Recall archive / FDA device enforcement
C8-5 Transducer Probe — FDA record Z-2359-2025
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
- C8-5 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-2359-2025
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. 989605391922, 989605438441, 989605440822, 989605387852, 989605387281, 989605391092, 8500-1664-01, 989605352343, 989605352342; UDI: (01)00884838061514(21)B1Q41K, (01)00884838061514(21)B1QB9Z, (01)00884838061514(21)B2859G, (01)00884838061514(21)B2YTR3, (01)00884838061514(21)B2YTTV, (01)00884838061514(21)B3F4JN, (01)00884838061514(21)F08DZC, 010088483806151421F01W6L, (01)00884838061514(21)F04XX6, (01)00884838061514(21)F0FCL7, (01)00884838061514(21)B3B4RD, (01)00884838061514(21)B288HM, (01)00884838061514(21)B2FXYD, (01)00884838061514(21)B2FXZB, (01)00884838061514(21)B1P4JM, (01)00884838061514(21)B1P9ZG, (01)00884838061514(21)B338L3, (01)00884838061514(21)F0C7VZ, (01)00884838061514(21)F0FHNV, (01)00884838061514(21)F0KM0Y, (01)00884838061514(21)B22GYC, (01)00884838061514(21)B21T06, (01)00884838067691(21)B26NBY, (01)00884838061514(21)B34J00, (01)00884838061514(21)B2FXJK, (01)00884838067691(21)B2882D, (01)00884838067691(21)B288VM, (01)00884838067691(21)B2FY2G, (01)00884838061514(21)B2YH6Z, (01)00884838061514(21)B30Q8X, 010088483806151421F0G4ZF, (01)00884838061514(21)F011BM, (01)00884838061514(21)B1QBW2, (01)00884838061514(21)B1QTN7, (01)00884838061514(21)B1QTVX, (01)00884838061514(21)B2YGHZ, (01)00884838061514(21)F018FW, (01)00884838061514(21)B37W7W, (01)00884838061514(21)B22NLJ, (01)00884838067691(21)B338F0, (01)00884838061514(21)B216LD, (01)00884838061514(21)F0B6W5, (01)00884838061514(21)B287ZV, (01)00884838061514(21)B288BD, (01)00884838061514(21)B29XXK, (01)00884838061514(21)B2FXQB, (01)00884838061514(21)B2FXV3, (01)00884838061514(21)B3CW78, (01)00884838061514(21)F08CCW, (01)00884838061514(21)F0FMW0, (01)00884838061514(21)F0L128, (01)00884838061514(21)B1P76L, (01)00884838061514(21)B1NYWZ, (01)00884838061514(21)B1Q340, (01)00884838061514(21)B1Q3CC, (01)00884838061514(21)B338NR, (01)00884838061514(21)B338RN, (01)00884838061514(21)B3J3FV, (01)00884838061514(21)B3J3G8, (01)00884838061514(21)B3M1RQ, (01)00884838061514(21)B3M1RR, (01)00884838061514(21)B3MPP0, (01)00884838061514(21)B3MZLX, (01)00884838061514(21)F089LG, (01)00884838061514(21)B351HN, (01)00884838061514(21)B351XC, (01)00884838061514(21)F09Z11, (01)00884838061514(21)B22GD9, (01)00884838061514(21)B26N7F, (01)00884838061491(21)B2JTQ2, (01)00884838061514(21)B1VKMR, (01)00884838061514(21)B2888T, (01)00884838061514(21)B1P9PT, (01)00884838061514(21)B1Q42P, (01)00884838061514(21)B28BRF, (01)00884838061514(21)B2W90F, (01)00884838067691(21)B2T82Z, (01)00884838061514(21)B1ZQHL, (01)00884838061514(21)B28549, (01)00884838061514(21)B285PT, (01)00884838067691(21)F090YB, (01)00884838067691(21)B2WXYT, (01)00884838061514(21)B28515, (01)00884838061514(21)F014Q9, (01)00884838061514(21)B28N4F, (01)00884838061514(21)F0FXK7, (01)00884838061514(21)B2X93W, (01)00884838061514(21)B1W3RV, (01)00884838061514(21)B3CW8Y, (01)00884838061514