FDA Medical Device Recalls (openFDA)
Numed Inc: BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
- Recall number
- Z-1754-2025
- Recalling firm
- Numed Inc
- Product
- BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
- Status
- Terminated
- Initiated
- 2025-04-21
- Posted
- 2025-05-13
- Terminated
- 2025-12-17
- Reason
- 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.
- Root cause
- Mixed-up of materials/components
- Action
- NuMED sent a "URGENT: MEDICAL DEVICE RECALL" letter dated 4/21/2025 via email on 4/21/2025 to their single customer. The customer was instructed to immediately return the affected units as soon as possible. If you have any questions or concerns, please contact Regulatory Affairs Manager at (315) 328-4491, or via email at nlaflesh@numedusa.com.
- Quantity
- 4 units
- Distribution
- US distribution to Pennsylvania.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K050857"]
- PMA numbers
- not on file
- Product code
- NVM
- Firm FEI
- 1318694
- Firm city
- Hopkinton
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28