Reported Jan 28, 2026 · Ongoing
Allwell Inflation Device, for angiographic use REF: IS-30-A
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Allwell Inflation Device
- for angiographic use REFIS-30-A
- Lot codes and dates
- UDI00884450653500 /Lot:
I2559701I2563344I2567488I2578111I2593681I2593683I2603907I2617788I2622059I2628990I2653159I2657407I2853633I2887859I2887860I2892046I2917191I2921522I2927924I2933535I2989185I2989187I3027377I3027378I3037369I3085686I3085687I3103552I3118248I3118249I3154769I3186052I3186054I3186058I3214004I3245239I3245240I3248078I3282794
- UDI00884450653500 /Lot:
- Amount recalled
- 173,645 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Inflation device handle may detach from the syringe during procedure.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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