Merit Medical recalls Allwell Angioplasty Packs with REF: IS-30-B1/B due to risk of handle detaching during procedures. Affected units include specific lot numbers. Consumers should contact Merit Medical for details.
Inflation device handle may detach from the syringe during procedure.
Merit Medical is recalling Allwell Angioplasty Packs with REF: IS-30-B1/B because the inflation device handle might detach during procedures. This could lead to serious injury if the device is not properly secured.
The inflation device handle can detach from the syringe during medical procedures. This could cause the device to become unstable or malfunction, potentially leading to injury if not properly secured.
Healthcare professionals using the Allwell Angioplasty Packs for medical procedures are most at risk. Patients receiving these procedures may also be affected if the device detaches.
Check for the product reference number IS-30-B1/B on the packaging. Affected units include specific lot numbers listed in the recall notice.
Look for the reference number IS-30-B1/B and specific lot numbers listed in the recall notice.
The inflation device handle may detach from the syringe during procedures, which could lead to serious injury.
Check for the reference number IS-30-B1/B and specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Merit Medical directly for instructions.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1129-2026 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1129-2026 from Merit Medical Systems. 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.
