HIGH

Medline NAMIC RA Syringe Recall: 108 Units Worldwide for Unwinding Adaptor (High Risk)

Medline Industries, LP recalls 108 NAMIC Angiographic Rotating Adaptor Syringes sold worldwide, including the United States, PR and several international markets. The rotating adaptor may unwind during use, creating a loose connection or disconnection with the manifold. Healthcare providers must stop using the device and follow recall instructions.

Quick Facts at a Glance

Recall Date
February 27, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

NAMIC Angiographic Rotating Adaptor syringes are used in interventional cardiovascular procedures often with transcatheter aortic valve replacement (TAVR).

Why This Is Dangerous

A rotating adaptor that unwinds can create a loose connection or disconnect from the manifold, potentially impacting procedural integrity.

Industry Context

This recall is not described as part of a broader pattern in the provided data.

Real-World Impact

Immediate discontinuation required. Potential impact on cardiovascular procedures and patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check Medline SKU DYNJ84472 in the TAVR PACK
  2. Verify UDI 10195327369286 and case UDI 40195327369287
  3. Inspect lot numbers 23LBN016, 23KBL255, 23HBL885, 23FBV799

Where to find product info

FDA recall page linked in notice; Medline customer service

What timeline to expect

Refunds/replacements typically processed within weeks to months depending on provider response

If the manufacturer is unresponsive

  • Escalate to FDA recall program
  • File a complaint with your hospital risk management

How to prevent similar issues

  • Verify adaptor integrity before use in procedures
  • Follow Medline's official instructions for recall
  • Maintain updated device inventory controls

Documentation advice

Keep recall notice, batch/lot numbers, and correspondence with Medline for records

Product Details

Medline SKU DYNJ84472 within TAVR PACK. UDI/DI 10195327369286. Case UDI 40195327369287. Lot numbers 23LBN016, 23KBL255, 23HBL885, 23FBV799. Quantity: 108 units. Sold worldwide including US, PR, CA, NL, AU, KR, LK, PK, JP, AE, SG, SK.

Reported Incidents

No specific injuries or incidents are described in the provided recall notice.

Key Facts

  • 108 units recalled
  • High hazard class I
  • Syringe rotating adaptor unwinding risk
  • Worldwide distribution including US and PR
  • UDI/DI 10195327369286
  • Lot numbers 23LBN016, 23KBL255, 23HBL885, 23FBV799
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
LACERATIONELECTRICALOTHER

Product Classification

Product TypeAngiographic Rotating Adaptor (RA) Control Syringe
Sold At
Multiple Retailers

Product Details

Model Numbers
Medline SKU # DYNJ84472
UDI/DI each 10195327369286
UDI/DI case 40195327369287
Lot Numbers: 23LBN016
23KBL255
+2 more
Affected States
ALL
Report Date
April 15, 2026
Recall Status
ACTIVE

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