Class 1 Device Recall Medline medical convenience kits

• Date Initiated by Firm: March 24, 2026
• Date Posted: May 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2143-2026
• Recall Event ID: 98735
• Product Classification: Angiography/angioplasty kit - Product Code OEQ
• 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.
• Code Information: 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.
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer 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: 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.
• Quantity in Commerce: 508 kits
• Distribution: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.