Recall archive / FDA device enforcement

Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrill... — FDA record Z-2614-2023

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 Aug 16, 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: Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA300Q Entrant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.
Reason: Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Classification: Class II
Recalling firm: Abbott Medical
Quantity: 38,033 devices
Agency-reported status: Ongoing
Source record identifier: Z-2614-2023

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	Gallant: Model Number: VR ICD REF CDVRA500Q UDI-DI Code: 05415067031990 Serial Numbers: 111033498 810000696 810002524 111031208 111025117 111030959 111006327 111028481 111014296 111033775 810021414 810001946 810001996 810002011 810001942 810007459 111036536 810019608 810019393 810019581 111042257 810026722 810028531 810028585 810027003 111011936 810021423 111025530 111015227 111036960 810026790 111036957 111036933 111036964 111007506 810021413 810021445 810021449 111033604 111000553 111000558 111000567 111000472 111000706 111000667 111006793 111000664 111000678 111018664 111018644 111018802 111012460 111006783 111006791 111006789 111000786 111000582 111000550 111000721 111001035 111001025 111014950 111021456 111021461 111021703 111021722 111021450 111036417 111012272 111011597 810001013 810001011 810006759 810001046 810001021 810019014 111024417 810002439 111024415 810006774 111024454 810022318 111036914 810013066 810015963 111002002 810021662 810013192 810011364 111003380 810011481 111020960 111011436 111020992 810015820 810015794 111009835 111004271 111003046 111024175 111022969 111009840 810019313 810018954 111021002 111009844 810008620 111010818 810018999 111021710 810016110 810019437 810008498 111024550 810008497 810019426 810011359 810019424 810011511 810011353 810011328 111011181 111011372 111021007 111021712 111024183 810013436 810019054 810019546 810022117 810027515 810013071 810007469 111020996 111009733 111003861 111009782 810011335 810016103 111021851 810004570 111008584 111009245 111003267 810008499 111021988 111012318 111003040 111010800 111003332 111022768 810016526 810027041 111009747 810013248 111011899 111010457 810021351 810021705 810015780 111018656 111010771 111021437 810005318 111010761 111022974 111021994 810007454 810008483 810011285 810011458 810005317 111008582 111003173 111008588 111003555 111018654 810027111 810019552 810016459 111009820 810008557 810026959 111002712 111021707 111006776 111006779 111010814 111017230 810021576 810016112 111003506 810027040 810027014 810003350 111009781 111018131 810021674 111011908 810008527 810019917 111008583 810008575 111004282 810016339 810027099 810015815 810016102 111002437 111011229 111018270 810021707 810013068 810013216 810015840 810018976 810021355 810011459 111003500 111019459 810003430 111009834 111010787 111000447 111004193 111009841 111013996 111011233 111011254 111021837 111019423 810011451 111018786 810016113 810016649 810013446 810013250 810013442 810027039 810026943 810026944 810027020 810027165 111009759 111006801 111021440 111010437 111019431 810011457 810016665 810016449 810019012 810021618 810008573 810021560 810011535 111009788 810013454 810008650 810015824 111006778 810005319 111024379 810013349 810004013 111009809 810008519 111024368 810003553 111024378 111006784 810016140 810008486 111006797 810013266 111018109 111018795 111022789 111011910 810021606 810007463 810007421 810003677 111011216 810027514 111018640 810019556 810008612 111018784 111024402 810003437 810011343 810008526 111004721 111021995 810027548 810018995 810016138 810019427 810005706 111022585 810011387 111018291 111011963 111009708 111010450 111017239 111022090 111024180 111011906 111021723 111021436 810022090 810015784 111009794 111021433 810003343 810013241 111010980 810027103 111011915 111002410 810027161 111001995 111009741 111006541 111002011 810016121 111004259 111003960 810021559 111024204 810013232 111016740 810027168 810015796 111001027 111012290 111002434 111010962 111001969 810015822 111016745 111024202 111012258 111010952 111024184 111013804 111022788 