(21)B3DGJZ, (01)00884838061514(21)B22GNP, (01)00884838061514(21)B22H1D, (01)00884838061514(21)B1PJ5F, (01)00884838061514(21)B3G4B9, (01)00884838061514(21)B1YCVY, (01)00884838061514(21)F011BR, (01)00884838061514(21)B2P49P, (01)00884838061514(21)B2692H, (01)00884838067691(21)B1ZRKQ, (01)00884838067691(21)B288TC, (01)00884838061514(21)B268YQ, (01)00884838061514(21)B28ZHL, (01)00884838061514(21)B1Q5L1, (01)00884838061514(21)B1Q39L, (01)00884838061514(21)B2P47R, (01)00884838061514(21)B25GQ3, (01)00884838061514(21)F03W7G, (01)00884838061514(21)B1TJK3, (01)00884838061514(21)F09XT2, (01)00884838061514(21)F0GH4Y, (01)00884838061514(21)F091C0, (01)00884838067691(21)B26PDD, (01)00884838067691(21)B1P76K, (01)00884838067691(21)B1ZR2J, (01)00884838067691(21)B2FY19, (01)00884838067691(21)B338JZ, (01)00884838061514(21)B2FXXT, (01)00884838061514(21)B1P4DY, (01)00884838061514(21)B2274H, (01)00884838061514(21)B2274K, (01)00884838061514(21)B28606, (01)00884838061514(21)F032DL, (01)00884838061514(21)B3F6BW, (01)00884838061514(21)B34MNN, (01)00884838061514(21)B22LRZ, (01)00884838061514(21)B29XV9, (01)00884838061514(21)B29XVD, (01)00884838061514(21)B3H14J, (01)00884838061514(21)F02M3R, (01)00884838061514(21)F03W7D, (01)00884838061514(21)F07LXR, (01)00884838061514(21)F0GFF7, (01)00884838067691(21)B1QBPX, (01)00884838061514(21)B25226, (01)00884838061514(21)B288LW, (01)00884838061514(21)B22GG1, (01)00884838061514(21)B3VDGB, (01)00884838061514(21)B269GQ, (01)00884838061514(21)B1PL08, (01)00884838061514(21)F036NG, (01)00884838061514(21)F02CV3, (01)00884838061514(21)F03ZGJ, (01)00884838061514(21)F03ZGL, (01)00884838061514(21)B26Q62, (01)00884838061514(21)B34LN8, (01)00884838061514(21)F01ZTQ, (01)00884838061514(21)B2BGFB, (01)00884838061514(21)B2DVVQ, (01)00884838061514(21)B351DF, (01)00884838061514(21)B35ZV4, (01)00884838061514(21)B2P44Q, (01)00884838061514(21)B38D9V, (01)00884838061514(21)B3JGVY, (01)00884838067691(21)B1PL03, (01)00884838061514(21)B1VJVY, (01)00884838061514(21)B1XP0J, (01)00884838061514(21)B288LT, (01)00884838061514(21)B288LY, (01)00884838067691(21)F003HC, (01)00884838061514(21)B1YCFV, (01)00884838061514(21)B1ZR38, (01)00884838061514(21)B38X0B, (01)00884838061514(21)B28M7W, (01)00884838061514(21)B284Z1, (01)00884838061514(21)B1PJZM, (01)00884838061514(21)B28547, (01)00884838061514(21)B28N99, (01)00884838061514(21)B1VPC9, 010088483806151421F0252G, (01)00884838061514(21)B22GG3, (01)00884838061514(21)B25FHY, (01)00884838061514(21)B26N6L, (01)00884838061514(21)B26N6M, (01)00884838061514(21)B39DGQ, (01)00884838061514(21)B1VKXR, (01)00884838067691(21)B2WXZQ, (01)00884838067691(21)B22M7N, (01)00884838061514(21)B1QT10, (01)00884838061514(21)B2FXND, (01)00884838061514(21)F0BZJQ, (01)00884838061514(21)B22G2X, (01)00884838061514(21)B2C47H, (01)00884838067691(21)B2YGQW, (01)00884838067691(21)B31XC3, (01)00884838061514(21)B1YD1Y, (01)00884838061514(21)B288KC, (01)00884838061514(21)B2YGRP, (01)00884838061514(21)B37W7Y, (01)00884838061514(21)B3GLJ7, (01)00884838061514(21)B3KQX6, (01)00884838061514(21)F003L4, (01)00884838061514(21)F04359, (01)00