Recall archive / FDA device enforcement
S8-3 Transducer Probe — FDA record Z-2397-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- S8-3 Transducer Probe
- Reason
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Classification
- Class III
- Recalling firm
- Philips Ultrasound, Inc
- Quantity
- 171,322 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2397-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. 989605361882, 989605440752, 989605361963, 989605438401, 989605387401, 989605387421, 989605400802, 989605361961, 989605361881, 989605362004, 989605362002, 21750A, 989605362003, 989605440682; UDI: (01)00884838067806(21)B2D78M, (01)00884838067806(21)B2PXNB, (01)00884838067806(21)B2TFQK, (01)00884838067806(21)B2TFQL, (01)00884838067806(21)B2TGWJ, (01)00884838067806(21)B2TGWP, (01)00884838067806(21)B3FQQB, (01)00884838067806(21)B3LC7N, (01)00884838067622(21)B3KM0K, (01)00884838067929(21)B20KQ4, (01)00884838067806(21)B2PXHR, (01)00884838067806(21)B20GMQ, (01)00884838067806(21)B2H3T2, (01)00884838067806(21)B20H2W, (01)00884838067806(21)F09M9D, (01)00884838067806(21)B3LGXW, (01)00884838067806(21)B2DF83, (01)00884838067806(21)B2PXW5, (01)00884838067806(21)F070MP, (01)00884838067806(21)F0J1R9, (01)00884838067806(21)B1MWN1, (01)00884838067806(21)B1MWQ5, (01)00884838067806(21)B27J9L, 010088483806780621F0FGBV, N/A, (01)00884838067806(21)B2D8JJ, (01)00884838067929(21)B24R5L, (01)00884838067806(21)B27PJL, (01)00884838067806(21)B1MWN0, (01)00884838067806(21)F0J9KW, (01)00884838067806(21)B2H4DL, (01)00884838067806(21)F0595D, (01)00884838067806(21)B40R7D, N/A, (01)00884838067806(21)F0L03V, (01)00884838067806(21)F0BPZP, (01)00884838067806(21)B24JJM, (01)00884838067806(21)B27R2N, (01)00884838067806(21)B2D78D, (01)00884838067806(21)B2D7RV, (01)00884838067806(21)B2D7V5, N/A, (01)00884838067806(21)B2H6RB, (01)00884838067806(21)B1RJTM, (01)00884838067806(21)F0HL8B, (01)00884838067806(21)F0HTF1, (01)00884838067806(21)B1N43T, N/A, (01)00884838067806(21)B2H4M3, (01)00884838067806(21)B1MW3P, (01)00884838067806(21)F08XR7, (01)00884838067806(21)F0HYKV, 010088483806780621F0G0FG, (01)00884838067806(21)B1MV6Z, (01)00884838067806(21)B1MV82, (01)00884838067806(21)B1MV8C, (01)00884838067622(21)B287Q3, (01)00884838067806(21)B2PTM2, (01)00884838067806(21)B1JWL7, N/A, (01)00884838067806(21)B1WVWQ, (01)00884838067806(21)B1WWJ4, (01)00884838067806(21)B1WX52, (01)00884838067806(21)B1WX5K, (01)00884838067806(21)B2DC9C, (01)00884838067806(21)B2PN7J, (01)00884838067806(21)F0JG6G, (01)00884838067806(21)F0DZWB, (01)00884838067806(21)F0F6M5, (01)00884838067806(21)F0H47P, (01)00884838067929(21)B2GZL2, N/A, (01)00884838067806(21)F08M68, (01)00884838067806(21)B2DCK5, (01)00884838067929(21)B20F7R, N/A, (01)00884838067806(21)B1WXH6, (01)00884838067806(21)B20F4C, (01)00884838067806(21)B20F76, N/A, N/A, (01)00884838067929(21)B20H54, N/A, (01)00884838067806(21)B1WWFV, N/A, N/A, N/A, (01)00884838067806(21)B2H7KN, (01)00884838067806(21)F0B5P3, N/A, (01)00884838067806(21)B24G9W, (01)00884838067806(21)B27PN0, N/A, (01)00884838067929(21)B2PTK7, (01)00884838067806(21)F0FM7R, (01)00884838067806(21)F09JR8, N/A, (01)00884838067806(21