Z-2143-2026Class I

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit...

Name: Z-2143-2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit...
Creator: Medline Industries, LP
Published: 2026-03-24
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-03-24 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline... on 2026-03-24. FDA classified it as Class I and gives the reason as "Medline has identified the presence of particulate within the fluid path of the Manifolds". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2143-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-24
Posted: 2026-05-08
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA root cause: Under Investigation by firm
Action: Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-046 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 508 kits
Distribution: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Product codes and lots: Medline Kit Number/SKU DYNJ23532C: UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number: 25DMA809; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23GBA252; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23HBI873; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23IBR043; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23KBF277; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 24ABQ959; Medline Kit Number/SKU VASC1057: UDI/DI each 10889942431922, UDI/DI case 40889942431923, Lot Number: 25KMF194.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2143-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2139-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2140-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2141-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2142-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2143-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2144-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2145-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2146-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2147-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2148-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08

Product code OEQ

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)