FDAClass IIDecember 17, 2025

Medline Perfusion Syringe recall

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Why was Medline Perfusion Syringe 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Recalling firm
Medline Industries, LP
Quantity
15 units
Distribution
US Nationwide distribution in the state of CA.
Recall date
December 17, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls