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Recall Observatory FDA recall evidence

Device product

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Z-0886-2026

October 27, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 97968
Status
Ongoing
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-0886-2026

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide distribution in the state of CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.