)B27HHK, (01)00884838067806(21)B27J8Y, (01)00884838067806(21)B27JWR, (01)00884838067806(21)B27QKH, N/A, (01)00884838067806(21)B3XC3V, (01)00884838067806(21)F0BWB5, (01)00884838067929(21)B24G4Q, (01)00884838067929(21)B1MWCC, (01)00884838067806(21)B20L19, (01)00884838067806(21)B1WWBY, (01)00884838067806(21)F0FHYX, (01)00884838067929(21)B3X88P, N/A, (01)00884838067806(21)B1RMK0, (01)00884838067929(21)B2PQ7N, N/A, (01)00884838067806(21)B2DBZ2, (01)00884838067806(21)B2DCHQ, (01)00884838067806(21)B2DCQ4, (01)00884838067806(21)B24RRM, (01)00884838067806(21)B1MVR9, (01)00884838067806(21)B20GHF, N/A, (01)00884838067806(21)B1JWQ3, (01)00884838067806(21)B2DFFR, (01)00884838067929(21)B20F5B, N/A, N/A, N/A, (01)00884838067806(21)B2DF24, (01)00884838067806(21)B24GJB, (01)00884838067806(21)B24GLW, (01)00884838067806(21)B24GN8, (01)00884838067806(21)B2D86B, (01)00884838067622(21)B2C47P, (01)00884838067806(21)B27PTR, (01)00884838067806(21)B3ZNV1, (01)00884838067806(21)B40QJN, (01)00884838067806(21)B40QW0, (01)00884838067806(21)B40QWB, (01)00884838067806(21)B40R21, (01)00884838067806(21)B40RCY, (01)00884838067806(21)B40XVM, (01)00884838067806(21)B40XVR, N/A, N/A, N/A, N/A, N/A, (01)00884838067806(21)B2DCFL, (01)00884838067622(21)B1F3GL, (01)00884838067806(21)B1MV62, (01)00884838067806(21)B40QND, (01)00884838067806(21)F07DVQ, (01)00884838067806(21)F07K6T, (01)00884838067806(21)B2PYCJ, (01)00884838067806(21)B2TRZZ, (01)00884838067806(21)B2DF22, (01)00884838067806(21)B2DFQH, (01)00884838067806(21)B2GZMH, N/A, (01)00884838067806(21)B2PV71, (01)00884838067806(21)B27JCG, (01)00884838067806(21)B3FR5H, (01)00884838067806(21)B1N0F1, (01)00884838067806(21)B2PNBM, N/A, (01)00884838067806(21)B32RK6, (01)00884838067806(21)B1WWG3, (01)00884838067806(21)B24JL6, (01)00884838067806(21)B1RF80, (01)00884838067929(21)B1RMXV, (01)00884838067929(21)B2ZLFJ, N/A, N/A, (01)00884838067806(21)B24JQ0, (01)00884838067806(21)B2H3XG, (01)00884838067806(21)B2H429, (01)00884838067806(21)B2H441, (01)00884838067806(21)B2H7B2, (01)00884838067806(21)B3X7R4, (01)00884838067806(21)B3XBM0, (01)00884838067806(21)B1X21Z, (01)00884838067806(21)B1X2FC, (01)00884838067806(21)B20DR6, N/A, (01)00884838067806(21)B20KHW, (01)00884838067806(21)B1MWG8, (01)00884838067806(21)B27R0J, (01)00884838067806(21)B1RRB8, (01)00884838067806(21)B2PTFV, (01)00884838067806(21)B39R49, (01)00884838067806(21)B27R01, (01)00884838067806(21)B20L32, N/A, N/A, N/A, (01)00884838067806(21)B1RMZG, (01)00884838067806(21)B1WTT3, (01)00884838067806(21)B1WXHK, (01)00884838067806(21)B1X1ZC, (01)00884838067806(21)B27T1L, (01)00884838067806(21)B1X2B8, N/A, (01)00884838067806(21)B20L1D, N/A, (01)00884838067806(21)B24GV4, N/A, (01)00884838067806(21)B1RJMB, (01)00884838067806(21)B2ZRQX, (01)00884838067806(21)B24GDR, (01)00884838067806(21)B1MV69, N/A, (01)00884838067806(21)B1JWHM, (01)00884838067806(21)B27JWP, (01)00884838067806(21)F09G0Z, (01)00884838067806(21)B2DF80, (01)00884838067806(21)B1JWX7, (01)00884838067806(21)B1RR7F, (01)00884838067806(21)B2ZR64, (01)00884838067806(21)B27K0P, (01)00884838067806(21)B27JLF, (01)00884838067806(21)B27JRB, (01)00884838067806(21)B2H8TQ, (01)00884838