Recall archive / FDA device enforcement

OEC 3D — FDA record Z-1820-2025

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 Mar 21, 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: OEC 3D
Reason: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Classification: Class II
Recalling firm: GE Medical Systems, LLC
Quantity: Total for both products: 3472 (2,919 US; 553 OUS)
Agency-reported status: Ongoing
Source record identifier: Z-1820-2025

Open the official record

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	Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097 FAHXTX00110 FAHXTX00111 FAHXTX00112 FAHXTX00114 FAHXTX00115 FAHXTX00116 FAHXTX00117 FAHXTX00118 FAHXTX00119 FAHXTX00120 FAHXTX00121 FAHXTX00122 FAHXTX00124 FAHXTX00125 FAHXTX00135 FAHXTX00137 FAHXTX00138 FAHXTX00151 FAHXTX00152 FAHXTX00155 FAHXTX00156 FAHXTX00162 FAHXTX00163 FAHXTX00166 FAHXTX00170 FAHXTX00171 FAHXTX00177 FAHXTX00178 FAHXTX00188 FAHXTX00192 FAHXTX00193 FAHXTX00202 FAHXTX00204 FAHXTX00211 FAHXTX00212 FAHXTX00217 FAHXTX00219 FAHXTX00220 FAHXTX00221 FAHXTX00222 FAHXTX00223 FAHXTX00224 FAHXTX00226 FAHXTX00227 FAHXTX00229 FAHXTX00230 FAHXTX00236 FAHXTX00240 FAHXTX00244 FAHXTX00261 FAHXTX00265 FAHXTX00266 FAHXTX00269 FAHXTX00271 FAHXTX00272 FAHXTX00273 FAHXTX00274 FAHXTX00280 FAHXTX00283 FAHXTX00284 FAHXTX00296 FAHXTX00299 FAHXTX00300 FAHXTX00304 FAHXTX00305 FAHXTX00308 FAHXTX00312 FAHXTX00313 FAHXTX00320 FAHXTX00323 FAHXTX00325 FAHXTX00332 FAHXTX00340 FAHXTX00342 FAHXTX00343 FAHXTX00352 FAHXTX00353 FAHXTX00354 FAHXTX00357 FAHXTX00358 FAHXTX00359 FAHXTX00360 FAHXTX00363 FAHXTX00376 FAHXTX00379 FAHXTX00381 FAHXTX00382 FAHXTX00390 FAHXTX00392 FAHXTX00399 FAHXTX00400 FAHXTX00410 FAHXTX00413 FAHXTX00414 FAHXTX00415 FAHXTX00420 FAHXTX00421 FAHXTX00429 FAHXTX00439 FAHXTX00453 FAHXTX00455 FAHXTX00456 FAHXTX00463 FAHXTX00465 FAHXTX00466 FAHXTX00479 FAHXTX00481 FAHXTX00483 FAHXTX00484 FAHXTX00486 FAHXTX00488 FAHXTX00495 FAHXTX00497 FAHXTX00498 FAHXTX00507 FAHXTX00509 FAHXTX00513 FAHXTX00523 FAHXTX00530 FAHXTX00534 FAHXTX00538 FAHXTX00539 FAHXTX00540 FAHXTX00547 FAHXTX00549 FAHXTX00555 FAHXTX00557 FAHXTX00560 FAHXTX00565 FAHXTX00569 FAHXTX00570 FAHXTX00571 FAHXTX00572 FAHXTX00575 FAHXTX00576 FAHXTX00579 FAHXTX00592 FAHXTX00595 FAHXTX00610 FAHXTX00611 FAHXXX00029 FAHXXX00030 FAHXXX00038 FAHXXX00040 