BIB Balloon Catheter (Numed) – Labeling Error (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Brand
Numed Inc
Lot Codes / Batch 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.
Products Sold
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.
Numed Inc is recalling BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 due to Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer ball. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PA
Page updated: Jan 10, 2026