Philips L8-4 Transducer — Class II medical device recall Z-2056-2025
Ongoing recall by Philips Ultrasound, Inc, reported 2025-07-09, distributed nationwide. Ultrasound transducer devices were refurbished beyond their useful life.
| Recall number | Z-2056-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc, Reedsville, PA, United States |
| Recall initiated | 2025-05-28 |
| Classified | 2025-07-02 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, 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 |
| Quantity | 5,230 units |
| UPC / GTIN / UDI-DI | 00884838067684 |
| Serial numbers | 02CCM5, 02DLVR, 02FWNQ, 02H2JM, 02H34T, 02HJDK, 02JC66, 02KKVB, 02KKZT, 02KLBP, 02KMFZ, 02KMKK, 02LT6G, 02LTKK, 02NK5J, 02RTF9, 02V016, 02V8VD, 037Z2B, 038XYV, 03BPVM, 03H7GL, B0LZNN |
| Model numbers | 989605440811, 989605440812 |
Product
Philips L8-4 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-2056-2025. 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.