Data Foundry

Medical device recalls 2025

Philips 3D9-3v Transducer — Class II medical device recall Z-2048-2025

Ongoing recall by Philips Ultrasound, Inc, reported 2025-07-09, distributed nationwide. Ultrasound transducer devices were refurbished beyond their useful life.

Recall numberZ-2048-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Ultrasound, Inc, Reedsville, PA, United States
Recall initiated2025-05-28
Classified2025-07-02
Reported by FDA2025-07-09
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, LB, LK, LU, LV, MA, MX, MY, NI, NL, NZ, OM, PH, PL, PT, RO, SA, SE, SG, TH, TW, VE, VN, ZA
Quantity5,230 units
UPC / GTIN / UDI-DI00884838061453, 00884838061545, 00884838067707, 00989605395622
Serial numbers02LYV3, 02QPN8, 02TW66, 02V8H4, 02VLBF, 02W497, 02W7LR, 02WBMV, 02WBN2, 02XWQY, 02Y4D4, 02Z2VX, 02Z6TY, 02ZQPT, 030G4C, 030XZN, 031318, 031P2Y, 03201R, 0323K1, 0334YJ, 03369B, 033G84, 033QRP, 034GJZ and 89 more
Model numbers989605325181, 989605395622, 989605415032, 989605440831, 989605440832

Product

Philips 3D9-3v Transducer.

Reason for recall

Ultrasound transducer devices were refurbished beyond their useful life.

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-2048-2025. 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.