FAHXXX00056 FAHXXX00057 FAHXXX00059 FAHXXX00060 FAHXXX00061 FAHXXX00069 FAHXXX00082 FAHXXX00085 FAHXXX00086 FAHXXX00089 FAHXXX00091 FAHXXX00093 FAHXXX00097 FAHXXX00098 FAHXXX00099 FAHXXX00105 FAHXXX00106 FAHXXX00112 FAHXXX00113 FAHXXX00114 FAHXXX00116 FAHXXX00117 FAHXXX00119 FAHXXX00123 FAHXXX00142 FAHXXX00144 FAHXXX00145 FAHXXX00147 FAHXXX00150 FAHXXX00151 FAHXXX00153 FAHXXX00155 FAHXXX00164 FAHXXX00173 FAHXXX00176 FAHXXX00178 FAHXXX00179 FAHXXX00188 FAHXXX00190 FAHXXX00193 FAHXXX00196 FAHXXX00199 FAHXXX00200 FAHXXX00207 FAHXXX00208 FAHXXX00209 FAMHTX00001 FAMHTX00005 FAMHTX00007 FAMHTX00012 FAMHTX00014 FAMHTX00041 FAMHTX00051 FAMHTX00055 FAMHTX00064 FAMHTX00069 FAMHTX00081 FAMHTX00085 FAMHXX00003 FAMHXX00011 FAMHXX00019 FAMHXX00023 FAXXTE00003 FAXXTE00006 FAXXTE00009 FAXXTE00011 FAXXTE00013 FAXXTE00014 FAXXTE00015 FAXXTE00017 FAXXTE00021 FAXXTE00022 FAXXTE00024 FAXXTE00025 FAXXTE00028 FAXXTE00031 FAXXTE00032 FAXXTE00033 FAXXTE00034 FAXXTE00035 FAXXTE00037 FAXXTE00038 FAXXTE00039 FAXXTE00040 FAXXTE00044 FAXXTE00046 FAXXTE00047 FAXXTE00049 FAXXTE00050 FAXXTE00051 FAXXTE00052 FAXXTE00056 FAXXTE00062 FAXXTE00063 FAXXTE00064 FAXXTE00067 FAXXTE00071 FAXXTE00072 FAXXTE00073 FAXXTE00076 FAXXTE00084 FAXXTE00085 FAXXTE00091 FAXXTE00092 FAXXTE00094 FAXXTE00095 FAXXTE00099 FAXXTE00100 FAXXTE00101 FAXXTE00104 FAXXTE00105 FAXXTE00106 FAXXTE00107 FAXXTE00109 FAXXTE00110 FAXXTE00114 FAXXTE00116 FAXXTE00117 FAXXTE00120 FAXXTE00121 FAXXTE00128 FAXXTE00129 FAXXTE00134 FAXXTE00136 FAXXTE00137 FAXXTE00141 FAXXTE00144 FAXXTE00145 FAXXTE00147 FAXXTE00149 FAXXTE00163 FAXXTE00164 FAXXTE00170 FAXXTE00173 FAXXTE00175 FAXXTE00179 FAXXTE00180 FAXXTE00182 FAXXTE00184 FAXXTE00185 FAXXTE00195 FAXXTE00197 FAXXTE00205 FAXXTE00212 FAXXTE00220 FAXXTE00224 FAXXTE00225 FAXXTE00227 FAXXTE00228 FAXXTE00229 FAXXTE00230 FAXXTE00231 FAXXTE00234 FAXXTE00236 FAXXTE00237 FAXXTE00238 FAXXTE00240 FAXXTE00241 FAXXTE00243 FAXXTE00246 FAXXTE00248 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FAXXTE00487 FAXXTE00489 FAXXTE00490 FAXXTE00491 FAXXTE00492 FAXXTE00495 FAXXTE00499 FAXXTE00506 FAXXTE00508 FAXXTE00511 FAXXTE00515 FAXXTE00516 FAXXTE00517 FAXXTE00518 FAXXTE00519 FAXXTE00522 FAXXTE00523 FAXXTE00525 FAXXTE00526 FAXXTE00527 FAXXTE00532 FAXXTE00533 FAXXTE00536 FAXXTE00539 FAXXTE00540 FAXXTE00543 FAXXTE00544 