Medium risk Drugs & MedicationsClass II

Merit Medical Systems, Inc. Recall

Allwell Inflation Device, for angiographic use REF: IS-30-A

Updated December 4, 2025

Merit Medical Systems, Inc. is recalling Allwell Inflation Device, for angiographic use REF: IS-30-A. Hazard: Inflation device handle may detach from the syringe during procedure.

Is the Merit Medical Systems, Inc. recalled? Yes. This product was recalled by FDA on December 4, 2025. Details below.

What is recalled

Allwell Inflation Device, for angiographic use REF: IS-30-A

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

Inflation device handle may detach from the syringe during procedure.

Brands affected

Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1124-2026
Classification
Class II
Recalled
December 4, 2025
Read the official notice

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