Data Foundry

Medical device recalls 2025

MEDLINE PERFUSION SYRINGE — Class II medical device recall Z-0886-2026

Ongoing recall by Medline Industries, LP, reported 2025-12-17, distributed nationwide. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer

Recall numberZ-0886-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2025-10-27
Classified2025-12-05
Reported by FDA2025-12-17
DistributedNationwide (US)
Quantity15 units
Reason classessterility
UPC / GTIN / UDI-DI10193489621532, 40193489621533
Lot numbers25FMJ081
Model numbersDYNJ39223C

Product

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0886-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.