FAXXTE00545 FAXXTE00546 FAXXTE00547 FAXXTE00549 FAXXTE00550 FAXXTE00551 FAXXTE00553 FAXXTE00555 FAXXTE00560 FAXXTE00561 FAXXTE00562 FAXXTE00566 FAXXTE00570 FAXXTE00571 FAXXTE00572 FAXXTE00573 FAXXTE00582 FAXXTE00591 FAXXTE00593 FAXXTE00594 FAXXTE00596 FAXXTE00604 FAXXTE00607 FAXXTE00608 FAXXTE00611 FAXXTE00615 FAXXTE00616 FAXXTE00617 FAXXTE00618 FAXXTE00624 FAXXTE00631 FAXXTE00638 FAXXTE00639 FAXXTE00643 FAXXTE00646 FAXXTE00650 FAXXTE00651 FAXXTE00652 FAXXTE00653 FAXXTE00657 FAXXTE00661 FAXXTE00664 FAXXTE00667 FAXXTE00669 FAXXTE00672 FAXXTE00680 FAXXTE00681 FAXXTE00684 FAXXTE00685 FAXXTE00687 FAXXTE00688 FAXXTE00701 FAXXTE00706 FAXXTE00707 FAXXTE00710 FAXXTE00712 FAXXTE00713 FAXXTE00716 FAXXTE00718 FAXXTE00720 FAXXTE00724 FAXXTE00725 FAXXTE00728 FAXXTE00731 FAXXTE00734 FAXXTE00735 FAXXTE00737 FAXXTE00738 FAXXTE00747 FAXXTE00748 FAXXTE00749 FAXXTE00752 FAXXTE00753 FAXXTE00762 FAXXTE00766 FAXXTE00772 FAXXTE00789 FAXXTE00794 FAXXTE00799 FAXXTE00801 FAXXTE00805 FAXXTE00809 FAXXTE00810 FAXXTE00811 FAXXTE00814 FAXXTE00819 FAXXTE00820 FAXXTE00829 FAXXTE00831 FAXXTE00843 FAXXTE00853 FAXXTE00854 FAXXTE00874 FAXXTE00881 FAXXTE00893 FAXXTE00894 FAXXTE00896 FAXXTE00897 FAXXTE00899 FAXXTE00902 FAXXTE00903 FAXXTE00906 FAXXTE00909 FAXXTE00914 FAXXTE00915 FAXXTE00916 FAXXTE00917 FAXXTE00918 FAXXTE00919 FAXXTE00922 FAXXTE00925 FAXXTE00930 FAXXTE00932 FAXXTE00936 FAXXTE00939 FAXXTE00940 FAXXTE00945 FAXXTE00958 FAXXTE00961 FAXXTE00964 FAXXTE00970 FAXXTE00973 FAXXTE00979 FAXXTE00980 FAXXTE00983 FAXXTE00985 FAXXTE00987 FAXXTE00990 FAXXTE00993 FAXXTE00995 FAXXTE00996 FAXXTE00999 FAXXTE01006 FAXXTE01029 FAXXTE01030 FAXXTE01048 FAXXTE01053 FAXXTE01057 FAXXTE01064 FAXXTE01068 FAXXTE01084 FAXXTE01085 FAXXTE01086 FAXXTE01088 FAXXTE01089 FAXXTE01092 FAXXTE01114 FAXXTE01124 FAXXTE01139 FAXXTE01140 FAXXTE01141 FAXXTE01145 FAXXTE01154 FAXXTE01156 FAXXTE01159 FAXXTE01163 FAXXTE01166 FAXXTE01167 FAXXTE01168 FAXXTE01169 FAXXTE01171 FAXXTE01180 FAXXTE01183 FAXXTE01191 FAXXTE01193 FAXXTE01194 FAXXTE01195 FAXXTE01204 FAXXTE01205 FAXXTE01206 FAXXTE01210 FAXXTE01212 FAXXTE01219 FAXXTE01222 FAXXTP00003 FAXXTP00004 FAXXTP00007 FAXXTP00009 FAXXTP00010 FAXXTP00011 FAXXTP00012 FAXXTP00014 FAXXTP00018 FAXXTP00019 FAXXTP00020 FAXXXE00003 FAXXXE00004 FAXXXE00005 FAXXXE00007 FAXXXE00011 FAXXXE00012 FAXXXE00013 FAXXXE00017 FAXXXE00020 