Agency classClass IOur severity:Severe FDA (Devices)·Z-1729-2026·Announced 2026-04-15

Medline TAVR procedure packs recalled over syringe adaptor disconnection risk

Medline is recalling TAVR PACK convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold. 108 units 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 the TAVR PACK, Medline SKU DYNJ84472. The action covers 108 units.

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: TAVR PACK, Medline SKU # DYNJ84472
Manufacturer: Medline Industries, LP
Category: Medical Device — Cardiac procedure kit
Hazard: disconnection-risk
syringe-adaptor
class-i
structural-heart
device-malfunction
Affected units: 108

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 (7)

Medline SKU # DYNJ84472
UDI/DI each 10195327369286
UDI/DI case 40195327369287
Lot Numbers: 23LBN016
23KBL255
23HBL885
23FBV799.

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 →

Same manufacturer · Medline Industries, LP

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Same hazard · disconnection risk