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Medium severity

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateOctober 27, 2025
ReportedDecember 17, 2025
Recalling firmMedline Industries, LP
Country / regionUnited States IL

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.

Affected products

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