FAXXXE00021 FAXXXE00023 FAXXXE00024 FAXXXE00025 FAXXXE00026 FAXXXE00030 FAXXXE00032 FAXXXE00033 FAXXXE00036 FAXXXE00037 FAXXXE00038 FAXXXE00039 FAXXXE00043 FAXXXE00044 FAXXXE00045 FAXXXE00046 FAXXXE00047 FAXXXE00049 FAXXXE00053 FAXXXE00054 FAXXXE00056 FAXXXE00062 FAXXXE00071 FAXXXE00072 FAXXXE00076 FAXXXE00081 FAXXXE00082 FAXXXE00083 FAXXXE00085 FAXXXE00087 FAXXXE00091 FAXXXE00092 FAXXXE00093 FAXXXE00095 FAXXXE00096 FAXXXE00097 FAXXXE00098 FAXXXE00100 FAXXXE00105 FAXXXE00107 FAXXXE00109 FAXXXE00117 FAXXXE00120 FAXXXE00121 FAXXXE00124 FAXXXE00141 FAXXXE00147 FAXXXE00152 FAXXXE00155 FAXXXE00159 FAXXXE00164 FAXXXE00165 FAXXXE00167 FAXXXE00172 FAXXXE00174 FAXXXE00176 FAXXXE00180 FAXXXE00181 FAXXXE00183 FAXXXE00184 FAXXXE00185 FAXXXE00188 FAXXXE00196 FAXXXE00197 FAXXXE00198 FAXXXE00199 FAXXXE00200 FAXXXE00204 FAXXXE00206 FAXXXE00208 FAXXXE00210 FAXXXE00215 FAXXXE00217 FAXXXE00218 FAXXXE00222 FAXXXE00225 FAXXXE00227 FAXXXE00228 FAXXXE00229 FAXXXE00230 FAXXXE00231 FAXXXE00232 FAXXXE00235 FAXXXE00236 FAXXXE00238 FAXXXE00240 FAXXXE00244 FAXXXE00247 FAXXXE00251 FAXXXE00253 FAXXXE00254 FAXXXE00255 FAXXXE00256 FAXXXE00257 FAXXXE00261 FAXXXE00269 FAXXXE00270 FAXXXE00273 FAXXXE00275 FAXXXE00278 FAXXXE00279 FAXXXE00280 FAXXXE00282 FAXXXE00283 FAXXXE00287 FAXXXE00288 FAXXXE00290 FAXXXE00291 FAXXXE00292 FAXXXE00296 FAXXXE00297 FAXXXE00302 FAXXXE00303 FAXXXE00306 FAXXXE00312 FAXXXE00314 FAXXXE00315 FAXXXE00318 FAXXXE00319 FAXXXE00320 FAXXXE00321 FAXXXE00324 FAXXXE00325 FAXXXE00327 FAXXXE00328 FAXXXE00329 FAXXXE00330 FAXXXE00332 FAXXXE00335 FAXXXE00336 FAXXXE00339 FAXXXE00340 FAXXXE00343 FAXXXE00345 FAXXXE00346 FAXXXE00348 FAXXXE00354 FAXXXE00356 FAXXXE00359 FAXXXX00014 FAXXXX00020 FBHVXX00037 FBHVXX00040 FBHXTX00002 FBHXTX00006 FBHXTX00007 FBHXTX00009 FBHXTX00010 FBHXTX00011 FBHXTX00013 FBHXTX00019 FBHXTX00020 FBHXTX00021 FBHXTX00022 FBHXTX00023 FBHXTX00024 FBHXTX00025 FBHXTX00026 FBHXTX00031 FBHXTX00032 FBHXTX00033 FBHXTX00035 FBHXTX00038 FBHXTX00045 FBHXTX00047 FBHXTX00048 FBHXTX00051 FBHXTX00057 FBHXTX00059 FBHXTX00062 FBHXTX00068 FBHXTX00070 FBHXTX00071 FBHXTX00074 FBHXTX00079 FBHXTX00080 FBHXTX00081 FBHXTX00095 FBHXTX00098 FBHXTX00102 FBHXTX00103 FBHXTX00104 FBHXTX00106 FBHXTX00114 FBHXTX00115 FBHXTX00125 FBHXTX00126 FBHXTX00128 FBHXTX00130 FBHXTX00137 FBHXTX00144 FBHXTX00149 FBHXTX00151 