ClearanceBrief
Recall Z-2610-2026 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

Medline Industries, LP

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

DateJun 26, 2026 (initiated May 28, 2026)
StatusOpen, Classified
ReasonKits 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.
Root causeProcess 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.
Quantity9,272 kits
DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.