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Medline Convenience kits containing recalled Swan-Ganz… recallZ-2611-2026 · Medline Industries, LP · initiated May 28, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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-2611-2026
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
LRO
FDA submissions
K213481
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 OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M

Code information (models, lots, serial numbers)

DYNJ909090B UDI-DI 10195327652432 Lots 24EBL051 24GBG271 CDS982523M UDI-DI 10195327560591 Lots 24ALA227 24BLA369 24CLA108 24CLA518 24DLA082 24ELB053 24ILA112

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99209).

Sources and updates

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