Allwell Inflation Device, for angiographic use REF: IS-30-A
Pending LLM rewrite. Source: FDA_DEVICE Z-1124-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Inflation device handle may detach from the syringe during procedure.
The recalled product
- Product
- Allwell Inflation Device, for angiographic use REF: IS-30-A
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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