FDAOctober 27, 2025device

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

medline industries lpmedlinemedline industries

UPCs

1019348962153240193489621533

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C — Recall Details · AllClear