FBHXTX00154 FBHXTX00159 FBHXTX00161 FBHXTX00163 FBHXTX00172 FBHXTX00173 FBHXTX00177 FBHXTX00184 FBHXTX00198 FBHXTX00199 FBHXTX00201 FBHXTX00203 FBHXTX00204 FBHXTX00205 FBHXTX00208 FBHXTX00210 FBHXTX00218 FBHXTX00223 FBHXTX00231 FBHXTX00233 FBHXTX00234 FBHXTX00235 FBHXTX00237 FBHXTX00241 FBHXTX00261 FBHXTX00266 FBHXTX00274 FBHXTX00275 FBHXTX00276 FBHXTX00277 FBHXTX00278 FBHXTX00279 FBHXTX00281 FBHXTX00282 FBHXTX00287 FBHXTX00290 FBHXTX00295 FBHXTX00316 FBHXTX00317 FBHXTX00319 FBHXTX00320 FBHXTX00324 FBHXTX00330 FBHXTX00335 FBHXTX00336 FBHXTX00337 FBHXTX00338 FBHXTX00339 FBHXTX00343 FBHXTX00344 FBHXTX00345 FBHXTX00348 FBHXTX00349 FBHXTX00350 FBHXTX00351 FBHXTX00352 FBHXTX00353 FBHXTX00354 FBHXTX00355 FBHXTX00356 FBHXTX00357 FBHXTX00360 FBHXTX00361 FBHXTX00362 FBHXTX00365 FBHXTX00366 FBHXTX00368 FBHXTX00369 FBHXTX00371 FBHXTX00375 FBHXTX00379 FBHXTX00381 FBHXTX00411 FBHXTX00415 FBHXTX00416 FBHXTX00417 FBHXTX00429 FBHXTX00431 FBHXTX00432 FBHXTX00433 FBHXTX00436 FBHXTX00438 FBHXTX00442 FBHXTX00444 FBHXTX00447 FBHXTX00448 FBHXTX00451 FBHXTX00458 FBHXTX00462 FBHXTX00468 FBHXTX00479 FBHXTX00482 FBHXTX00490 FBHXTX00491 FBHXTX00493 FBHXTX00498 FBHXTX00499 FBHXTX00500 FBHXTX00501 FBHXTX00503 FBHXTX00504 FBHXTX00505 FBHXTX00507 FBHXTX00508 FBHXTX00509 FBHXTX00510 FBHXTX00514 FBHXTX00516 FBHXTX00520 FBHXTX00524 FBHXTX00529 FBHXTX00535 FBHXTX00537 FBHXTX00541 FBHXT...

Label field

Details supplied by the agency

Lot, code or applicability

Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097 FAHXTX00110 FAHXTX00111 FAHXTX00112 FAHXTX00114 FAHXTX00115 FAHXTX00116 FAHXTX00117 FAHXTX00118 FAHXTX00119 FAHXTX00120 FAHXTX00121 FAHXTX00122 FAHXTX00124 FAHXTX00125 FAHXTX00135 FAHXTX00137 FAHXTX00138 FAHXTX00151 FAHXTX00152 FAHXTX00155 FAHXTX00156 FAHXTX00162 FAHXTX00163 FAHXTX00166 FAHXTX00170 FAHXTX00171 FAHXTX00177 FAHXTX00178 FAHXTX00188 FAHXTX00192 FAHXTX00193 FAHXTX00202 FAHXTX00204 FAHXTX00211 FAHXTX00212 FAHXTX00217 FAHXTX00219 FAHXTX00220 FAHXTX00221 FAHXTX00222 FAHXTX00223 FAHXTX00224 FAHXTX00226 FAHXTX00227 FAHXTX00229 FAHXTX00230 FAHXTX00236 FAHXTX00240 FAHXTX00244 FAHXTX00261 FAHXTX00265 FAHXTX00266 FAHXTX00269 FAHXTX00271 FAHXTX00272 FAHXTX00273 FAHXTX00274 FAHXTX00280 FAHXTX00283 FAHXTX00284 FAHXTX00296 FAHXTX00299 FAHXTX00300 FAHXTX00304 FAHXTX00305 FAHXTX00308 FAHXTX00312 