Recall Z-2147-2026

Medline Industries, LP · initiated March 24, 2026

Class I Open, Classified

Class I – dangerous or defective products that could cause serious health problems or death

Product

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.

Codes / lots: Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341…

Reason for recall

Medline has identified the presence of particulate within the fluid path of the Manifolds.

FDA-determined cause: Under Investigation by firm

Action taken

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 recalls@medline.com.

Details

Recall number
Z-2147-2026
Initiated
March 24, 2026
Posted by FDA
May 8, 2026
Product code
LRO – General Surgery Tray
Quantity
21119 kits
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2138-2026 Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038200…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2139-2026 Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038301…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2140-2026 Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038402…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2141-2026 Class INamic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2142-2026 Class INamic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2143-2026 Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2144-2026 Class I1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2145-2026 Class I1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2146-2026 Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified
Z-2148-2026 Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline…Medline has identified the presence of particulate within the fluid path of the Manifolds. 03/24/2026Open, Classified