The Recall Desk
SevereFDA (Devices)·Z-1721-2026·Announced 2026-04-15

Medline head, neck and heart cath packs recalled over syringe adaptor defect

Medline is recalling Head and Neck CDS-LF and Heart Cath Pack-LF convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Medline Industries, LP is recalling medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes. This action covers the HEAD AND NECK CDS-LF, Medline SKU CDS780138K, and HEART CATH PACK-LF, Medline SKU DYNJ36478B, among others listed in the recall notice. The action covers 594 kits.

Medline 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 the manifold. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, covering the United States nationwide including Puerto Rico, and Canada, the Netherlands, Australia, the Republic of Korea, Sri Lanka, Pakistan, Japan, the United Arab Emirates, Singapore and Slovakia. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected kits using the Medline SKU, UDI and lot numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by Medline.

The recalled product

Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medlin
Manufacturer
Medline Industries, LP
Category
Medical Device — Catheterization procedure pack
Hazard
Affected units
594

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Medline SKU # CDS780138K
  • UDI/DI each 10198459205552
  • UDI/DI case 40198459205553
  • Lot Number: 25EBR802
  • Medline SKU # DYNJ36478B
  • UDI/DI each 10889942814619
  • UDI/DI case 40889942814610
  • Lot Number: 25AMH487
  • Lot Number: 24JMC622
  • Lot Number: 24EMD869
  • Medline SKU # DYNJ910458
  • UDI/DI each 10195327692469
  • UDI/DI case 40195327692460
  • Lot Number: 24LLA039
  • Medline SKU # VASC1081C
  • UDI/DI each 10195327054519
  • UDI/DI case 40195327054510
  • Lot Number: 25HBU295
  • Medline SKU # VASC1510
  • UDI/DI each 10195327686888

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 19 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Related recalls

Same manufacturer · Medline Industries, LP

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Same hazard · disconnection risk

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