Recall archive / FDA device enforcement
L12-5 50 Transducer Probe — FDA record Z-2376-2025
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
- L12-5 50 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-2376-2025
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. 989605418552, 989605408173, 989605438481, 989605420231, 989605412401, 989605408171, 989605362313, 989605396002, 989605387311, 989605412042, 989605418551, 989605409562, 989605412072, 989605409582, 989605440931, 989605361882, 989605440932; UDI: (01)00884838067851(21)B1N28J, (01)00884838067851(21)B1N2GB, (01)00884838067851(21)B20JW8, (01)00884838067851(21)B2TL6N, (01)00884838067851(21)B2TM54, (01)00884838067851(21)B2TNPZ, (01)00884838067851(21)B2TPD0, (01)00884838067851(21)B2ZJYP, (01)00884838067974(21)B24F91, (01)00884838067851(21)B2TMH2, 010088483806785121F0FNVH, 010088483806785121F0FQMW, 010088483806785121F0FQNJ, (01)00884838067851(21)B24NM7, (01)00884838067851(21)B2D9MB, (01)00884838067851(21)B2D9VH, (01)00884838067851(21)B2H8B5, (01)00884838067851(21)B2PL21, (01)00884838067851(21)B40HY0, (01)00884838067851(21)B40J43, (01)00884838067974(21)B1N1NV, (01)00884838067851(21)B3XX7R, (01)00884838067851(21)F088MN, (01)00884838067851(21)B0P7DV, (01)00884838067851(21)B2ZHQ3, (01)00884838067851(21)B40VT9, (01)00884838067851(21)F0589C, (01)00884838067851(21)F0CHBM, (01)00884838067851(21)F0FNT5, (01)00884838067851(21)F0JZNN, 010088483806785121F0FZWN, 010088483806785121F0FZXK, (01)00884838067851(21)B20QHY, (01)00884838067851(21)B20GD4, (01)00884838067851(21)F0JTMB, 010088483806785121B3XJNR, (01)00884838067851(21)B39N0H, (01)00884838067974(21)B0LMXB, (01)00884838067974(21)B2H5LC, (01)00884838067974(21)B2PR9K, (01)00884838067974(21)B2ZK20, (01)00884838067974(21)B2ZW1C, (01)00884838067851(21)B3VYGB, (01)00884838067974(21)B32MGJ, (01)00884838067851(21)B2ZHPT, (01)00884838067851(21)B1MZMY, (01)00884838067851(21)B1N1VC, (01)00884838067851(21)B1N1ZN, (01)00884838067851(21)B1N2BX, (01)00884838067851(21)B2H8KQ, (01)00884838067851(21)B2ZQ8Q, (01)00884838067974(21)B1RPHD, (01)00884838067851(21)B3YXXG, (01)00884838067974(21)B1WT04, (01)00884838067974(21)B0P7BK, (01)00884838067974(21)B2PQQC, (01)00884838067974(21)B2ZQJC, (01)00884838064560(21)B1NM4R, (01)00884838064560(21)B31LJP, (01)00884838064560(21)B2P464, (01)00884838067851(21)B27MCF, (01)00884838067974(21)B1RLL1, (01)00884838067974(21)B24M9M, (01)00884838067974(21)B2ZPG9, (01)00884838067974(21)B32LRR, (01)00884838067851(21)B20FY7, (01)00884838067851(21)B1N1B9, (01)00884838067851(21)B1N1WX, (01)00884838067851(21)B27GGJ, (01)00884838067851(21)B27GHL, (01)00884838067851(21)B24HLF, (01)00884838067851(21)B3HM8Q, (01)00884838067851(21)B3W635, (01)00884838067851(21)B3Y4PW, (01)00884838067851(21)F0B44R, (01)00884838067851(21)F0BDJ2, (01)00884838067851(21)F0FVDD, (01)00884838067851(21)B1X05M, (01)00884838067851(21)B2TP3F, (01)00884838067851(21)F08XWD, (01)00884838067851(21)B1N1PV, (01)00884838067851(21)B2PL1F, (01)00884838067851(21)B2ZV79, (01)00884838067851(21)B2ZW3W, (01)00884838067851(21)B3XFW9, (01)00884838067851(21)B40J0D, (01)00