Reported Jan 28, 2026 · Ongoing
Allwell Angioplasty Pack REF: IS-30-B1/B
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 Angioplasty Pack REFIS-30-B1/B
- Lot codes and dates
- UDI00884450653388/
- Lot
I2563105I2563106I2565007I2598114I2598131I2607891I2612499I2618005I2623057I2632527I2632528I2639728I2661908I2669772I2669774I2827091I2827094I2844360I2844361I2897482I2897483I2897484I2897485I2924663I2972425I2972426I2972427I2972428I2999054I3014683I3030198I3048363I3055799I3080949I3089230I3099150I3110034I3129711I3129712I3161408I3268359I3268361I3268362
- Amount recalled
- 328000 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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