Medline Industries, LP recalls MEDLINE PERFUSION SYRINGE

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.

Medline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignee on 10/27/2025 via email. The notice explained the issue, potential risk, and requested the affected product be quarantined. Once the firm receives the response form, Medline will provide over-labels which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use. Distributors and those further distributing the affected product are directed to notify those to whom the product was transferred or distributed of the recall. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

• FDA enforcement recordOfficial FDA database entry for Z-0886-2026
• FDA device classification · OEZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medline Industries, LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.