BIB recallZ-1754-2025 · Numed Inc · initiated Apr 21, 2025
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Numed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1754-2025
- Status
- Terminated
- Initiated by the company
- Apr 21, 2025
- Posted by the FDA
- May 13, 2025
- Recalling firm
- Numed Inc
- Quantity
- 4 units
- Product code
- NVM
- FDA submissions
- K050857
- Distribution
- US distribution to Pennsylvania.
Product description
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Code information (models, lots, serial 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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BIB® 614396B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 recall0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K050857 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BIB® 614440B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614444B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614445B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614446B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614451B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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