABH519 26ABT315 26BBQ338 26DBJ110

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.