067806(21)B2PN4K, (01)00884838067806(21)B2PN79, (01)00884838067806(21)B1X2NP, (01)00884838067806(21)B2D82G, (01)00884838067806(21)B2DBYQ, (01)00884838067806(21)F07YKD, (01)00884838067806(21)B32RWG, (01)00884838067806(21)B40M4Z, (01)00884838067806(21)B1MWQ7, (01)00884838067806(21)B20DRN, (01)00884838067929(21)B20H5Y, (01)00884838067806(21)B1MV2Z, (01)00884838067806(21)B2H423, (01)00884838067806(21)B1WV3Q, (01)00884838067806(21)B1WV9X, (01)00884838067806(21)B1WVC0, N/A, (01)00884838067806(21)B1X2N6, (01)00884838067929(21)B1N083, N/A, (01)00884838067806(21)B24GN3, (01)00884838067806(21)B27HCW, (01)00884838067806(21)B20DZX, (01)00884838067806(21)B2PY1R, N/A, (01)00884838067806(21)B1RKCT, (01)00884838067806(21)B1JW6B, (01)00884838067806(21)B2H4DD, (01)00884838067806(21)B3W2P3, (01)00884838067806(21)F08W5X, (01)00884838067929(21)B1MVB1, (01)00884838067806(21)B20KPF, (01)00884838067806(21)B2DDY3, (01)00884838067806(21)B3FQXX, N/A, (01)00884838067806(21)B3FTL8, (01)00884838067806(21)F0BCX2, (01)00884838067929(21)B24RWC, (01)00884838067806(21)B1X2JF, N/A, N/A, (01)00884838067806(21)B1RMKV, (01)00884838067806(21)B3HW54, (01)00884838067806(21)B1RMQJ, (01)00884838067929(21)B2DFPX, (01)00884838067806(21)B2D7RQ, (01)00884838067806(21)B35F58, N/A, N/A, N/A, (01)00884838067929(21)B2TFY0, (01)00884838067806(21)B3YWTX, (01)00884838067806(21)B2H7LN, (01)00884838067806(21)B2PN7L, (01)00884838067806(21)B2DCFT, (01)00884838067806(21)B3Q4B8, (01)00884838067622(21)B1NMNB, (01)00884838067806(21)B24GZL, (01)00884838067806(21)B3Y23K, (01)00884838067806(21)B27J1K, (01)00884838067806(21)B27J67, (01)00884838067806(21)B27J6G, (01)00884838067806(21)B1N0QC, (01)00884838067806(21)B27JBH, (01)00884838067806(21)F08XQB, (01)00884838067929(21)B2TRNC, N/A, (01)00884838067929(21)B1WWLG, (01)00884838067929(21)B24RNX, (01)00884838067929(21)B2GZL3, (01)00884838067929(21)B2TFY3, (01)00884838067806(21)B40NBD, (01)00884838067806(21)B27QPY, (01)00884838067929(21)B24GC3, (01)00884838067806(21)B20KHV, (01)00884838067806(21)B2DCN6, (01)00884838067806(21)F0F1L2, N/A, N/A, (01)00884838067806(21)F0F8LP, (01)00884838067806(21)B20DPJ, N/A, (01)00884838061422(21)B2BP2T, N/A, (01)00884838067806(21)B1WV4R, (01)00884838067806(21)B3Y78Z, (01)00884838067806(21)B3YNLT, (01)00884838067806(21)F0H47B, (01)00884838067806(21)B3HRR6, (01)00884838067806(21)B1N0CW, (01)00884838067806(21)B1WWRH, (01)00884838067806(21)B32RML, (01)00884838067806(21)B32RMR, (01)00884838067806(21)F08PP1, (01)00884838067929(21)B1D9QN, (01)00884838067806(21)B1X2NY, (01)00884838067806(21)B27QJT, (01)00884838067806(21)B2ZKG9, N/A, (01)00884838067806(21)F0JDMF, (01)00884838067806(21)B1RQRP, (01)00884838067929(21)B2H8Z0, (01)00884838067929(21)B3HVHF, (01)00884838067929(21)B3YVHB, N/A, N/A, N/A, N/A, (01)00884838067806(21)B20KWR, (01)00884838067806(21)B20L8Y, N/A, (01)00884838067929(21)B1RJY0, (01)00884838067929(21)B35LHX, (01)00884838067929(21)B3HVHN, (01)00884838067622(21)B287RH, (01)00884838067806(21)B3ZN1J, (01)00884838067806(21)B2D7B9, (01)00884838067929(21)B1WWLL, N/A, (01)00884838067806(21)B24GWK, (01)00884838067806(21)B27QMC, N/A, N/A, (01)00884838067806(21)B1RDLX, (01)00884838