Philips Ultrasound, Inc: Medical Device Recall in 2025 - (Recall #: Z-2388-2025)

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:

OMNI III TEE Transducer Probe

Product Classification:

Class III

Date Initiated: July 3, 2025

Date Posted: September 3, 2025

Recall Number: Z-2388-2025

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. 989605440702, 21378A; UDI: (01)00884838067585(21)B1CW9T, (01)00884838067585(21)B201MC, (01)00884838067585(21)B1CW9Q, (01)00884838067585(21)B1MK5D, (01)00884838067585(21)B1MK5X, (01)00884838067585(21)B198WH, (01)00884838067585(21)B1MKD9, (01)00884838067585(21)B198V3, (01)00884838067585(21)B201JF, (01)00884838067585(21)B201Q0, (01)00884838067585(21)B1991G, (01)00884838067585(21)B17X87, (01)00884838067585(21)B1MKC3, (01)00884838067585(21)B201QF, (01)00884838067585(21)B2FW9F, (01)00884838067585(21)B198VV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)B2FW8Z, (01)00884838067585(21)B201N8, (01)00884838067585(21)B34R1B, (01)00884838067585(21)B05DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)B201K2, (01)00884838067585(21)B198Z2, (01)00884838067585(21)B1991B; Serial No. B1CW9T, 02Y7HM, 02VTGK, B201MC, B1CW9Q, 037CHG, 03G8B1, 03G0BB, B1MK5D, B1MK5X, 02WH6F, 033ZLX, 033W7Z, 03CWJM, 02QK2L, B198WH, 038MJ6, 037F68, B1MKD9, 038GL7, 0344C9, B04LK2, B1991F, B198V3, B1FTDM, 0341PJ, B201JF, 037HLM, 035R8K, B201Q0, B1FTFZ, 02QCRQ, B1991G, 02JL01, B1MK2K, B17X87, 02JJ0T, 031LC8, B1MKC3, B201QF, B1990H, B19918, 03FZXM, 039JWQ, 035PYK, 03436F, B2FW9F, 039PCB, B1MK2F, 031HN7, 02P8GV, B198VV, 02H0WW, 039HQ2, B07FFB, B2FW8Z, 02WJBB, B201N8, 02VP8P, B34R1B, 02YK1Q, B19900, 039Q2L, B05DX2, 02YCFD, 02WCTB, 039PC3, 035V3H, B0LYR8, B201K2, 02PDT7, 032MLN, 035P8R, 038LT2, B0M32G, 03G4GG, B0X7N7, 038HV5, 032MMK, 02QGKV, 028PNR, B198Z2, 032FKW, B198ZV, 03GZ12, 03191G, B1991B, B198ZK, 03C04R, 030228.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated