Merit Medical recalls Allwell Inflation Devices (REF: IS-30-A) for angiographic use due to risk of handle detaching during procedures. Affected units have specific UDI and lot numbers listed in the recall.
Inflation device handle may detach from the syringe during procedure.
Merit Medical is recalling Allwell Inflation Devices used in angiography because the handle might detach during procedures. This could lead to complications if the device becomes dislodged while being used.
The inflation device handle can detach from the syringe during medical procedures. If this happens, the device may become dislodged, potentially causing complications for the patient or the medical team.
Healthcare professionals using the Allwell Inflation Device for angiographic procedures are most at risk. Patients receiving these devices during procedures may also be affected.
Check for the product name 'Allwell Inflation Device' with the reference number IS-30-A. Affected units have specific UDI and lot numbers listed in the recall notice.
Inspect the device to ensure the handle remains securely attached to the syringe before use.
The recall number is REF: IS-30-A.
The recall affects healthcare facilities using the Allwell Inflation Device for angiographic procedures with the specific UDI and lot numbers listed.
Check the device for the reference number IS-30-A and look for the specific UDI and lot numbers listed in the recall notice.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1124-2026 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1124-2026 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.