Centerline Biomedical Inc: Medical Device Recall in 2025 - (Recall #: Z-1760-2025)

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:

Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

Product Classification:

Class I

Date Initiated: April 11, 2025

Date Posted: May 28, 2025

Recall Number: Z-1760-2025

Event ID: 96697

Reason for Recall:

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Status: Ongoing

Product Quantity: 80 units

Code Information:

UDI/DI 00843152102037, Lot Number 2404-2005

Distribution Pattern:

US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee

Voluntary or Mandated:

Voluntary: Firm initiated