FAHXTX00313 FAHXTX00320 FAHXTX00323 FAHXTX00325 FAHXTX00332 FAHXTX00340 FAHXTX00342 FAHXTX00343 FAHXTX00352 FAHXTX00353 FAHXTX00354 FAHXTX00357 FAHXTX00358 FAHXTX00359 FAHXTX00360 FAHXTX00363 FAHXTX00376 FAHXTX00379 FAHXTX00381 FAHXTX00382 FAHXTX00390 FAHXTX00392 FAHXTX00399 FAHXTX00400 FAHXTX00410 FAHXTX00413 FAHXTX00414 FAHXTX00415 FAHXTX00420 FAHXTX00421 FAHXTX00429 FAHXTX00439 FAHXTX00453 FAHXTX00455 FAHXTX00456 FAHXTX00463 FAHXTX00465 FAHXTX00466 FAHXTX00479 FAHXTX00481 FAHXTX00483 FAHXTX00484 FAHXTX00486 FAHXTX00488 FAHXTX00495 FAHXTX00497 FAHXTX00498 FAHXTX00507 FAHXTX00509 FAHXTX00513 FAHXTX00523 FAHXTX00530 FAHXTX00534 FAHXTX00538 FAHXTX00539 FAHXTX00540 FAHXTX00547 FAHXTX00549 FAHXTX00555 FAHXTX00557 FAHXTX00560 FAHXTX00565 FAHXTX00569 FAHXTX00570 FAHXTX00571 FAHXTX00572 FAHXTX00575 FAHXTX00576 FAHXTX00579 FAHXTX00592 FAHXTX00595 FAHXTX00610 FAHXTX00611 FAHXXX00029 FAHXXX00030 FAHXXX00038 FAHXXX00040 FAHXXX00056 FAHXXX00057 FAHXXX00059 FAHXXX00060 FAHXXX00061 FAHXXX00069 FAHXXX00082 FAHXXX00085 FAHXXX00086 FAHXXX00089 FAHXXX00091 FAHXXX00093 FAHXXX00097 FAHXXX00098 FAHXXX00099 FAHXXX00105 FAHXXX00106 FAHXXX00112 FAHXXX00113 FAHXXX00114 FAHXXX00116 FAHXXX00117 FAHXXX00119 FAHXXX00123 FAHXXX00142 FAHXXX00144 FAHXXX00145 FAHXXX00147 FAHXXX00150 FAHXXX00151 FAHXXX00153 FAHXXX00155 FAHXXX00164 FAHXXX00173 FAHXXX00176 FAHXXX00178 FAHXXX00179 FAHXXX00188 FAHXXX00190 FAHXXX00193 FAHXXX00196 FAHXXX00199 FAHXXX00200 FAHXXX00207 FAHXXX00208 FAHXXX00209 FAMHTX00001 FAMHTX00005 FAMHTX00007 FAMHTX00012 FAMHTX00014 FAMHTX00041 FAMHTX00051 FAMHTX00055 FAMHTX00064 FAMHTX00069 FAMHTX00081 FAMHTX00085 FAMHXX00003 FAMHXX00011 FAMHXX00019 FAMHXX00023 FAXXTE00003 FAXXTE00006 FAXXTE00009 FAXXTE00011 FAXXTE00013 FAXXTE00014 FAXXTE00015 FAXXTE00017 FAXXTE00021 FAXXTE00022 FAXXTE00024 FAXXTE00025 FAXXTE00028 FAXXTE00031 FAXXTE00032 FAXXTE00033 FAXXTE00034 FAXXTE00035 FAXXTE00037 FAXXTE00038 FAXXTE00039 FAXXTE00040 FAXXTE00044 FAXXTE00046 FAXXTE00047 FAXXTE00049 FAXXTE00050 FAXXTE00051 FAXXTE00052 FAXXTE00056 FAXXTE00062 FAXXTE00063 FAXXTE00064 FAXXTE00067 FAXXTE00071 FAXXTE00072 FAXXTE00073 FAXXTE00076 FAXXTE00084 FAXXTE00085 FAXXTE00091 FAXXTE00092 FAXXTE00094 FAXXTE00095 FAXXTE00099 FAXXTE00100 FAXXTE00101 FAXXTE00104 FAXXTE00105 FAXXTE00106 FAXXTE00107 FAXXTE00109 FAXXTE00110 FAXXTE00114 