Data Foundry

Medical device recalls 2025

eL18-4 Transducer Probe — Class III medical device recall Z-2369-2025

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 numberZ-2369-2025
Product typeMedical device
ClassificationClass III
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Ultrasound, Inc, Reedsville, PA, United States
Recall initiated2025-07-03
Classified2025-08-22
Reported by FDA2025-09-03
DistributedNationwide (US)
Quantity171,322 units
UPC / GTIN / UDI-DI00884838061354, 00884838061507, 00884838061583, 00884838070806, 00884838070813
Serial numbersB1YT21, B1YT23, B2319Q, B231KT, B23VCY, B23VFY, B23VG9, B23VGP, B23VJH, B23VM3, B23VM4, B23VNL, B23VNN, B23VNR, B23VNT, B23VQ4, B23VQC, B23VRQ, B23VV2, B23VV4, B23VVK, B23VVN, B23VVV, B23VVZ, B23VW1 and 475 more
Model numbers989605391092, 989605409562, 989605412062, 989605431531, 989605456291

Product

eL18-4 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-2369-2025. 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.