The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1715-2026·Announced 2026-04-15

Medline custom manifold kits recalled over syringe adaptor unwinding risk

Medline is recalling custom manifold and cryo EP manifold kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use. 1,698 kits are affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 custom manifold kits including CSTM MANIFOLD KIT - TITUS (Medline SKU VASC1061), CSTM MANIFOLD KIT - FRYE (SKU VASC1074) and CRYO EP MANIFOLD KIT (SKU VASC1198), with the full list in the recall notice. The action covers 1,698 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 a number of international markets. 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. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT…
Manufacturer
Medline Industries, LP
Category
Medical Device — Manifold procedure kit
Hazard
Affected units
1,698

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 VASC1061
  • UDI/DI each 10889942464722
  • UDI/DI case 40889942464723
  • Lot Number 25IBN161
  • Lot Number 25GBF769
  • Medline SKU VASC1074
  • UDI/DI each 10889942611751
  • UDI/DI case 40889942611752
  • Lot Number 25HBN798
  • Lot Number 25GBL527
  • Medline SKU VASC1198
  • UDI/DI each 10193489664263
  • UDI/DI case 40193489664264
  • Lot Number 25GDA142
  • Medline SKU VASCSHPOFF1
  • UDI/DI each 10889942405503
  • UDI/DI case 40889942405504
  • Lot Number 25IBP989
  • Lot Number 25GBL526
  • Medline SKU VASCSLPON1

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

See all →

Same hazard · disconnection risk

See all →

Similar recalls