884838061514(21)B1ZR39, (01)00884838061514(21)B23MG9, (01)00884838061514(21)B3J3FM, (01)00884838061514(21)F04T7X, (01)00884838067691(21)B1ZT5M, (01)00884838067691(21)B31XBB, (01)00884838067691(21)F086DH, (01)00884838061514(21)B31XFD, (01)00884838061514(21)B38D6K, (01)00884838061514(21)B3H11L, (01)00884838061514(21)B3H154, (01)00884838061514(21)B3H17W, (01)00884838061514(21)B1P9TL, (01)00884838061514(21)B269LY, (01)00884838061514(21)B29XG3, (01)00884838061514(21)B1VPC8, (01)00884838061514(21)B2YGJB, (01)00884838061514(21)F0B1XY, (01)00884838067691(21)B338FM, (01)00884838061514(21)B1VJY2, (01)00884838061514(21)B34MJR, (01)00884838061514(21)B34MPM, (01)00884838067691(21)B289L0, (01)00884838061514(21)B22LQB, (01)00884838067691(21)B26Q76, (01)00884838067691(21)B2Y0VM, (01)00884838067691(21)B3RQFB, (01)00884838061514(21)B2P4QR, (01)00884838061514(21)B1NZ1J, (01)00884838061514(21)B29KBH, (01)00884838067691(21)B1WH3H, (01)00884838067691(21)B288NY, (01)00884838067691(21)B288P1, (01)00884838061514(21)B284TH, (01)00884838061514(21)B31L86, (01)00884838061514(21)F02W8N, (01)00884838061514(21)F02WYN, (01)00884838061514(21)B3JGXH, (01)00884838061514(21)B1XD4N, (01)00884838061514(21)B2YHFV, (01)00884838067691(21)B2WXQK, (01)00884838067691(21)B3NBLV, (01)00884838061514(21)B28MBB, (01)00884838061514(21)B29JNC, (01)00884838061514(21)B29D7R, (01)00884838061514(21)B285WY, (01)00884838061514(21)B28N69, (01)00884838061514(21)F040Z3, (01)00884838061514(21)B22G2Y, (01)00884838061514(21)B29DGR, (01)00884838061514(21)B2FY3N, (01)00884838061514(21)B2P4C2, (01)00884838061514(21)B2P4CP, (01)00884838061514(21)B2P4CX, (01)00884838061514(21)B2P4CZ, (01)00884838061514(21)B2P4F2, (01)00884838061514(21)B2P4F6, (01)00884838061514(21)B2P4FL, (01)00884838061514(21)B3G477, (01)00884838067691(21)B289KT, (01)00884838067691(21)B227NR, (01)00884838061514(21)B25G9Z, (01)00884838061514(21)F044ZC, (01)00884838067691(21)B26PJ9, (01)00884838061514(21)B3J3G7, (01)00884838067691(21)B288GZ, (01)00884838061514(21)B22H8Z, (01)00884838061514(21)B2Y0VT, (01)00884838061514(21)B2YGHV, (01)00884838061514(21)F02PZC, (01)00884838061514(21)B1W3XN, (01)00884838061514(21)B22H7H, (01)00884838067691(21)B25FXP, (01)00884838061514(21)B34JK0, (01)00884838061514(21)B1XDH3, (01)00884838061514(21)B2WXRJ, (01)00884838061514(21)B1RTC0, (01)00884838061514(21)B3RBBN, (01)00884838061514(21)B3H17X, (01)00884838067691(21)B3MH53, (01)00884838061514(21)B2FXR0, (01)00884838061514(21)B25H3Q, (01)00884838067691(21)B1VK37, (01)00884838061514(21)B2FXMF, (01)00884838061514(21)B25GTZ, (01)00884838061514(21)B25H9C, (01)00884838061514(21)B26N3D, (01)00884838067691(21)B2FY1M, (01)00884838061514(21)B3JH03, (01)00884838061514(21)B22GYF, (01)00884838061514(21)B269PG, (01)00884838061514(21)B26NQP, (01)00884838067691(21)B1YD1W, (01)00884838061514(21)B211WN, (01)00884838061514(21)B2YTQ0, (01)00884838061514(21)B1PK82, (01)00884838061514(21)B2FXNW, (01)00884838061514(21)B2FXXP, (01)00884838061514(21)B268YW, (01)00884838067691(21)B1PJTF, (01)00884838061514(21)B251P5, (01)00884838061514(21)B3606Z, (01)00884838061514(21)B22N84, (01)00884838061514(21)B1VKZ0, (01)00884838061514(21)B1VPQ7, (01)00884838061514(21)B3GLVJ, (01)00884838061514(21)B3NT58, (01)00884838061514(21)F00Y9W, (01)00884838061514(21)F06HWZ, 