The Recall Desk
Severity pendingFDA (Devices)·Z-2388-2025·Announced 2025-09-03

OMNI III TEE Transducer Probe

Pending LLM rewrite. Source: FDA_DEVICE Z-2388-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

Product
OMNI III TEE Transducer Probe
Manufacturer
Philips Ultrasound, Inc
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category