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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmMay 28, 2026
Date PostedJune 26, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2610-2026
Recall Event ID 99209
Product Classification Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
ProductMedline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
Code Information 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
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer 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 Determined
Cause 2		Process change control
ActionOn 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 recalls@medline.com.
Quantity in Commerce9,272 kits
DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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