Philips Ultrasound, Inc: Medical Device Recall in 2025 - (Recall #: Z-2391-2025)

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:

S4-1 Transducer Probe

Product Classification:

Class III

Date Initiated: July 3, 2025
Date Posted: September 3, 2025
Recall Number: Z-2391-2025
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. 989605389271, 989605389272, 989605364993; UDI: (01)00884838061415(21)B30VBN, (01)00884838061415(21)F0954W, (01)00884838061415(21)B3WCRT, (01)00884838061415(21)B1WDKX, (01)00884838061415(21)B1WDNQ, (01)00884838064584(21)B13HXX, (01)00884838064584(21)B1MQDX, (01)00884838064584(21)B23LRM, (01)00884838064584(21)B23LRT, (01)00884838061415(21)B1X9Z3, (01)00884838064584(21)B12QQ8, (01)00884838061415(21)B27XB2, (01)00884838061415(21)B307TT, 010088483806141521F01WFB, (01)00884838061415(21)B30THD, (01)00884838061415(21)B1TKB3, (01)00884838061415(21)F08XDL, (01)00884838061415(21)F0B7L5, (01)00884838061415(21)F048QQ, (01)00884838061415(21)F0665R; Serial No. B30VBN, B1GPT4, B1NW75, F0954W, B3WCRT, B1WDKX, B1WDNQ, B13HXX, B1MQDX, B23LRM, B23LRT, B1X9Z3, B12QQ8, B27XB2, B307TT, F01WFB, B1KXRP, B30THD, B1TKB3, F08XDL, F0B7L5, F048QQ, F0665R.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated