Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905
Summary
The FDA issued a Class II for Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESI by Medline Industries, LP. Reason: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) prox.
Details
Source
Device Recall
External ID
Z-2610-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
Lot/Code 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
Quantity Affected: 9,272 kits
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.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-28
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2610-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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