Z-2607-2026Class II

Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A...

Name: Z-2607-2026 Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A...
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 CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART... 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-2607-2026
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 CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
Product code: OEZ Cardiovascular Procedure Kit
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: DYNJ901328G UDI-DI 10198459601538 Lots 26ABD786 26CBD768 26DBJ434 DYNJ903465K UDI-DI 10198459292743 Lots 25GDB257 26ADA464 26BDA587 26DDA021 DYNJ909090G UDI-DI 10198459406027 Lots 25LBH690 25LBP697 DYNJ906102M UDI-DI 10198459406409 Lots 25JBE315 25KBI700 25KBM827 25LBB028 26ABH106 26CBQ206 DYNJ902664M UDI-DI 10198459349126 Lots 25ILA177 25KLA500 DYNJ902664N UDI-DI 10198459675287 Lot 26BLA783

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2607-2026
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 OEZ

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)