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Medline Adult Anesthesia Set, REF DYNJ39985G recallZ-0137-2026 · Medline Industries, LP · initiated Sep 10, 2025

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

Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.

FDA root cause category: Process control

What the company is doing

Medline issue an UREGNE MEDICAL DEVICE NOTICE to its consignees on 9/10/2025 via email. The notice explained the issue, potential risk and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-25-193-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."

Recall details

Recall number
Z-0137-2026
Status
Open, Classified
Initiated by the company
Sep 10, 2025
Posted by the FDA
Oct 10, 2025
Recalling firm
Medline Industries, LP
Quantity
950 units
Product code
LRO
FDA submissions
K213481
Distribution
US Nationwide distribution in the states of MO.

Product description

Medline Adult Anesthesia Set, REF DYNJ39985G

Code information (models, lots, serial numbers)

UDI/DI 10198459062353 (EA) 40198459062354 (Case), Lot Numbers: 25GMB464

Devices named in this recall

1 device 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.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page