HIGH

Medline NAMIC Angiographic Syringe Recall for 1.75 Million Kits Over Adaptor Unwinding Risk (2026)

Medline Industries, LP recalls 1,752,096 NAMIC Angiographic Syringe kits worldwide, including the US and Canada. The recall stems from a post-market signal about the rotating adaptor unwinding during use. This may cause a loose connection or disconnection between the syringe and manifold. Health care providers and patients should stop using the devices 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
Unknown
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 syringes are used in interventional radiology and angiography to inject contrast media. They come in various volumes and configurations for different procedural needs.

Why This Is Dangerous

The rotating adaptor may unwind, causing a loose connection or disconnection between the syringe and manifold. This can disrupt flow or cause air or material leakage during procedures.

Industry Context

This recall appears isolated to NAMIC angiographic syringes from Medline. It highlights post-market surveillance practices.

Real-World Impact

The recall involves 1.75 million kits, signaling a high potential impact on interventional procedures and hospital operations.

Practical Guidance

How to identify if yours is affected

  1. Identify SKU numbers and lot numbers in the recall documentation.
  2. Cross-check with your inventory to find affected syringes.
  3. Review accompanying labels for 20ML, 10ML, 12ML, and 12ML W/RES configurations.

Where to find product info

FDA enforcement page and Medline recall communications list SKUs and lots.

What timeline to expect

Replacements or refunds will be arranged through Medline; timelines commonly range several weeks.

If the manufacturer is unresponsive

  • Escalate to hospital risk management.
  • File a formal complaint with Medline and FDA if delays occur.

How to prevent similar issues

  • Verify adaptor fittings during incoming inspection.
  • Coordinate with biomedical engineering for protocol adjustments.
  • Maintain an up-to-date recall contact list for suppliers.

Documentation advice

Keep recall notices, batch/lot lists, correspondence, and purchase records.

Product Details

Medline NAMIC Angiographic Syringe kits. SKU list includes Medline SKUs 70075027, 70085007, 70085107, 70087007, 70087107, 70088007, 70095007, 70095107, 70097007, 70097107, 70098107, 80075027, 80085007, 80087007, 80095007, 80095107, 80097107. Quantity: 1,752,096 kits. Classification: Class I. Sold/distributed worldwide, including US, PR, CA, NL, AU, KR, LK, PK, JP, AE, SG, SK. Recall date: 2026-02-27. Report date: 2026-04-15. Hazard level: HIGH.

Reported Incidents

No specific injuries or incidents are cited in the provided data. The recall is based on post-market surveillance identifying a potential risk.

Key Facts

  • 1,752,096 kits recalled
  • Class I recall
  • Worldwide distribution including US, PR, CA, NL, AU, KR, LK, PK, JP, AE, SG, SK
  • Post-market surveillance identified risk of adaptor unwinding
  • Loose connection or disconnection between syringe and manifold
  • Stop-use-immediately and follow recall instructions
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
ELECTRICALLACERATIONOTHERSUFFOCATION

Product Classification

Product TypeAngiographic Syringe
Sold At
Unknown

Product Details

Model Numbers
Medline SKU # 60010027
UDI/DI each 10193489040166
UDI/DI case 30193489040160
Lot Number: 0000073035
Lot Number: 0000075896
+3 more
Affected States
ALL
Report Date
April 15, 2026
Recall Status
ACTIVE

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