Philips Ultrasound, Inc: Medical Device Recall in 2025 - (Recall #: Z-2385-2025)

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:

Mini Multi TEE Transducer Probe

Product Classification:

Class III

Date Initiated: July 3, 2025

Date Posted: September 3, 2025

Recall Number: Z-2385-2025

Event ID: 97217

Reason for Recall:

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Status: Ongoing

Product Quantity: 171,322 units

Code Information:

Model No. 989605439242, 21381A; UDI: (01)00884838067547(21)B0DTV4, (01)00884838067547(21)B01639, (01)00884838067547(21)B06NT3; Serial No. 0341YT, 0319CQ, 028NZW, B0RF1J, B0F31L, B0DTV4, B0C9XR, 02H0L8, B0KYGV, B01639, B06NT3, 03C68B, 03C8CW.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated