Recall archive / FDA device enforcement
S5-2 Transducer Probe — FDA record Z-2394-2025
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
- S5-2 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-2394-2025
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. 989605412082, 989605440682, 989605388091, 21314A, 989605438581, 989605361871, 989605412081, 989605961871, 989605391922, 989605387852, 989605440752, 989605412052, 989605361892, 989605384711, 989605400802; UDI: (01)00884838061637(21)B268VV, (01)00884838061637(21)B2BK4Q, (01)00884838061637(21)B2XV6D, (01)00884838061637(21)B2XVMK, (01)00884838061637(21)B3GLNL, (01)00884838061637(21)B3H17V, (01)00884838061637(21)B3H60B, (01)00884838061637(21)B3RBBZ, (01)00884838061637(21)F00X3V, (01)00884838061637(21)F055Z3, (01)00884838061637(21)F07YX6, (01)00884838061637(21)F0DZGY, (01)00884838061637(21)F0H3M1, (01)00884838061637(21)B3NT5N, (01)00884838061637(21)B1WFML, (01)00884838067561(21)B2BJQ4, (01)00884838067561(21)B2BK64, (01)00884838061637(21)B1Q2GH, (01)00884838061637(21)B1QVY3, 010088483806163721F0G049, (01)00884838061637(21)B3DGJ9, (01)00884838061637(21)F02WHD, (01)00884838061637(21)F0CM58, (01)00884838067561(21)B3D85G, (01)00884838067561(21)F0B3B2, (01)00884838061637(21)B1KYB4, (01)00884838061637(21)B1XMHD, (01)00884838061637(21)B1YT6J, (01)00884838061637(21)B35159, (01)00884838061637(21)F02KM5, (01)00884838061637(21)F0421R, (01)00884838061637(21)F062N7, (01)00884838061637(21)F0D3RL, (01)00884838067561(21)B1837D, (01)00884838067561(21)B19576, (01)00884838061637(21)B2WWLH, (01)00884838061637(21)B3JYHQ, 010088483806163721F02BZK, (01)00884838067561(21)F0918Z, (01)00884838061637(21)B28722, (01)00884838061637(21)F0CWJD, (01)00884838061637(21)F0D9N4, (01)00884838061637(21)B1WFGX, (01)00884838061637(21)B1PBXF, (01)00884838061637(21)B29G8W, (01)00884838061637(21)B3QJBD, (01)00884838061637(21)B3QLH3, (01)00884838061637(21)F01MN2, (01)00884838061637(21)F0421N, (01)00884838061637(21)F06969, (01)00884838061637(21)F06DYK, (01)00884838061637(21)F0DL6D, (01)00884838061637(21)F0FGYM, (01)00884838061637(21)F0FHGJ, (01)00884838061637(21)F0GF2J, (01)00884838067561(21)B2FN2X, (01)00884838067561(21)B2LPDW, (01)00884838067561(21)B2NVMH, 010088483806163721F0GCFV, 010088483806163721F0GHZP, (01)00884838061637(21)B1YTKL, (01)00884838061637(21)B2XVNP, (01)00884838061637(21)F043WP, (01)00884838061637(21)F043XN, (01)00884838061637(21)F05RXQ, (01)00884838061637(21)B1VHQ1, (01)00884838061637(21)B1VHRD, (01)00884838061637(21)B2NVL3, (01)00884838061637(21)B3PKH0, (01)00884838061637(21)B3RJ13, (01)00884838061637(21)F0443K, (01)00884838061637(21)B22JFN, (01)00884838061637(21)F0CZG3, 010088483806163721F0G48C, (01)00884838061637(21)B2HV9N, (01)00884838061637(21)F0D54H, 010088483806163721F0GR80, (01)00884838067561(21)B0D24X, (01)00884838067561(21)B183G4, (01)00884838067561(21)B077DX, (01)00884838061637(21)B22K1Y, (01)00884838061637(21)B2YH3K, (01)00884838061637(21)F07C67, (01)00884838061637(21)F09Z0T, (01)00884838061637(21)B2HV9X, (01)00884838061637(21)F02KJN, (01)00884838061637(21)F0F4PG, (01)00884838061637(21)F0F4PR, (01)00884838061637(21)F0FCDB, 010088483806163721F0FYZK, 010088483806163721F0G1WN, 010088483806163721F0G2FL, (01)00884838061637(21)B1Q5XV, (01)00884838061637(21)B1Q5YQ, (01)00884838061637(21)B268W9, (01)00884838061637(21)B26VLF, (01)00884838067561(21)B0GRQN, (01)00884838067561(21)B2HV33, (01)00884838061637(21)B1NRY8, (01)00884838067561(21)B1CB0M, 010088483806163721F0G2LV, (01)00884838061637(21)F0J53X, (01)00884838067561(21)B1XMH1, (01)00884838067561(21)B2PHCQ, (01)00884838067561(21)B3F3MQ, (01)00884838061637(21)F09D7H, (01)00884838061637(21)F0JW29, (01)00884838067561(21)B268LT, (01)00884838067561(21)B268MP, (01)00884838061637(21)B31L8Y, (01)00884838061637(21)F04R2Y, (01)00884838067561(21)B1XMLH, (01)00884838061637(21)B1XM82, (01)00884838061637(21)B1XMCJ, (01)00884838061637(21)B1XMCR, 010088483806163721F0G5BZ, (01)00884838061637(21)B2BK09, (01)00884838061637(21)F05XBF, (01)00884838061637(21)B1Q5X5, (01)00884838061637(21)B1Q5YK, (01)00884838061637(21)B1BGQ2, (01)00884838061637(21)B21QFP, (01)00884838061637(21)B2BK13, (01)00884838061637(21)F082X2, (01)00884838061637(21)F03VM5, (01)00884838061637(21)B25M6Y, (01)00884838061637(21)B25M8C, (01)00884838067561(21)B01TTH, (01)00884838067561(21)B17ZMX, (01)00884838067561(21)B2YGYN, (01)00884838061637(21)B1LFRH, (01)00884838067561(21)B17ZKN, (01)00884838067561(21)B1TTN1, (01)00884838061637(21)F01BMN, (01)00884838067561(21)B077H1, (01)00884838061637(21)B20ZGV, (01)00884838061637(21)F0H74M, (01)00884838061637(21)F0HCKJ, (01)00884838061637(21)F0HCKP, (01)00884838067561(21)B1VHR7, (01)00884838067561(21)B1YT87, (01)00884838061637(21)F0096X, (01)00884838067561(21)B1TTQM, (01)00884838061637(21)F0LGTX, (01)00884838061637(21)B3HHVK, (01)00884838061637(21)F048NW, (01)00884838067561(21)B39YNQ, (01)00884838061637(21)F084FT, (01)00884838061637(21)B2NVKR, (01)00884838061637(21)B2VRYQ, (01)00884838061637(21)B3MGZJ, (01)00884838061637(21)F0GB3K, (01)00884838067561(21)B38D5T, (01)00884838067561(21)F071BG, (01)00884838061637(21)B268Q0, (01)00884838061637(21)F0D59G, (01)00884838061637(21)F0D59Q, (01)00884838061637(21)B20ZJV, (01)00884838061637(21)F01MTD, (01)00884838061637(21)F06BVW, (01)00884838061637(21)F07C6X, (01)00884838061637(21)F07JX8, (01)00884838061637(21)B1Q68K, (01)00884838061637(21)B2BK25, (01)00884838061637(21)B2BK44, (01)00884838061637(21)B2BK47, (01)00884838061637(21)B2BK4R, (01)00884838061637(21)B351JV, (01)00884838061637(21)B3604B, (01)00884838061637(21)F009YV, (01)00884838061637(21)F00BB0, (01)00884838067561(21)B1YTB3, (01)00884838061637(21)B2HW59, (01)00884838067561(21)B0FQ9F, (01)00884838067561(21)B0QK4Z, (01)00884838061637(21)B1YTHW, (01)00884838061637(21)F0H5C1, (01)00884838061637(21)F0H74F, (01)00884838061637(21)B22K5K, (01)00884838061637(21)F06J54, (01)00884838061637(21)F0D58T, (01)00884838061637(21)B2LP5Z, (01)00884838061637(21)B12VBZ, (01)00884838061637(21)F00TGH, (01)00884838061637(21)F0CCKW, (01)00884838061637(21)B1RTTQ, (01)00884838061637(21)F084F7, (01)00884838067561(21)B1BNP1, (01)00884838061637(21)B1XM6J, (01)00884838061637(21)B1XMB2, (01)00884838061637(21)B20