Merit Medical Systems, Inc. 2026-01-28 Health serious FDA
Health · FDA · Recall #FDA-Z-1124-2026
Allwell Inflation Device, for angiographic use REF: IS-30-A Recall
Issued January 28, 2026 · Merit Medical Systems, Inc.
In January 2026, Merit Medical Systems, Inc. recalled the Allwell Inflation Device, for angiographic use REF: IS-30-A, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Inflation device handle may detach from the syringe during procedure.
What you should do
- 1 Stop using Allwell Inflation Device, for angiographic use REF: IS-30-A right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Merit Medical Systems, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Merit Medical Systems, Inc.
- Category
- Health
- Recall date
- January 28, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, M
- Recall number
- FDA-Z-1124-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Merit Medical Systems, Inc. has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.