FDA Medical devices recall ·
BIB Balloon in Balloon Dilatation Catheter recall
- Recall number
- Z-1754-2025
- Date
- (initiated April 21, 2025)
- Company / brand
- Numed Inc
2880 Main Street /Rt 11b, Hopkinton, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 4 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005.
Distribution
US distribution to Pennsylvania.
States: Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1754-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.