884838067851(21)F079WF, (01)00884838061569(21)F00W6R, (01)00884838061569(21)F08HWD, (01)00884838067851(21)B3VYJG, (01)00884838067851(21)F07Y02, (01)00884838067851(21)F07YKX, (01)00884838067851(21)F08BQB, (01)00884838067851(21)F09Z6G, (01)00884838067851(21)F0G5PX, (01)00884838067851(21)F0JWY3, (01)00884838067851(21)B20J0X, (01)00884838067974(21)B1RHQQ, (01)00884838067974(21)B1X005, (01)00884838061569(21)B2FXZ0, (01)00884838067974(21)B24F6H, (01)00884838067851(21)B20J1R, (01)00884838067851(21)B20J46, (01)00884838067851(21)B20JYP, (01)00884838067851(21)F0GFM1, (01)00884838067851(21)B20P5J, (01)00884838067851(21)B20PB9, (01)00884838067851(21)B20PLH, (01)00884838067851(21)B24F0M, (01)00884838067851(21)B20NTR, (01)00884838067851(21)B20Q0T, (01)00884838067974(21)B1RHMM, (01)00884838067851(21)B3LDRT, (01)00884838067851(21)B27MVF, (01)00884838067851(21)B27MWK, (01)00884838067851(21)B27N5V, (01)00884838067851(21)B35HW7, (01)00884838067851(21)B35PWY, (01)00884838067851(21)B3FHK0, (01)00884838067851(21)B3FHK1, (01)00884838067851(21)F0JWY6, (01)00884838067851(21)B24P9Z, (01)00884838067851(21)B24Q9N, (01)00884838067851(21)B24T11, (01)00884838067851(21)B2PRC0, (01)00884838067851(21)B1MZ44, (01)00884838067851(21)B3WNW6, (01)00884838067851(21)B3XYP8, (01)00884838067851(21)F0BDHK, (01)00884838067851(21)F0BGZ8, (01)00884838064560(21)B31XHQ, (01)00884838067851(21)B24F1F, (01)00884838067851(21)B3XWTX, (01)00884838067851(21)F0JPRM, (01)00884838067851(21)B27GQ1, (01)00884838067851(21)B2H4T1, (01)00884838067851(21)B3W3BR, (01)00884838067851(21)B1MYZX, (01)00884838067851(21)B1N2KL, (01)00884838067851(21)B1N2XP, (01)00884838067851(21)B39JRF, (01)00884838067851(21)B3Z06Q, (01)00884838067851(21)B3Z0WJ, (01)00884838067851(21)F0DQNX, (01)00884838067974(21)B1RL0Y, (01)00884838067974(21)B27N9P, (01)00884838067851(21)B3XFWX, (01)00884838067851(21)B27GMG, (01)00884838067851(21)B2TN48, (01)00884838067851(21)B3ZBH8, (01)00884838067851(21)B3ZPFY, (01)00884838067851(21)B3XXFF, (01)00884838067851(21)B3ZCYW, (01)00884838067851(21)B1N1JV, (01)00884838067851(21)B1WQQN, (01)00884838067851(21)B1WTL8, (01)00884838067851(21)B1WYMX, (01)00884838067851(21)B2TMHK, (01)00884838067851(21)B27H2Q, (01)00884838067851(21)B27MM9, (01)00884838067851(21)B27H5C, (01)00884838067851(21)B20GDT, (01)00884838067851(21)B24F9D, (01)00884838067974(21)B1RFLB, (01)00884838067974(21)B2GYTT, (01)00884838067851(21)F0K7RN, (01)00884838067851(21)B24FJ9, (01)00884838064560(21)B389CM, (01)00884838067974(21)B1WY6D, (01)00884838067851(21)B24NGT, (01)00884838067851(21)B3WQ1Q, (01)00884838067851(21)B1WTCG, (01)00884838067851(21)B3FGPH, (01)00884838067974(21)B2PNGG, (01)00884838064560(21)B3604H, (01)00884838067851(21)B20PDL, (01)00884838067851(21)B2PRBQ, (01)00884838067974(21)B32LRW, (01)00884838067974(21)B35JR0, (01)00884838067974(21)B3XJFZ, (01)00884838067851(21)B27NGP, (01)00884838067974(21)B24PZK, (01)00884838067851(21)F04MVJ, (01)00884838067851(21)B2ZHMG, (01)00884838067851(21)B1N2HX, (01)00884838067851(21)B3HLMQ, (01)00884838061569(21)B29XPW, (01)00884838061569(21)B3R4KF, (01)00884838067851(21)B1RG