Recall Z-1124-2026— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Allwell Inflation Device, for angiographic use REF: IS-30-A. Reason: Inflation device handle may detach from the syringe during procedure..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-04
- Firm location
- South Jordan, UT, United States
Product description
Allwell Inflation Device, for angiographic use REF: IS-30-A
Reason for recall
Inflation device handle may detach from the syringe during procedure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.