010088483806151421F027PG, (01)00884838061514(21)B2277X, (01)00884838061514(21)B2P499, (01)00884838061514(21)F0BZJC, (01)00884838061514(21)B3KM20, (01)00884838067691(21)B1VKDD, (01)00884838067691(21)B2883K, (01)00884838061514(21)B284YZ, (01)00884838061514(21)B28N64, (01)00884838061514(21)B28517, (01)00884838067691(21)B29K8Z, (01)00884838067691(21)B2P458, (01)00884838067691(21)B31L61, (01)00884838061514(21)B34MW3, (01)00884838061514(21)B3J3F4, (01)00884838061514(21)B26PL0, (01)00884838061514(21)B3HDPZ, (01)00884838061514(21)F08DZB, (01)00884838067691(21)F062B5, (01)00884838067691(21)F086DG, (01)00884838061514(21)B26NDP, (01)00884838061514(21)B2P44T, (01)00884838061514(21)B1XNCK, (01)00884838061514(21)F078BG, (01)00884838061514(21)B38X0D, (01)00884838061514(21)B1PK6L, (01)00884838061514(21)B25H66, (01)00884838061514(21)B39DKZ, (01)00884838061514(21)F04PYB, (01)00884838061514(21)B2FXK0, (01)00884838061514(21)B1XDVD, (01)00884838061514(21)B2FY0J, (01)00884838061514(21)B2WXN5, (01)00884838061514(21)B1X975, (01)00884838061514(21)B2YH5N, (01)00884838061514(21)B30Q8B, (01)00884838061514(21)B3C6CX, (01)00884838061514(21)B3C6D4, (01)00884838061514(21)F05XDJ, (01)00884838061514(21)B28896, (01)00884838061514(21)B288BC, (01)00884838061514(21)B2Y0VZ, (01)00884838061514(21)B20Y2M, (01)00884838061514(21)B3606B, (01)00884838061514(21)B2FXRY, (01)00884838061514(21)B34LG1, (01)00884838061514(21)B3CWCV, (01)00884838061514(21)F0651H, (01)00884838061514(21)B2698W, (01)00884838061514(21)B1VJM6, (01)00884838061514(21)B3J3GV, (01)00884838061514(21)B3JGZW, (01)00884838061514(21)B3JGY3, (01)00884838061514(21)B3H16M, (01)00884838067691(21)B1ZRX1, (01)00884838061514(21)B1VKNP, (01)00884838061514(21)B288P6, (01)00884838061514(21)F05JHH, (01)00884838067691(21)B22P8K, (01)00884838061514(21)B31LJ9, (01)00884838061514(21)B31X46, (01)00884838061514(21)B31X6V, (01)00884838061514(21)B34MXC, (01)00884838061514(21)B3KM4P, (01)00884838061514(21)B1RY9F, (01)00884838061514(21)B1VKX7, (01)00884838061514(21)B22G83, (01)00884838061514(21)B39DNL, (01)00884838061514(21)B2YV6X, (01)00884838061514(21)B26B6T, (01)00884838061514(21)F0GF2W, (01)00884838061514(21)B2P4J9, (01)00884838067691(21)F04429, (01)00884838061514(21)B1TVMZ, (01)00884838061514(21)B34MQ1, (01)00884838061514(21)B288DL, (01)00884838061514(21)B288NP, (01)00884838061514(21)B29KB3, (01)00884838061514(21)B2FXZC, (01)00884838061514(21)B2FY04, (01)00884838061514(21)B2FY0H, (01)00884838061514(21)B2FY15, (01)00884838061514(21)B1PL00, (01)00884838061514(21)B1QBPW, (01)00884838067691(21)F08J79, (01)00884838061514(21)B20Y2N, (01)00884838061514(21)F004L1, (01)00884838061514(21)B2WXPT, (01)00884838061514(21)B2Y0TD, (01)00884838061514(21)B1XDQ9, (01)00884838061514(21)B22N0Q, (01)00884838061514(21)B288BH, (01)00884838061514(21)B39DMJ, (01)00884838061514(21)B1VQBL, (01)00884838061514(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.