FDA Medical devices recall ·

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT… recall

Recall number
Z-2609-2026
Date
(initiated May 28, 2026)
Company / brand
Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
9,272 kits
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

DYNJ905855 UDI-DI 10193489546606 Lots 21ABU297 21BBB235 21DBV520 21FBG162 21GBC672 21GBI192 21IBT387 21VBB580 22DBK812 22FBR093 22FBS035 22HBI628 22IBV291 22JBX729 22NBE430 23ABD954 23BBI465 23CBO951 23CBX474 23GBF721 DYNJ905857 UDI-DI 10193489545678 Lots 21ABG510 21GBK940 DYNJ905936B UDI-DI 10193489422818 Lots 21BBF766 21DBP452 21FBF248 21LBJ459 22ABV319 22DBS751 22FBU868

Distribution

US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.

States: Arizona California Florida Illinois Missouri New Jersey Ohio Oklahoma Tennessee Texas Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2609-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.