OMNI III TEE Transducer Probe — Class III medical device recall Z-2388-2025
Ongoing recall by Philips Ultrasound, Inc, reported 2025-09-03, distributed nationwide. To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
| Recall number | Z-2388-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc, Reedsville, PA, United States |
| Recall initiated | 2025-07-03 |
| Classified | 2025-08-22 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 171,322 units |
| UPC / GTIN / UDI-DI | 00884838067585 |
| Serial numbers | 028PNR, 02H0WW, 02JJ0T, 02JL01, 02P8GV, 02PDT7, 02QCRQ, 02QGKV, 02QK2L, 02VP8P, 02VTGK, 02WCTB, 02WH6F, 02WJBB, 02Y7HM, 02YCFD, 02YK1Q, 030228, 03191G, 031HN7, 031LC8, 032FKW, 032MLN, 032MMK, 033W7Z and 65 more |
| Model numbers | 21378A, 989605440702 |
Product
OMNI III TEE Transducer Probe
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2388-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.