Skip to content

Medline Perfusion Syringe, Ref: Dynj39223c recallZ-0886-2026 · Medline Industries, LP · initiated Oct 27, 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

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignee on 10/27/2025 via email. The notice explained the issue, potential risk, and requested the affected product be quarantined. Once the firm receives the response form, Medline will provide over-labels which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use. Distributors and those further distributing the affected product are directed to notify those to whom the product was transferred or distributed of the recall. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-0886-2026
Status
Open, Classified
Initiated by the company
Oct 27, 2025
Posted by the FDA
Dec 5, 2025
Recalling firm
Medline Industries, LP
Quantity
15 units
Product code
OEZ
Distribution
US Nationwide distribution in the state of CA.

Product description

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Code information (models, lots, serial numbers)

UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081

Devices named in this recall

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

Sources and updates

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