Recall archive / FDA device enforcement

FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch scre... — FDA record Z-0353-2024

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 Oct 17, 2023. 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: FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.
Reason: Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.
Classification: Class II
Recalling firm: BioFire Diagnostics, LLC
Quantity: 5,406 systems
Agency-reported status: Ongoing
Source record identifier: Z-0353-2024

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	Model/Part Number: HTFA-ASY-0104 UDI-DI Code: 00815381020253 Serial Numbers: All serial numbers (listed below) U.S. KTB00006 KTB00007 KTB00008 KTB00009 KTB00011 KTB00012 KTB00014 KTB00015 KTB00016 KTB00017 KTB00018 KTB00019 KTB00020 KTB00021 KTB00022 KTB00023 KTB00025 KTB00026 KTB00027 KTB00029 KTB00030 KTB00031 KTB00032 KTB00033 KTB00034 KTB00035 KTB00036 KTB00037 KTB00038 KTB00039 KTB00040 KTB00041 KTB00044 KTB00045 KTB00046 KTB00053 KTB00056 KTB00058 KTB00059 KTB00060 KTB00061 KTB00062 KTB00063 KTB00064 KTB00065 KTB00066 KTB00068 KTB00069 KTB00070 KTB00071 KTB00072 KTB00073 KTB00074 KTB00075 KTB00076 KTB00077 KTB00078 KTB00079 KTB00082 KTB00083 KTB00084 KTB00085 KTB00086 KTB00087 KTB00088 KTB00089 KTB00090 KTB00091 KTB00092 KTB00093 KTB00094 KTB00095 KTB00101 KTB00105 KTB00107 KTB00108 KTB00110 KTB00119 KTB00120 KTB00121 KTB00122 KTB00123 KTB00124 KTB00125 KTB00126 KTB00128 KTB00129 KTB00130 KTB00131 KTB00132 KTB00133 KTB00134 KTB00135 KTB00136 KTB00137 KTB00139 KTB00140 KTB00142 KTB00143 KTB00144 KTB00145 KTB00146 KTB00147 KTB00148 KTB00149 KTB00150 KTB00151 KTB00152 KTB00154 KTB00155 KTB00159 KTB00160 KTB00161 KTB00163 KTB00165 KTB00173 KTB00174 KTB00175 KTB00177 KTB00178 KTB00179 KTB00182 KTB00183 KTB00184 KTB00185 KTB00186 KTB00187 KTB00188 KTB00189 KTB00190 KTB00191 KTB00193 KTB00194 KTB00195 KTB00196 KTB00197 KTB00199 KTB00200 KTB00201 KTB00202 KTB00203 KTB00205 KTB00206 KTB00209 KTB00211 KTB00212 KTB00213 KTB00215 KTB00219 KTB00220 KTB00221 KTB00222 KTB00223 KTB00224 KTB00225 KTB00226 KTB00227 KTB00228 KTB00229 KTB00230 KTB00232 KTB00233 KTB00234 KTB00235 KTB00236 KTB00237 KTB00238 KTB00240 KTB00243 KTB00244 KTB00246 KTB00247 KTB00248 KTB00249 KTB00250 KTB00251 KTB00252 KTB00253 KTB00254 KTB00255 KTB00256 KTB00257 KTB00258 KTB00259 KTB00260 KTB00261 KTB00262 KTB00263 KTB00264 KTB00265 KTB00266 KTB00267 KTB00268 KTB00269 KTB00270 KTB00271 KTB00272 KTB00273 KTB00274 KTB00275 KTB00276 KTB00277 KTB00278 KTB00279 KTB00280 KTB00281 KTB00282 KTB00283 KTB00284 KTB00285 KTB00286 KTB00287 KTB00289 KTB00290 KTB00291 KTB00292 KTB00293 KTB00294 KTB00295 KTB00296 KTB00297 KTB00298 KTB00299 KTB00302 KTB00303 KTB00305 KTB00306 KTB00307 KTB00308 KTB00309 KTB00310 KTB00312 KTB00313 KTB00314 KTB00316 KTB00317 KTB00318 KTB00319 KTB00320 KTB00322 KTB00323 KTB00324 KTB00326 KTB00328 KTB00329 KTB00330 KTB00331 KTB00332 KTB00333 KTB00334 KTB00336 KTB00337 KTB00338 KTB00339 KTB00340 KTB00341 KTB00342 KTB00344 KTB00347 KTB00348 KTB00349 KTB00351 KTB00352 KTB00353 KTB00355 KTB00356 KTB00357 KTB00358 KTB00361 KTB00362 KTB00366 KTB00367 KTB00369 KTB00370 KTB00371 KTB00372 KTB00374 KTB00377 KTB00378 KTB00379 KTB00380 KTB00381 KTB00382 KTB00383 KTB00386 KTB00387 KTB00389 KTB00390 KTB00391 KTB00394 KTB00395 KTB00396 KTB00397 KTB00398 KTB00399 KTB00400 KTB00404 KTB00408 KTB00409 KTB00410 KTB00411 KTB00412 KTB00413 KTB00414 KTB00415 KTB00419 KTB00422 KTB00423 KTB00424 KTB00425 KTB00427 KTB00428 KTB00429 KTB00431 KTB00432 KTB00433 KTB00434 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KTB02476 KTB02477 KTB02478 KTB02479 K...