111010465 810019529 810011303 111013808 810011549 810011538 111021812 810005366 810007473 111023732 111014948 111013807 111001583 111023720 111022587 111011938 810026979 111012462 111012307 111003869 111024186 810016277 111004242 810005286 111022781 111021845 810004846 810015783 111019446 810022064 111010799 111011214 810022363 111009828 810008597 111021790 111003559 810016560 111011185 810013225 111013993 810013206 111011922 111003276 810018982 111003858 810013077 810011449 810011550 810016303 111011237 111019415 111003865 111006785 111003863 111004182 111021466 810004849 111012256 111006775 810022137 810019296 810019297 111018120 111018679 810003615 810008594 111003065 111003037 810022370 810022129 810019042 111004513 111003074 111022971 111003957 810005356 111004518 111023531 111003371 111014919 111009837 111003539 111002743 810019250 810011523 810019254 111021846 111022077 810021666 810022122 810021671 810019272 810019301 810019290 810019278 810019065 810019325 810019408 810019310 810019293 810019009 111009737 111011215 111009766 111009777 111003521 111010981 111011968 111009261 111003686 111017247 111017245 111003567 111003505 810015772 810015773 111004497 111017234 810013185 810019050 810011339 810022145 810022376 810022079 810022078 810021530 810021687 810021563 810018946 810019017 810016151 810027033 810013203 810011349 810011369 810008563 810004696 111021010 111024381 111024199 111020974 111019443 111022093 111022955 810016344 810016656 810016653 810016532 111011363 111008706 111003365 111003283 111000464 111003963 810019260 111004523 111004267 810013197 810022087 810011461 810022126 810016310 111003691 111003350 810007437 111021445 111003695 810013245 111000473 111011969 111012312 810013196 810011305 810015962 111017246 810016105 810011298 810027536 810011487 111012295 810027150 111012279 810016644 111024214 111018263 111018111 111000666 111000560 111011981 111000658 810027036 111020994 111009262 810005321 111011380 111003688 111003510 810021545 810005705 810005253 810005296 111022085 111024394 810003454 111018643 810018983 111011603 111011367 111000462 111021429 810013477 810022094 810019059 111010780 810013451 111021843 810013458 810019282 111000541 111021815 810011470 810008640 111000757 810011337 810016363 810021520 111000792 111003514 111000441 111021811 810011358 810027159 810016146 810019063 810019539 810022082 111021717 810011295 111024398 111000440 810015797 810015800 810013448 810016145 810016322 810019268 810021602 810021664 111001076 111004164 810007406 111011247 111011227 111011226 111010454 111010436 111010773 111010448 810022110 111024549 111024380 111021824 810022096 810008474 810007403 810007413 810007434 111021000 810026542 810016270 810018953 810026999 810007427 810008536 810008637 810019443 810021702 111008602 810005709 111021724 810005279 111012296 111000803 111003508 111004172 111000996 111020952 111014955 810018966 111001082 810016155 810018955 810018996 111003680 810019057 810016524 810016334 810019019 810018980 111009773 810021369 810019524 810019525 810021376 111022089 111011375 111024197 810019441 810019442 810007414 810008607 810021578 810008595 810022141 810008591 810008603 810021616 810007416 111000150 810019010 810011503 810022107 810007410 810016323 810013062 111020968 111024569 810019007 810016321 111019441 111009829 810019550 810011314 810008632 810022091 810027144 111021438 111023543 111023723 111023725 810011347 810018958 111022778 810022359 810021356 810015787 111011957 111011365 111011377 810019332 111014945 810019531 111000268 111024367 111003325 810016307 111000159 111010469 810015779 111003548 810016384 810022140 111013983 111003326 111008599 810026973 810011492 810011506 810027535 111005533 111011212 810011317 810003947 111024205 810021505 810011377 810016306 111014012 810027029 810016539 111000674 111000608 111001084 810016650 111001585 111001034 111011432 111011612 810016543 810011394 810003434 111018288 111018261 111012467 810022371 810019324 111014938 111001997 810027128 111011905 810027016 810027000 111011974 810026968 111009789 111013980 111021842 111022088 111010776 111014009 111021982 111021850 810011368 111024192 810011524 111021537 111024181 810027025 810027163 111016837 