0P, (01)00884838067851(21)B1WRVL, (01)00884838067851(21)B1WXRK, (01)00884838067851(21)F06H57, (01)00884838067851(21)F07TRP, (01)00884838067851(21)F08HHZ, (01)00884838067851(21)B24PQW, (01)00884838067851(21)B24T0D, (01)00884838067851(21)F0CRQ1, (01)00884838067974(21)B1X001, (01)00884838067851(21)B40H88, (01)00884838067851(21)B24PY0, (01)00884838067851(21)B3XR9W, (01)00884838067851(21)B3X104, (01)00884838067851(21)B1RLDW, (01)00884838067851(21)B1RM37, (01)00884838067851(21)B24T12, (01)00884838067974(21)B1WY43, (01)00884838067974(21)B2H7ZC, (01)00884838067851(21)B20Q0V, (01)00884838067851(21)B20QG5, (01)00884838067851(21)B2TNWW, (01)00884838067851(21)B2ZV5T, (01)00884838067974(21)B3Y2T7, (01)00884838067851(21)B3YT42, (01)00884838067851(21)F06PL0, (01)00884838067851(21)F06PL6, (01)00884838067851(21)B1X372, (01)00884838067851(21)B27NBZ, (01)00884838067974(21)B1MZWN, (01)00884838067974(21)B2ZHYX, (01)00884838067974(21)B35H6Y, (01)00884838067851(21)B1N1XF, (01)00884838067851(21)B27T2J, (01)00884838067851(21)B2TNWQ, (01)00884838067851(21)F0778N, (01)00884838067851(21)F0BDH2, (01)00884838067851(21)B1WRXD, (01)00884838067851(21)B2TP7L, (01)00884838067851(21)B1WTF8, (01)00884838067851(21)B1X0K2, (01)00884838067851(21)B2TM23, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B1MX3F, (01)00884838067974(21)B1RHKB, (01)00884838067974(21)B20K2G, (01)00884838067974(21)B27NT7, (01)00884838067974(21)B35D65, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1RFQM, (01)00884838067851(21)B1RG2N, (01)00884838067851(21)B24FPF, (01)00884838067851(21)B24PXP, (01)00884838064560(21)B29XL5, (01)00884838067974(21)B2H3C2, (01)00884838067974(21)B2ZVFW, (01)00884838067974(21)B32MJ7, (01)00884838067974(21)B20KC0, (01)00884838067851(21)B3YR5N, (01)00884838067851(21)B3YRQH, (01)00884838067974(21)B1X0RP, (01)00884838067851(21)B1RLQ9, (01)00884838067974(21)B32MK8, (01)00884838067974(21)B1RG7W, (01)00884838067851(21)B1RHVM, (01)00884838067851(21)B20HHD, (01)00884838067851(21)B1N1NN, (01)00884838067851(21)B1RKR1, (01)00884838067851(21)B1RPMT, (01)00884838067851(21)B1WXVX, (01)00884838067851(21)B3WWQK, (01)00884838067851(21)B3WXD1, (01)00884838067851(21)B24P4N, (01)00884838067851(21)B1RFTT, (01)00884838067851(21)B20JP4, (01)00884838067851(21)B3XR4M, (01)00884838067974(21)B1MZMB, (01)00884838067851(21)B1RHGN, (01)00884838067851(21)B3FHBF, (01)00884838067851(21)B3L4XZ, (01)00884838067851(21)B3X58X, (01)00884838067851(21)B3XDM3, (01)00884838067851(21)B3XFCK, (01)00884838067851(21)B3XG5Y, (01)00884838067851(21)B27FDD, (01)00884838067851(21)B1WT47, (01)00884838067851(21)B1N2ZN, (01)00884838067974(21)B1RLQ3, (01)00884838067851(21)F0GHWD, (01)00884838067851(21)B24HLB, (01)00884838067851(21)B2D985, (01)00884838067851(21)F09693, 010088483806785121B3XJ73, 