Label field

Details supplied by the agency

Lot, code or applicability

Model/Part Number: HTFA-ASY-0104 UDI-DI Code: 00815381020253 Serial Numbers: All serial numbers (listed below) U.S. KTB00006 KTB00007 KTB00008 KTB00009 KTB00011 KTB00012 KTB00014 KTB00015 KTB00016 KTB00017 KTB00018 KTB00019 KTB00020 KTB00021 KTB00022 KTB00023 KTB00025 KTB00026 KTB00027 KTB00029 KTB00030 KTB00031 KTB00032 KTB00033 KTB00034 KTB00035 KTB00036 KTB00037 KTB00038 KTB00039 KTB00040 KTB00041 KTB00044 KTB00045 KTB00046 KTB00053 KTB00056 KTB00058 KTB00059 KTB00060 KTB00061 KTB00062 KTB00063 KTB00064 KTB00065 KTB00066 KTB00068 KTB00069 KTB00070 KTB00071 KTB00072 KTB00073 KTB00074 KTB00075 KTB00076 KTB00077 KTB00078 KTB00079 KTB00082 KTB00083 KTB00084 KTB00085 KTB00086 KTB00087 KTB00088 KTB00089 KTB00090 KTB00091 KTB00092 KTB00093 KTB00094 KTB00095 KTB00101 KTB00105 KTB00107 KTB00108 KTB00110 KTB00119 KTB00120 KTB00121 KTB00122 KTB00123 KTB00124 KTB00125 KTB00126 KTB00128 KTB00129 KTB00130 KTB00131 KTB00132 KTB00133 KTB00134 KTB00135 KTB00136 KTB00137 KTB00139 KTB00140 KTB00142 KTB00143 KTB00144 KTB00145 KTB00146 KTB00147 KTB00148 KTB00149 KTB00150 KTB00151 KTB00152 KTB00154 KTB00155 KTB00159 KTB00160 KTB00161 KTB00163 KTB00165 KTB00173 KTB00174 KTB00175 KTB00177 KTB00178 KTB00179 KTB00182 KTB00183 KTB00184 KTB00185 KTB00186 KTB00187 KTB00188 KTB00189 KTB00190 KTB00191 KTB00193 KTB00194 KTB00195 KTB00196 KTB00197 KTB00199 KTB00200 KTB00201 KTB00202 KTB00203 KTB00205 KTB00206 KTB00209 KTB00211 KTB00212 KTB00213 KTB00215 KTB00219 KTB00220 KTB00221 KTB00222 KTB00223 KTB00224 KTB00225 KTB00226 KTB00227 KTB00228 KTB00229 KTB00230 KTB00232 KTB00233 KTB00234 KTB00235 KTB00236 KTB00237 KTB00238 KTB00240 KTB00243 KTB00244 KTB00246 KTB00247 KTB00248 KTB00249 KTB00250 KTB00251 KTB00252 KTB00253 KTB00254 KTB00255 KTB00256 KTB00257 KTB00258 KTB00259 KTB00260 KTB00261 KTB00262 KTB00263 KTB00264 KTB00265 KTB00266 KTB00267 KTB00268 KTB00269 KTB00270 KTB00271 KTB00272 KTB00273 KTB00274 KTB00275 KTB00276 KTB00277 KTB00278 KTB00279 KTB00280 KTB00281 KTB00282 KTB00283 KTB00284 KTB00285 KTB00286 KTB00287 KTB00289 KTB00290 KTB00291 KTB00292 KTB00293 KTB00294 KTB00295 KTB00296 KTB00297 KTB00298 KTB00299 KTB00302 KTB00303 KTB00305 KTB00306 KTB00307 KTB00308 KTB00309 KTB00310 KTB00312 KTB00313 KTB00314 KTB00316 KTB00317 KTB00318 KTB00319 KTB00320 KTB00322 KTB00323 KTB00324 KTB00326 KTB00328 KTB00329 KTB00330 KTB00331 KTB00332 KTB00333 KTB00334 KTB00336 KTB00337 KTB00338 KTB00339 KTB00340 KTB00341 KTB00342 KTB00344 