ZD2, (01)00884838061637(21)B268P8, (01)00884838061637(21)B34MYL, (01)00884838061637(21)F0DZGX, (01)00884838067561(21)B21QBV, (01)00884838067561(21)B0GT19, (01)00884838061637(21)B2HVM3, (01)00884838061637(21)B1TTHN, (01)00884838061637(21)B3RBC6, (01)00884838061637(21)B2NWK8, (01)00884838061637(21)B3HHRW, (01)00884838061637(21)F00NB9, (01)00884838061637(21)F0D6HV, (01)00884838067561(21)B09M5G, (01)00884838067561(21)B0QNMV, (01)00884838067561(21)B1XM7G, (01)00884838067561(21)B2BK95, (01)00884838061637(21)B2RGPW, (01)00884838061637(21)B2PH6P, (01)00884838061637(21)B1Q2L9, (01)00884838067561(21)B08N1R, (01)00884838067561(21)B1TTQJ, (01)00884838061637(21)B3VDFN, (01)00884838067561(21)B1YT6C, (01)00884838067561(21)B3N1G9, (01)00884838061637(21)B1TTYM, (01)00884838061637(21)B3NK25, (01)00884838061637(21)F0CB4R, (01)00884838061637(21)F0FH82, 010088483806163721F0G6ZX, (01)00884838061637(21)F0L10L, (01)00884838061637(21)B1NRZ2, (01)00884838061637(21)B1Q2LR, (01)00884838061637(21)B1Q2PN, (01)00884838061637(21)F0FBFD, (01)00884838067561(21)B0R4YF, (01)00884838061637(21)B1Q2N9, (01)00884838067561(21)B2HVB4, (01)00884838061637(21)B2WX34, (01)00884838061637(21)F083CL, (01)00884838067561(21)B1C9TX, (01)00884838061637(21)B1L28Y, (01)00884838061637(21)B2LNTN, (01)00884838061637(21)F009GQ, (01)00884838067561(21)B20Z7V, (01)00884838067561(21)B268QC, (01)00884838067561(21)B2LPDQ, (01)00884838067561(21)B3PKKD, (01)00884838067561(21)F06LQR, (01)00884838067561(21)F081XF, (01)00884838067561(21)F08478, (01)00884838067561(21)F093R4, (01)00884838067561(21)F0B8L3, (01)00884838061637(21)B1WFFZ, (01)00884838061637(21)B1YTWH, (01)00884838061637(21)B2G6FZ, (01)00884838061637(21)B2HWHM, (01)00884838061637(21)B2LNWK, (01)00884838061637(21)B2PH95, (01)00884838061637(21)B3CWC9, (01)00884838061637(21)F04F93, (01)00884838061637(21)F0HPXK, (01)00884838061637(21)F0JQKH, (01)00884838061637(21)F0JXDY, (01)00884838061637(21)B2VTD2, (01)00884838061637(21)B2XV7D, (01)00884838061637(21)B3607L, (01)00884838061637(21)F0BV1B, (01)00884838061637(21)F0C2Z4, (01)00884838061637(21)F0FCQ2, (01)00884838061637(21)F0H5F7, 010088483806163721F0G48N, (01)00884838061637(21)B3JRC9, (01)00884838061637(21)B1VWLQ, (01)00884838067561(21)B2G6HM, (01)00884838061637(21)B268WK, (01)00884838061637(21)B2NWWK, (01)00884838061637(21)B10QYZ, (01)00884838061637(21)B1220C, (01)00884838061637(21)B1NVB7, (01)00884838061637(21)B1TTWC, (01)00884838061637(21)B3MYLN, (01)00884838061637(21)B3QQ11, (01)00884838061637(21)F042V7, (01)00884838061637(21)F05D4P, (01)00884838061637(21)F05Y1W, (01)00884838061637(21)F093GW, (01)00884838061637(21)F0B4JJ, (01)00884838061637(21)F0CKCW, (01)00884838061637(21)F0D6HL, (01)00884838061637(21)F0FGXQ, (01)00884838067561(21)B2BK3M, (01)00884838061637(21)B3D87C, (01)00884838061637(21)F0431N, (01)00884838061637(21)B1Q60C, (01)00884838061637(21)B15CZK, (01)00884838061637(21)B22JYW, (01)00884838061637(21)B2BKK8, (01)00884838061637(21)F0GNF3, (01)00884838067561(21)B0R4NP, (01)00884838067561(21)B1CWF6, (01)00884838067561(21)B2NWMZ, (01)00884838061637(21)B1Q2KW, (01)00884838061637(21)B3J9LX, 