111024082 111022073 111022977 810016148 810016305 810004758 111022762 810021537 810007405 111022589 810011505 111011360 111024193 810016356 111018785 810019410 810016534 810016547 111003083 810013336 810013094 810011548 810007432 810008525 111018648 111018276 111022080 810004816 111006552 111018278 810015821 810021541 111021318 810011322 810005324 111020982 111010785 111009753 111000214 111000657 111011453 810015961 810008615 111009749 810015958 810003344 111015637 111024213 810007430 111002399 810026950 111018676 111002401 111001026 810016648 810011496 111022963 111008597 810011334 810011531 111011245 810019421 810011468 111009767 111003968 111006551 111009248 810027526 111008605 111008579 111024194 810021585 111006546 810019323 111016728 111022979 111000213 810019920 810016326 810016373 111022590 810013183 810004568 810015827 810011381 810022065 810015802 810026988 810016330 810027030 810027043 810004847 810016357 810015786 111022596 810015832 111019435 111016733 111021795 111004270 810011365 111019408 111003677 111011221 111010439 111011912 111014932 810018997 810011508 810013069 810013200 810019425 810022383 111016738 111013998 111023545 111014003 111011633 111003335 111003042 111011973 111009744 111003328 111003348 111004643 111004281 810016355 810007417 810021620 810016150 810016657 810015943 111021714 810007441 111003554 810008609 810027160 111011190 111018117 111003502 810026937 810013076 111003287 111009723 111009345 111018639 111009772 111011206 111021711 111012266 810021503 111011207 111020970 111015650 810021605 810019062 810019308 111008590 111009731 111003512 810013047 810021722 111008609 111002397 810018952 111003052 111009270 111024382 810016378 810021733 810021717 810018963 810005282 810016555 111021821 810008490 111021984 810003459 111013969 810019011 810013227 111003674 810013231 111011900 810019048 111018652 111012261 810003734 111003278 111012475 111021016 810011320 810021729 810011306 810021597 111003682 810011513 810013078 111008598 111018660 810019258 111011954 810013239 810019435 111021803 111004713 810019319 111023736 810026952 810026987 111011990 810019068 111002741 111005530 111011246 810013348 111011626 111004522 111004514 111018659 810007426 111004716 810018988 810008599 111003136 810022071 810019033 810013240 810003428 810008518 810019330 111011255 810016165 111014928 111011442 111003354 810016438 111009814 111000261 810016157 111016830 111003290 111012305 810007423 111003488 111004508 111021825 111003363 111011934 810008638 810016458 810016457 111014930 111003347 111021462 111006548 111008604 810013091 111024390 111001880 111024176 111009819 810021354 810021710 810021697 810019291 810018977 810016521 810016638 810015788 810013224 810027013 111003072 810016098 111009725 111019447 810011499 111012281 111011236 111016726 111019462 111023519 810011441 111021697 111009732 810015814 810013198 111020956 111024547 810011301 111009768 111021029 111002404 111011200 111022777 111006774 111003689 111021987 111021431 111021538 111020959 810013287 810021612 111013972 810026953 111014005 111017224 111018806 810026928 810011373 111003651 810005298 810021518 810015789 810019528 810005248 810013205 810013447 810013188 111021849 111000247 111006554 111017243 810022073 111016725 111014010 111003652 111022582 111022772 111022581 810011356 810007458 810021373 810026962 810011378 111010790 111002392 810016116 111024393 111021979 111021991 111022595 111024376 810026992 810003674 111021696 810016550 111003359 111010443 111002417 111021720 111023542 810011522 111009696 111009697 810016568 111009796 111009246 111009807 810027023 810011448 810021589 111010464 810016337 810021538 111018800 810027155 111021003 810003427 111020958 111006787 111010772 810019438 111022945 810005307 111022959 810008556 810013430 111001024 111001580 111012464 810022092 810021699 810004815 111023551 111011444 111018136 111001014 111011224 111003345 111001080 111002453 111011985 111001577 111003289 111003954 810007433 111011217 111012302 810005245 111009260 810027545 111003285 810016579 810022136 111009779 810027142 111009780 810022118 111009771 810003342 810005290 810022127 111011627 810019280 111008699 111018796 111008705 111008611 111003566 810005237...