KTB00347 KTB00348 KTB00349 KTB00351 KTB00352 KTB00353 KTB00355 KTB00356 KTB00357 KTB00358 KTB00361 KTB00362 KTB00366 KTB00367 KTB00369 KTB00370 KTB00371 KTB00372 KTB00374 KTB00377 KTB00378 KTB00379 KTB00380 KTB00381 KTB00382 KTB00383 KTB00386 KTB00387 KTB00389 KTB00390 KTB00391 KTB00394 KTB00395 KTB00396 KTB00397 KTB00398 KTB00399 KTB00400 KTB00404 KTB00408 KTB00409 KTB00410 KTB00411 KTB00412 KTB00413 KTB00414 KTB00415 KTB00419 KTB00422 KTB00423 KTB00424 KTB00425 KTB00427 KTB00428 KTB00429 KTB00431 KTB00432 KTB00433 KTB00434 KTB00435 KTB00436 KTB00439 KTB00441 KTB00442 KTB00443 KTB00444 KTB00445 KTB00446 KTB00448 KTB00449 KTB00450 KTB00452 KTB00453 KTB00468 KTB00470 KTB00471 KTB00474 KTB00477 KTB00478 KTB00480 KTB00481 KTB00482 KTB00483 KTB00485 KTB00487 KTB00489 KTB00490 KTB00491 KTB00493 KTB00494 KTB00495 KTB00496 KTB00497 KTB00498 KTB00499 KTB00501 KTB00502 KTB00504 KTB00505 KTB00506 KTB00507 KTB00508 KTB00509 KTB00511 KTB00512 KTB00513 KTB00514 KTB00515 KTB00516 KTB00518 KTB00521 KTB00522 KTB00523 KTB00524 KTB00525 KTB00526 KTB00530 KTB00532 KTB00533 KTB00534 KTB00535 KTB00536 KTB00538 KTB00539 KTB00540 KTB00541 KTB00542 KTB00543 KTB00545 KTB00546 KTB00549 KTB00551 KTB00552 KTB00553 KTB00554 KTB00555 KTB00556 KTB00558 KTB00559 KTB00562 KTB00563 KTB00564 KTB00566 KTB00567 KTB00568 KTB00569 KTB00570 KTB00571 KTB00573 KTB00574 KTB00576 KTB00577 KTB00578 KTB00579 KTB00580 KTB00581 KTB00582 KTB00583 KTB00584 KTB00585 KTB00586 KTB00587 KTB00588 KTB00589 KTB00590 KTB00591 KTB00593 KTB00594 KTB00595 KTB00596 KTB00597 KTB00598 KTB00599 KTB00600 KTB00601 KTB00602 KTB00603 KTB00604 KTB00605 KTB00608 KTB00609 KTB00610 KTB00611 KTB00612 KTB00613 KTB00614 KTB00617 KTB00621 KTB00622 KTB00623 KTB00624 KTB00626 KTB00627 KTB00632 KTB00633 KTB00634 KTB00637 KTB00638 KTB00639 KTB00640 KTB00641 KTB00642 KTB00654 KTB00655 KTB00657 KTB00659 KTB00661 KTB00663 KTB00664 KTB00665 KTB00669 KTB00670 KTB00671 KTB00672 KTB00673 KTB00674 KTB00675 KTB00679 KTB00680 KTB00681 KTB00683 KTB00684 KTB00685 KTB00688 KTB00699 KTB00700 KTB00704 KTB00705 KTB00706 KTB00707 KTB00708 KTB00711 KTB00712 KTB00722 KTB00729 KTB00743 KTB00744 KTB00745 KTB00746 KTB00747 KTB00748 KTB00749 KTB00753 KTB00754 KTB00755 KTB00756 KTB00757 KTB00758 KTB00762 KTB00763 KTB00764 KTB00765 KTB00766 KTB00767 KTB00768 KTB00769 KTB00770 KTB00771 KTB00772 KTB00774 KTB00779 KTB00780 KTB00783 KTB00786 KTB00787 KTB00788 KTB00789 KTB00791 KTB00792 KTB00793 KTB00794 KTB00797 KTB00799 KTB00800 KTB00807 KTB00808 KTB00809 KTB00810 