Z-2610-2026Class II

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

Name: Z-2610-2026 Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D...
Creator: Medline Industries, LP
Published: 2026-05-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-05-28 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G on 2026-05-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2610-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-28
Posted: 2026-06-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
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.
FDA root cause: Process change control
Action: On May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 9,272 kits
Distribution: US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2610-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2606-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2607-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2608-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2609-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2610-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2611-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2612-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2613-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)