010088483806163721F023MC, (01)00884838061637(21)B3VDB0, (01)00884838061637(21)B3JGYB, (01)00884838061637(21)F09VV8, (01)00884838061637(21)B389CH, (01)00884838061637(21)B1NRX3, (01)00884838067561(21)B10QQY, (01)00884838061637(21)F02KNK, (01)00884838061637(21)B25MNB, (01)00884838061637(21)B25MPG, (01)00884838067561(21)B3C6CL, (01)00884838061637(21)B1QW3N, (01)00884838061637(21)B22JF4, (01)00884838061637(21)F07PKX, (01)00884838061637(21)F0C2XJ, (01)00884838061637(21)F0C31L, (01)00884838067561(21)F0273Q, (01)00884838061637(21)F056W8, (01)00884838061637(21)F0GNR8, (01)00884838061637(21)B1TV05, (01)00884838061637(21)B1TV1B, (01)00884838061637(21)B3GLLB, 010088483806163721F0G6XC, (01)00884838061637(21)B2BK7C, (01)00884838061637(21)F0DH8K, (01)00884838061637(21)B3F6L0, (01)00884838061637(21)B3N1FB, (01)00884838061637(21)F0DDJB, (01)00884838061637(21)B286Y2, (01)00884838061637(21)F0L8T9, (01)00884838061637(21)F0GBTR, (01)00884838067561(21)B1TV4L, (01)00884838067561(21)B39DP0, (01)00884838061637(21)B1KD04, (01)00884838067561(21)B3CHPC, (01)00884838061637(21)F0C98N, (01)00884838061637(21)F0CB4L, (01)00884838061637(21)B20ZNG, (01)00884838067561(21)B2VRN3, (01)00884838067561(21)B39DMG, (01)00884838061637(21)F0CZP4, (01)00884838067561(21)B1LFPT, (01)00884838067561(21)B1TTRJ, (01)00884838067561(21)B20ZLQ, (01)00884838067561(21)B0R4Y9, (01)00884838061637(21)B2PH85, (01)00884838061637(21)B34J56, (01)00884838061637(21)B1GNFP, (01)00884838061637(21)F0L9FH, (01)00884838061637(21)B3VHXV, (01)00884838061637(21)F07QQJ, (01)00884838061637(21)B1VHQV, (01)00884838067561(21)B2NW51, (01)00884838061637(21)B2FN0W, (01)00884838061637(21)B2FN2F, (01)00884838061637(21)B2G6D9, (01)00884838061637(21)B2G6FH, (01)00884838061637(21)B2G6GD, (01)00884838061637(21)B2G6GM, (01)00884838061637(21)B2G6HK, (01)00884838061637(21)B2G6K0, (01)00884838061637(21)B3741R, (01)00884838061637(21)F015ZX, (01)00884838061637(21)F0FF4Y, (01)00884838061637(21)F0G5C0, (01)00884838061637(21)F0KDNN, (01)00884838067561(21)B09M1Y, (01)00884838067561(21)B20Z8K, (01)00884838061637(21)F0F537, (01)00884838061637(21)F0FML3, (01)00884838061637(21)B2LNRJ, (01)00884838061637(21)F04RGC, (01)00884838061637(21)F0CJ6Z, (01)00884838061637(21)F0D22P, (01)00884838067561(21)F08HRB, (01)00884838061637(21)B351H1, (01)00884838067561(21)B1L2P9, (01)00884838067561(21)B3VBQY, (01)00884838061637(21)B1Q61H, (01)00884838061637(21)B287HK, (01)00884838061637(21)B2WWXZ, (01)00884838061637(21)F08PY1, (01)00884838061637(21)B1YV15, (01)00884838061637(21)B31XCM, (01)00884838067561(21)B0KDL5, 010088483806163721F0FYZJ, (01)00884838061637(21)B2PH5G, (01)00884838067561(21)B0KD2H, (01)00884838061637(21)B2RM8G, (01)00884838061637(21)B25MTF, (01)00884838061637(21)F0CTKP, (01)00884838061637(21)F02KKG, (01)00884838061637(21)F02KP4, (01)00884838061637(21)F07F93, (01)00884838061637(21)B3VJ2J, (01)00884838061637(21)B3VJ7J, (01)00884838061637(21)B3VRXC, (01)00884838061637(21)B3JRDX, (01)00884838061637(21)B29GWQ, (01)00884838061637(21)B2LPFH, (01)00884838067561(21)... |
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.