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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Merit Medical Systems
- Product type
- Inflation Device
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 4, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check if your device is from the affected lot numbers listed in the recall notice.
- Inspect the handle and syringe connection for any signs of wear or detachment.
- 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.
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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
- Handle may detach during procedures
- No reported injuries or deaths
- Immediate cessation of use recommended
- Contact manufacturer for further instructions
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Safety Guide
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