Numed Inc: Medical Device Recall in 2025 - (Recall #: Z-1754-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

Product Classification:

Class II

Date Initiated: April 21, 2025

Date Posted: May 21, 2025

Recall Number: Z-1754-2025

Event ID: 96734

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4 units

Code Information:

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 Pattern:

US distribution to Pennsylvania.

Voluntary or Mandated:

Voluntary: Firm initiated