Class IOngoingZ-1716-2026

Medline Industries, LP recalls Medline medical convenience kits

Medline Industries, LPNorthfield, IL, United StatesReported Apr 15, 2026 · 3 months ago

Legal News Analyst · Apr 15, 2026

Reason for recall

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.

Lot / code information

Lot #: 24BBI341; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394
Lot #: 23LBP066; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394
Lot #: 23KBS305; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394
Lot #: 23JBA062; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394
Lot #: 23HBR594; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394
Lot #: 23DBR051; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304
Lot #: 24ABO014; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304
Lot #: 23KBW878; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304
Lot #: 23HBP761; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304
Lot #: 23FBW006; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304

What the firm is doing

Medline Industries, LP issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 2/27/2026 via USPS and email. The notice explained the issue, risk associated with syringe disconnection and loose connection, and request customers remove and destroy all Namic RA Syringes. Over-labels will be provided for any affected kits on hand stating that the affected syringes must be removed and discarded from further use. The only exception is in rare circumstances where angiography is urgently required, no alternative device is available, and postponing the procedure would place the patient at significant risk. Required Action: 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. 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. 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. 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. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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