Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Numed Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-1754-2025 — Numed Inc Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Hello, I own a Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 that is covered by recall Z-1754-2025 from Numed Inc. 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.