KTB00811 KTB00815 KTB00817 KTB00818 KTB00819 KTB00821 KTB00827 KTB00830 KTB00831 KTB00832 KTB00836 KTB00837 KTB00838 KTB00841 KTB00842 KTB00844 KTB00845 KTB00847 KTB00848 KTB00849 KTB00855 KTB00856 KTB00858 KTB00860 KTB00865 KTB00867 KTB00870 KTB00873 KTB00874 KTB00875 KTB00877 KTB00878 KTB00879 KTB00880 KTB00883 KTB00884 KTB00885 KTB00892 KTB00893 KTB00894 KTB00895 KTB00896 KTB00897 KTB00898 KTB00899 KTB00900 KTB00902 KTB00905 KTB00906 KTB00909 KTB00911 KTB00916 KTB00917 KTB00918 KTB00919 KTB00920 KTB00922 KTB00924 KTB00925 KTB00926 KTB00927 KTB00928 KTB00929 KTB00930 KTB00935 KTB00937 KTB00938 KTB00939 KTB00940 KTB00942 KTB00944 KTB00947 KTB00948 KTB00949 KTB00950 KTB00952 KTB00957 KTB00958 KTB00959 KTB00960 KTB00961 KTB00963 KTB00964 KTB00965 KTB00966 KTB00967 KTB00969 KTB00971 KTB00972 KTB00973 KTB00975 KTB00976 KTB00978 KTB00979 KTB00982 KTB00984 KTB00988 KTB00989 KTB00992 KTB00993 KTB00994 KTB00995 KTB00997 KTB00999 KTB01000 KTB01002 KTB01003 KTB01004 KTB01005 KTB01006 KTB01008 KTB01009 KTB01017 KTB01018 KTB01020 KTB01022 KTB01026 KTB01027 KTB01033 KTB01034 KTB01044 KTB01045 KTB01046 KTB01048 KTB01049 KTB01050 KTB01051 KTB01054 KTB01055 KTB01056 KTB01057 KTB01058 KTB01059 KTB01061 KTB01062 KTB01063 KTB01064 KTB01065 KTB01067 KTB01069 KTB01070 KTB01072 KTB01073 KTB01074 KTB01076 KTB01077 KTB01078 KTB01079 KTB01081 KTB01082 KTB01083 KTB01085 KTB01086 KTB01087 KTB01089 KTB01090 KTB01091 KTB01092 KTB01094 KTB01095 KTB01096 KTB01097 KTB01099 KTB01106 KTB01110 KTB01113 KTB01115 KTB01119 KTB01124 KTB01125 KTB01127 KTB01133 KTB01135 KTB01137 KTB01138 KTB01142 KTB01149 KTB01152 KTB01153 KTB01154 KTB01155 KTB01156 KTB01157 KTB01164 KTB01166 KTB01167 KTB01169 KTB01171 KTB01172 KTB01177 KTB01178 KTB01179 KTB01181 KTB01182 KTB01183 KTB01184 KTB01185 KTB01186 KTB01187 KTB01188 KTB01189 KTB01190 KTB01191 KTB01192 KTB01193 KTB01194 KTB01195 KTB01196 KTB01197 KTB01198 KTB01199 KTB01200 KTB01202 KTB01203 KTB01204 KTB01205 KTB01206 KTB01207 KTB01208 KTB01209 KTB01211 KTB01212 KTB01213 KTB01214 KTB01215 KTB01216 KTB01217 KTB01218 KTB01223 KTB01224 KTB01225 KTB01229 KTB01230 KTB01231 KTB01233 KTB01234 KTB01235 KTB01236 KTB01238 KTB01239 KTB01240 KTB01241 KTB01244 KTB01248 KTB01249 KTB01252 KTB01253 KTB01262 KTB01265 KTB01266 KTB01268 KTB01270 KTB01271 KTB01273 KTB01274 KTB01276 KTB01280 KTB01281 KTB01287 KTB01297 KTB01299 KTB01300 KTB01301 KTB01302 KTB01303 KTB01305 KTB01306 KTB01308 KTB01311 KTB01318 KTB01319 KTB01324 KTB01326 KTB01327 KTB01328 KTB01329 KTB01332 KTB01333 KTB01341 