Recall
FDAHealthOctober 27, 2025

Medline Industries, LP — MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 27, 2025

US Nationwide distribution in the state of CA.

What's affected?

Product
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Lot code
25FMJ081

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 15 units.

View original FDA notice →

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