Z-1463-2025Class II

Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

Name: Z-1463-2025 Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-02-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-11 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS on 2025-02-11. FDA classified it as Class II and gives the reason as "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1463-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-11
Posted: 2025-03-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
FDA root cause: Under Investigation by firm
Action: Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers.
Quantity in commerce: 1152 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: 1) Pack Number DYNJ60655D: UDI/DI 10195327464783 (each), 40195327464784 (case), Lot Number 24AMC692A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1463-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26
Z-1462-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26
Z-1463-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26
Z-1464-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26
Z-1465-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26

Product code KDD

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)