KTB01343 KTB01344 KTB01345 KTB01346 KTB01347 KTB01348 KTB01349 KTB01350 KTB01351 KTB01352 KTB01353 KTB01354 KTB01355 KTB01356 KTB01358 KTB01360 KTB01361 KTB01364 KTB01368 KTB01372 KTB01373 KTB01377 KTB01380 KTB01381 KTB01382 KTB01383 KTB01384 KTB01385 KTB01386 KTB01388 KTB01389 KTB01392 KTB01393 KTB01394 KTB01395 KTB01396 KTB01397 KTB01398 KTB01399 KTB01400 KTB01401 KTB01402 KTB01403 KTB01404 KTB01405 KTB01406 KTB01407 KTB01408 KTB01409 KTB01411 KTB01412 KTB01416 KTB01424 KTB01425 KTB01426 KTB01428 KTB01429 KTB01430 KTB01431 KTB01432 KTB01433 KTB01434 KTB01435 KTB01439 KTB01440 KTB01441 KTB01442 KTB01443 KTB01444 KTB01445 KTB01449 KTB01451 KTB01459 KTB01460 KTB01461 KTB01462 KTB01463 KTB01464 KTB01468 KTB01478 KTB01479 KTB01482 KTB01484 KTB01486 KTB01487 KTB01488 KTB01493 KTB01495 KTB01499 KTB01504 KTB01505 KTB01507 KTB01508 KTB01510 KTB01511 KTB01512 KTB01514 KTB01515 KTB01518 KTB01525 KTB01534 KTB01536 KTB01544 KTB01545 KTB01546 KTB01547 KTB01549 KTB01552 KTB01560 KTB01561 KTB01563 KTB01565 KTB01571 KTB01581 KTB01585 KTB01586 KTB01587 KTB01595 KTB01596 KTB01600 KTB01606 KTB01608 KTB01610 KTB01611 KTB01613 KTB01614 KTB01621 KTB01631 KTB01632 KTB01633 KTB01634 KTB01635 KTB01636 KTB01637 KTB01638 KTB01639 KTB01640 KTB01641 KTB01642 KTB01643 KTB01644 KTB01645 KTB01646 KTB01647 KTB01648 KTB01652 KTB01654 KTB01658 KTB01661 KTB01663 KTB01664 KTB01665 KTB01666 KTB01667 KTB01668 KTB01669 KTB01670 KTB01671 KTB01673 KTB01674 KTB01675 KTB01676 KTB01677 KTB01678 KTB01683 KTB01684 KTB01685 KTB01686 KTB01688 KTB01689 KTB01691 KTB01692 KTB01694 KTB01696 KTB01697 KTB01699 KTB01700 KTB01701 KTB01702 KTB01703 KTB01710 KTB01713 KTB01714 KTB01715 KTB01717 KTB01719 KTB01720 KTB01721 KTB01728 KTB01737 KTB01738 KTB01739 KTB01740 KTB01741 KTB01743 KTB01744 KTB01745 KTB01746 KTB01747 KTB01748 KTB01749 KTB01750 KTB01752 KTB01753 KTB01755 KTB01757 KTB01759 KTB01769 KTB01770 KTB01771 KTB01772 KTB01773 KTB01775 KTB01777 KTB01778 KTB01779 KTB01781 KTB01785 KTB01786 KTB01787 KTB01790 KTB01791 KTB01792 KTB01793 KTB01794 KTB01795 KTB01802 KTB01804 KTB01834 KTB01835 KTB01836 KTB01837 KTB01838 KTB01839 KTB01846 KTB01847 KTB01849 KTB01858 KTB01859 KTB01860 KTB01861 KTB01862 KTB01863 KTB01864 KTB01865 KTB01867 KTB01868 KTB01876 KTB01877 KTB01879 KTB01880 KTB01881 KTB01903 KTB01904 KTB01905 KTB01906 KTB01907 KTB01908 KTB01942 KTB01950 KTB01951 KTB01952 KTB01953 KTB01954 KTB01955 KTB01956 KTB01957 KTB01958 KTB01959 KTB01960 KTB01961 KTB01962 KTB01963 KTB01964 KTB01965 KTB01966 KTB01967 KTB01968 KTB01969 