HIGH

Merit Medical Recalls Inflation Device Due to Detachment Hazard

Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.

Quick Facts at a Glance

Recall Date
December 4, 2025
Hazard Level
HIGH
Brand
Merit Medical Systems
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Inflation device handle may detach from the syringe during procedure.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The Allwell Inflation Device is used in angiographic procedures to inflate balloons within blood vessels. Medical professionals rely on this device for precision during critical cardiovascular interventions.

Why This Is Dangerous

The inflation device's handle detachment can interrupt procedures, potentially leading to severe complications or inadequate treatment outcomes.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using the device immediately, which may disrupt medical procedures and require alternative solutions.

Practical Guidance

How to identify if yours is affected

  1. Check if your device is from the affected lot numbers listed in the recall notice.
  2. Inspect the handle and syringe connection for any signs of wear or detachment.
  3. Contact your healthcare provider to confirm if your device is affected.

Where to find product info

The lot number can typically be found on the packaging or the device itself.

What timeline to expect

Expect a refund or replacement process to take approximately 4-6 weeks after initiating the return.

If the manufacturer is unresponsive

  • Reach out again via email or phone.
  • Document your communications and try different contact methods.

How to prevent similar issues

  • Look for devices with secure handle designs when purchasing medical equipment.
  • Check for recent recalls before using medical devices.
  • Ensure that the device meets current safety standards.

Documentation advice

Keep all emails, receipts, and correspondence regarding the recall for your records.

Product Details

The recalled product is the Allwell Inflation Device for angiographic use, REF: IS-30-A. The affected lot numbers include I2559701, I2563344, and others. The devices were distributed worldwide.

Key Facts

  • 173,645 units recalled
  • Handle may detach during procedures
  • No reported injuries or deaths
  • Immediate cessation of use recommended
  • Contact manufacturer for further instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI: 00884450653500 /Lot: I2559701 I2563344 I2567488 I2578111 I2593681 I2593683 I2603907 I2617788 I2622059 I2628990 I2653159 I2657407 I2853633 I2887859 I2887860 I2892046 I2917191 I2921522 I2927924 I2933535 I2989185 I2989187 I3027377 I3027378 I3037369 I3085686 I3085687 I3103552 I3118248 I3118249 I3154769 I3186052 I3186054 I3186058 I3214004 I3245239 I3245240 I3248078 I3282794
Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

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