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
- Angioplasty Pack
- Model numbers
- UDI:00884450653388/ Lot: I2563105 I2563106 I2565007 I2598114 I2598131 I2607891 I2612499 I2618005 I2623057 I2632527 I2632528 I2639728 I2661908 I2669772 I2669774 I2827091 I2827094 I2844360 I2844361 I2897482 I2897483 I2897484 I2897485 I2924663 I2972425 I2972426 I2972427 I2972428 I2999054 I3014683 I3030198 I3048363 I3055799 I3080949 I3089230 I3099150 I3110034 I3129711 I3129712 I3161408 I3268359 I3268361 I3268362
- 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 Angioplasty Pack is a medical device used during angioplasty procedures to inflate balloons or stents. Healthcare providers use it to treat narrowed arteries and improve blood flow. Patients rely on this device for essential cardiovascular procedures.
Why This Is Dangerous
The handle of the inflation device may detach from the syringe during use, which can lead to complications during medical procedures. This defect compromises patient safety and may affect the efficacy of the treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must cease using the affected packs, which could disrupt ongoing medical treatments. The high risk of detachment raises concerns for patient safety and may necessitate alternative treatments.
Practical Guidance
How to identify if yours is affected
- Locate the packaging of the angioplasty pack.
- Check for the UDI number: 00884450653388.
- Confirm if the lot number matches any listed in the recall.
Where to find product info
The UDI code can typically be found on the product packaging or the instruction manual.
What timeline to expect
Refund or replacement processing can take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Reach out to FDA for further assistance.
- Consider consulting a legal advisor if necessary.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for FDA certification on medical products.
- Consult with healthcare providers about device reliability.
Documentation advice
Keep a record of your purchase, any communications about the recall, and photographs of the product.
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Product Details
The recalled product is the Allwell Angioplasty Pack, REF: IS-30-B1/B. It has been distributed globally, including in all U.S. states and several countries. The devices were sold under multiple model numbers including UDI: 00884450653388.
Key Facts
- Risk of inflation device handle detaching
- Contact manufacturer for instructions
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