FAXXTE00116 FAXXTE00117 FAXXTE00120 FAXXTE00121 FAXXTE00128 FAXXTE00129 FAXXTE00134 FAXXTE00136 FAXXTE00137 FAXXTE00141 FAXXTE00144 FAXXTE00145 FAXXTE00147 FAXXTE00149 FAXXTE00163 FAXXTE00164 FAXXTE00170 FAXXTE00173 FAXXTE00175 FAXXTE00179 FAXXTE00180 FAXXTE00182 FAXXTE00184 FAXXTE00185 FAXXTE00195 FAXXTE00197 FAXXTE00205 FAXXTE00212 FAXXTE00220 FAXXTE00224 FAXXTE00225 FAXXTE00227 FAXXTE00228 FAXXTE00229 FAXXTE00230 FAXXTE00231 FAXXTE00234 FAXXTE00236 FAXXTE00237 FAXXTE00238 FAXXTE00240 FAXXTE00241 FAXXTE00243 FAXXTE00246 FAXXTE00248 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FBHXTX00159 FBHXTX00161 FBHXTX00163 FBHXTX00172 FBHXTX00173 FBHXTX00177 FBHXTX00184 FBHXTX00198 FBHXTX00199 FBHXTX00201 FBHXTX00203 FBHXTX00204 FBHXTX00205 FBHXTX00208 FBHXTX00210 FBHXTX00218 FBHXTX00223 FBHXTX00231 FBHXTX00233 FBHXTX00234 FBHXTX00235 FBHXTX00237 FBHXTX00241 FBHXTX00261 FBHXTX00266 FBHXTX00274 FBHXTX00275 FBHXTX00276 FBHXTX00277 FBHXTX00278 FBHXTX00279 FBHXTX00281 FBHXTX00282 FBHXTX00287 FBHXTX00290 FBHXTX00295 FBHXTX00316 FBHXTX00317 FBHXTX00319 FBHXTX00320 FBHXTX00324 FBHXTX00330 FBHXTX00335 FBHXTX00336 FBHXTX00337 FBHXTX00338 FBHXTX00339 FBHXTX00343 FBHXTX00344 FBHXTX00345 FBHXTX00348 FBHXTX00349 FBHXTX00350 FBHXTX00351 FBHXTX00352 FBHXTX00353 FBHXTX00354 FBHXTX00355 FBHXTX00356 FBHXTX00357 FBHXTX00360 FBHXTX00361 FBHXTX00362 FBHXTX00365 FBHXTX00366 FBHXTX00368 FBHXTX00369 FBHXTX00371 FBHXTX00375 FBHXTX00379 FBHXTX00381 FBHXTX00411 FBHXTX00415 FBHXTX00416 FBHXTX00417 FBHXTX00429 FBHXTX00431 FBHXTX00432 FBHXTX00433 FBHXTX00436 FBHXTX00438 FBHXTX00442 FBHXTX00444 FBHXTX00447 FBHXTX00448 FBHXTX00451 FBHXTX00458 FBHXTX00462 FBHXTX00468 FBHXTX00479 FBHXTX00482 FBHXTX00490 FBHXTX00491 FBHXTX00493 FBHXTX00498 FBHXTX00499 FBHXTX00500 FBHXTX00501 FBHXTX00503 FBHXTX00504 FBHXTX00505 FBHXTX00507 FBHXTX00508 FBHXTX00509 FBHXTX00510 FBHXTX00514 FBHXTX00516 FBHXTX00520 FBHXTX00524 FBHXTX00529 FBHXTX00535 FBHXTX00537 FBHXTX00541 FBHXT...

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 and OUS

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Jun 18, 2025
Recall initiation date: Mar 21, 2025
Center classification date: Jun 9, 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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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