067806(21)B35FKX, (01)00884838067806(21)B1RJMP, (01)00884838067806(21)B20KVC, (01)00884838067806(21)B27JL9, (01)00884838067806(21)B27JLB, (01)00884838067806(21)B3XVDB, (01)00884838067806(21)B3Z5PL, (01)00884838067806(21)B40LKX, (01)00884838067806(21)B1DG0V, (01)00884838067806(21)B24J2B, N/A, (01)00884838067806(21)B1MV0P, (01)00884838067806(21)B2ZKC2, (01)00884838067806(21)B2ZRQR, (01)00884838067806(21)B2D749, (01)00884838067806(21)B2D75L, (01)00884838067806(21)B24QJF, (01)00884838067806(21)B40Z9Y, N/A, (01)00884838067806(21)B2H4FF, (01)00884838067806(21)B2PTNR, (01)00884838067806(21)B2ZLD6, N/A, N/A, (01)00884838067806(21)B24QD3, (01)00884838067806(21)B1JWDT, (01)00884838067806(21)B27HCX, (01)00884838067806(21)B1MV5K, (01)00884838067806(21)B27QHQ, N/A, N/A, (01)00884838067806(21)B3HRQB, (01)00884838067806(21)B3W21R, (01)00884838067622(21)B288HD, (01)00884838067929(21)B2GZHV, N/A, (01)00884838067806(21)B20DPM, N/A, (01)00884838067806(21)F0B14N, (01)00884838067806(21)B20DYV, (01)00884838067806(21)B3LC5V, (01)00884838067929(21)B3HQBK, (01)00884838067806(21)B1MV2V, (01)00884838067806(21)B2D86H, (01)00884838067806(21)B2PXN7, (01)00884838067806(21)B2D7YX, (01)00884838067806(21)B35LB5, (01)00884838067806(21)B3X6JT, (01)00884838067806(21)B3YMDH, (01)00884838067806(21)F09M8Y, (01)00884838067806(21)B2DCFG, N/A, (01)00884838067806(21)B20F48, (01)00884838067806(21)B20GGY, (01)00884838067806(21)B20GTB, N/A, (01)00884838067806(21)B2D7VB, (01)00884838067806(21)B1MVDJ, (01)00884838067929(21)B24J6B, (01)00884838067806(21)B1N07Y, (01)00884838067806(21)B3Y1DC, (01)00884838067806(21)B1RJKN, (01)00884838067806(21)B1MWKQ, (01)00884838067806(21)B1MWN2, (01)00884838067806(21)B20L14, N/A, (01)00884838067806(21)B2PMP6, (01)00884838067806(21)F0H47H, (01)00884838067806(21)B20DGF, (01)00884838067806(21)B27J9K, (01)00884838067806(21)B20H38, N/A, (01)00884838067806(21)B1RDLR, (01)00884838067806(21)B2DF86, (01)00884838067806(21)B3XVJ3, N/A, (01)00884838067806(21)B32QYM, (01)00884838067806(21)F0F1KK, (01)00884838067806(21)B1WWH4, (01)00884838067806(21)B20Q3N, N/A, (01)00884838067806(21)B1RJHB, N/A, (01)00884838067806(21)B2H0WP, (01)00884838067806(21)B3PXL2, (01)00884838067806(21)B27TDF, (01)00884838067806(21)B40QPQ, (01)00884838067806(21)B40QPT, (01)00884838067806(21)B40R20, (01)00884838067806(21)B40T3P, (01)00884838067806(21)F07GJ7, N/A, N/A, (01)00884838067806(21)B24G86, (01)00884838067806(21)B1WWRQ, (01)00884838067806(21)B1WWWH, (01)00884838067806(21)B40QWC, (01)00884838067806(21)B1MWM9, (01)00884838067806(21)B1MV0W, (01)00884838067806(21)B27PH9, (01)00884838067806(21)B27QHT, (01)00884838067806(21)B27QHV, (01)00884838067806(21)B2PY26, (01)00884838067806(21)B40QNP, (01)00884838067806(21)B40R27, (01)00884838067806(21)B2DCGH, (01)00884838067806(21)B2DCK2, (01)00884838067806(21)B3HV1J, (01)00884838067806(21)B3HY69, (01)00884838067806(21)B2H1D8, (01)00884838067806(21)B20KWW, (01)00884838067806(21)B1JWC0, (01)00884838067806(21)B1JWHL, (01)00884838067806(21)B1JWPY, ... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 3, 2025
- Center classification date
- Aug 22, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.