Z-0886-2026Class II

Medline Perfusion Syringe, Ref: Dynj39223c

Name: Z-0886-2026 Medline Perfusion Syringe, Ref: Dynj39223c
Creator: Medline Industries, LP
Published: 2025-10-27
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-10-27 / Open, Classified / root cause: sterility

FDA source

Medline Industries, LP began a recall of MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C on 2025-10-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0886-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-27
Posted: 2025-12-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Perfusion Syringe, Ref: Dynj39223c
Product code: OEZ Cardiovascular Procedure Kit
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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 [email protected].
Quantity in commerce: 15 units
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0886-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0886-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-05

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)