KTB01970 KTB01971 KTB01972 KTB01973 KTB01974 KTB01975 KTB01976 KTB01977 KTB01978 KTB01979 KTB01980 KTB01981 KTB01982 KTB01983 KTB01984 KTB01985 KTB01992 KTB01993 KTB01994 KTB01ECA KTB02001 KTB02002 KTB02003 KTB02004 KTB02005 KTB02006 KTB02007 KTB02008 KTB02009 KTB02010 KTB02011 KTB02012 KTB02021 KTB02037 KTB02038 KTB02039 KTB02040 KTB02041 KTB02042 KTB02044 KTB02045 KTB02046 KTB02047 KTB02048 KTB02056 KTB02057 KTB02059 KTB02061 KTB02062 KTB02063 KTB02100 KTB02101 KTB02102 KTB02103 KTB02104 KTB02105 KTB02106 KTB02107 KTB02108 KTB02109 KTB02110 KTB02111 KTB02112 KTB02113 KTB02114 KTB02115 KTB02116 KTB02117 KTB02118 KTB02119 KTB02120 KTB02121 KTB02122 KTB02123 KTB02124 KTB02125 KTB02126 KTB02127 KTB02128 KTB02129 KTB02130 KTB02131 KTB02135 KTB02138 KTB02139 KTB02140 KTB02165 KTB02192 KTB02193 KTB02194 KTB02195 KTB02196 KTB02197 KTB02198 KTB02199 KTB02200 KTB02201 KTB02202 KTB02203 KTB02204 KTB02205 KTB02206 KTB02211 KTB02217 KTB02218 KTB02222 KTB02223 KTB02224 KTB02225 KTB02231 KTB02232 KTB02233 KTB02234 KTB02235 KTB02241 KTB02243 KTB02247 KTB02248 KTB02249 KTB02250 KTB02251 KTB02262 KTB02269 KTB02270 KTB02271 KTB02278 KTB02279 KTB02280 KTB02281 KTB02282 KTB02283 KTB02284 KTB02285 KTB02286 KTB02287 KTB02288 KTB02289 KTB02290 KTB02292 KTB02293 KTB02294 KTB02295 KTB02296 KTB02302 KTB02303 KTB02304 KTB02305 KTB02306 KTB02307 KTB02312 KTB02313 KTB02314 KTB02315 KTB02316 KTB02317 KTB02318 KTB02319 KTB02320 KTB02322 KTB02324 KTB02325 KTB02326 KTB02327 KTB02328 KTB02329 KTB02330 KTB02331 KTB02338 KTB02339 KTB02340 KTB02341 KTB02358 KTB02359 KTB02360 KTB02361 KTB02372 KTB02373 KTB02374 KTB02375 KTB02376 KTB02377 KTB02404 KTB02405 KTB02406 KTB02408 KTB02413 KTB02414 KTB02415 KTB02416 KTB02417 KTB02418 KTB02419 KTB02420 KTB02421 KTB02422 KTB02423 KTB02424 KTB02425 KTB02426 KTB02433 KTB02440 KTB02441 KTB02442 KTB02446 KTB02447 KTB02449 KTB02450 KTB02451 KTB02452 KTB02453 KTB02454 KTB02455 KTB02456 KTB02457 KTB02458 KTB02459 KTB02460 KTB02461 KTB02462 KTB02463 KTB02464 KTB02465 KTB02476 KTB02477 KTB02478 KTB02479 K...

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

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, N, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Philippines, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, United Arab Emirates.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Nov 29, 2023
Recall initiation date: Oct 17, 2023
Center classification date: Nov 20, 2023

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

Related records