010088483806785121B3XJNY, (01)00884838067974(21)B27FV1, (01)00884838064560(21)B1YT3V, (01)00884838067851(21)B39JP6, (01)00884838067851(21)B24PR5, (01)00884838067851(21)B27GP4, (01)00884838067851(21)F0DP0R, (01)00884838067974(21)B1MRB7, (01)00884838067974(21)B39HG4, (01)00884838067851(21)B20JL9, (01)00884838067851(21)B20JQ2, (01)00884838067851(21)B2DGMQ, (01)00884838067974(21)B1N1QG, (01)00884838067974(21)B1WZTM, (01)00884838067851(21)B3X5X7, (01)00884838067851(21)B1N2Z0, (01)00884838067851(21)B2DD06, (01)00884838067974(21)B20HL6, (01)00884838067851(21)B24P9W, (01)00884838067974(21)B35H43, (01)00884838067974(21)B35D64, (01)00884838067851(21)B2H8H2, (01)00884838061569(21)F099J1, (01)00884838064560(21)B1F3MZ, (01)00884838067851(21)B20HW0, (01)00884838067851(21)B2GYZW, (01)00884838067851(21)B2H4YJ, (01)00884838067851(21)B2ZQ7G, (01)00884838067851(21)B3LDNV, (01)00884838067851(21)B1RKW5, (01)00884838067974(21)B35JRD, (01)00884838067851(21)B20K05, (01)00884838067851(21)B20K6F, (01)00884838067851(21)B20NJ7, (01)00884838067851(21)B27PKZ, (01)00884838067851(21)B2DCYD, (01)00884838067851(21)B2DCYG, (01)00884838067851(21)B2DD4X, (01)00884838067851(21)B2DDB2, (01)00884838067851(21)F07ZRC, (01)00884838067851(21)F098CH, (01)00884838067851(21)F0FNRK, (01)00884838067974(21)F092Y4, (01)00884838067851(21)B1RLKN, (01)00884838067851(21)B20JNB, (01)00884838067851(21)B20JWL, (01)00884838067851(21)B24NRK, (01)00884838067851(21)F0CPXP, (01)00884838067851(21)F0GCZL, (01)00884838067851(21)B3FRZQ, (01)00884838067851(21)B3W4NX, (01)00884838067851(21)B2DD2Q, (01)00884838067851(21)B2DD0P, 010088483806785121F0GHTD, (01)00884838067974(21)B2ZPTX, (01)00884838067851(21)B24PXZ, (01)00884838067851(21)B3ZHJZ, (01)00884838067851(21)B3ZJZZ, (01)00884838067851(21)F0BBWH, (01)00884838067851(21)B3VXXQ, (01)00884838067851(21)B27NHX, (01)00884838067851(21)B1MZ0G, (01)00884838067851(21)B1MZB1, (01)00884838067851(21)F09P8K, (01)00884838067851(21)F0B35Z, (01)00884838067851(21)B20JCP, (01)00884838067851(21)B20JWP, 010088483806785121B3XJTL, 010088483806785121B3XQPL, (01)00884838067851(21)B1RPLH, (01)00884838064560(21)B34LNH, (01)00884838067974(21)B20PR1, (01)00884838067851(21)B20P2F, (01)00884838067974(21)B20NP6, (01)00884838067851(21)B2ZK2Q, (01)00884838067851(21)B39ND2, (01)00884838067851(21)B3FH2Q, (01)00884838067851(21)B3TC8Y, (01)00884838067974(21)B20K1M, (01)00884838067851(21)B1WYPB, (01)00884838067851(21)B1X03V, (01)00884838067851(21)B20JZ8, (01)00884838067851(21)B3LF9D, (01)00884838067851(21)B3ZHY3, (01)00884838064560(21)B2C47J, (01)00884838067851(21)B24P14, (01)00884838067974(21)B2DDTM, (01)00884838064560(21)B3RQXD, (01)00884838067851(21)B40HH0, (01)00884838067974(21)B2GYRQ, (01)00884838067851(21)B2ZK08, (01)00884838067851(21)B3FGRF, (01)00884838064560(21)B288N3, (01)00884838067974(21)B0PBJH, (01)00884838061569(21)F05D96, (01)00884838067851(21)F0B3Z0, (01)00884838064560(21)B29XL1, (01)00884838067851(21)F0JWWQ, (01)00884838067851(21)F08HH6, (01)00884838067974(21)B27G09, (01)00884838067974(21)B2DCZ8, (01)00884838067974(21)B35DL8, (01)00884838067851(21)B27GD8, (01)00884838067851(21)B27GNR, (01)00884838067851(21)B40GH7, (01)00884838067851(21)F0J1M6, (01)00884838061569(21)F099J2, (01)00884838067851(21)F08TY3, (01)00884838067851(21)B20NQL, (01)00884838067851(21)B2PR50, (01)00884838067851(21)F0B442, (01)00884838067974(21)B1RFT5... |
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.