Medline Convenience kits containing recalled Swan-Ganz… recallZ-2612-2026 · Medline Industries, LP · initiated May 28, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process change control
What the company is doing
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].
Recall details
- Recall number
- Z-2612-2026
- Status
- Open, Classified
- Initiated by the company
- May 28, 2026
- Posted by the FDA
- Jun 26, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 9,272 kits
- Product code
- OES
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Product description
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
Code information (models, lots, serial numbers)
UDI-DI 10195327033620 Lots 21KBN891 21KBO410 22ABA676 22ABY937 22BBN909 22BBT447 23ABO303
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ68530AMedline Industries, Inc. · Cardiac catheterization kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99209).
- Z-2606-2026 · Open, ClassifiedMedline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
- Z-2607-2026 · Open, ClassifiedMedline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ90…
- Z-2609-2026 · Open, ClassifiedMedline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
- Z-2610-2026 · Open, ClassifiedMedline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
- Z-2611-2026 · Open, ClassifiedMedline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
- Z-2613-2026 · Open, ClassifiedMedline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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