Numed Inc 2025-05-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1754-2025
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Recall
Issued May 21, 2025 · Numed Inc
In May 2025, Numed Inc recalled the BIB Balloon in Balloon Dilatation Catheter. Model Number: 420, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Numed Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Numed Inc
- Category
- Health
- Recall date
- May 21, 2025
- Units affected
- Not reported
- Sold at
- US distribution to Pennsylvania.
- Recall number
- FDA-Z-1754-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Numed Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.