Medical device recalls Moderate risk

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

Recall date
October 27, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0886-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
US Nationwide distribution in the state of CA.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

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