Label field

Details supplied by the agency

Lot, code or applicability

Gallant: Model Number: VR ICD REF CDVRA500Q UDI-DI Code: 05415067031990 Serial Numbers: 111033498 810000696 810002524 111031208 111025117 111030959 111006327 111028481 111014296 111033775 810021414 810001946 810001996 810002011 810001942 810007459 111036536 810019608 810019393 810019581 111042257 810026722 810028531 810028585 810027003 111011936 810021423 111025530 111015227 111036960 810026790 111036957 111036933 111036964 111007506 810021413 810021445 810021449 111033604 111000553 111000558 111000567 111000472 111000706 111000667 111006793 111000664 111000678 111018664 111018644 111018802 111012460 111006783 111006791 111006789 111000786 111000582 111000550 111000721 111001035 111001025 111014950 111021456 111021461 111021703 111021722 111021450 111036417 111012272 111011597 810001013 810001011 810006759 810001046 810001021 810019014 111024417 810002439 111024415 810006774 111024454 810022318 111036914 810013066 810015963 111002002 810021662 810013192 810011364 111003380 810011481 111020960 111011436 111020992 810015820 810015794 111009835 111004271 111003046 111024175 111022969 111009840 810019313 810018954 111021002 111009844 810008620 111010818 810018999 111021710 810016110 810019437 810008498 111024550 810008497 810019426 810011359 810019424 810011511 810011353 810011328 111011181 111011372 111021007 111021712 111024183 810013436 810019054 810019546 810022117 810027515 810013071 810007469 111020996 111009733 111003861 111009782 810011335 810016103 111021851 810004570 111008584 111009245 111003267 810008499 111021988 111012318 111003040 111010800 111003332 111022768 810016526 810027041 111009747 810013248 111011899 111010457 810021351 810021705 810015780 111018656 111010771 111021437 810005318 111010761 111022974 111021994 810007454 810008483 810011285 810011458 810005317 111008582 111003173 111008588 111003555 111018654 810027111 810019552 810016459 111009820 810008557 810026959 111002712 111021707 111006776 111006779 111010814 111017230 810021576 810016112 111003506 810027040 810027014 810003350 111009781 111018131 810021674 111011908 810008527 810019917 111008583 810008575 111004282 810016339 810027099 810015815 810016102 111002437 111011229 111018270 810021707 810013068 810013216 810015840 810018976 810021355 810011459 111003500 111019459 810003430 111009834 111010787 111000447 111004193 111009841 111013996 111011233 111011254 111021837 111019423 810011451 111018786 810016113 810016649 810013446 810013250 810013442 810027039 810026943 810026944 810027020 810027165 111009759 111006801 111021440 111010437 111019431 810011457 810016665 810016449 810019012 810021618 810008573 810021560 810011535 111009788 810013454 810008650 810015824 111006778 810005319 111024379 810013349 810004013 111009809 810008519 111024368 810003553 111024378 111006784 810016140 810008486 111006797 810013266 111018109 111018795 111022789 111011910 810021606 810007463 810007421 810003677 111011216 810027514 111018640 810019556 810008612 111018784 111024402 810003437 810011343 810008526 111004721 111021995 810027548 810018995 810016138 810019427 810005706 111022585 810011387 111018291 111011963 111009708 111010450 111017239 111022090 111024180 111011906 111021723 111021436 810022090 810015784 111009794 111021433 810003343 810013241 111010980 810027103 111011915 111002410 810027161 111001995 111009741 111006541 111002011 810016121 111004259 111003960 810021559 111024204 810013232 111016740 810027168 810015796 111001027 111012290 111002434 111010962 111001969 810015822 111016745 111024202 111012258 111010952 111024184 111013804 111022788 111010465 810019529 810011303 111013808 810011549 810011538 111021812 810005366 810007473 111023732 111014948 111013807 111001583 111023720 111022587 111011938 810026979 111012462 111012307 111003869 111024186 810016277 111004242 810005286 111022781 111021845 810004846 810015783 111019446 810022064 111010799 111011214 810022363 111009828 810008597 111021790 111003559 810016560 111011185 810013225 111013993 810013206 111011922 111003276 810018982 111003858 810013077 810011449 810011550 810016303 111011237 111019415 111003865 111006785 111003863 111004182 111021466 810004849 111012256 111006775 810022137 810019296 810019297 111018120 111018679 810003615 810008594 111003065 111003037 810022370 810022129 810019042 111004513 111003074 111022971 111003957 810005356 111004518 111023531 111003371 111014919 111009837 111003539 111002743 810019250 810011523 810019254 111021846 111022077 810021666 810022122 810021671 810019272 810019301 810019290 810019278 810019065 810019325 810019408 810019310 810019293 810019009 111009737 111011215 111009766 111009777 111003521 111010981 111011968 111009261 111003686 111017247 111017245 111003567 111003505 810015772 810015773 111004497 111017234 810013185 810019050 810011339 810022145 810022376 810022079 810022078 810021530 810021687 810021563 810018946 810019017 810016151 810027033 810013203 810011349 810011369 810008563 810004696 111021010 111024381 111024199 111020974 111019443 111022093 111022955 810016344 810016656 810016653 810016532 111011363 111008706 111003365 111003283 111000464 111003963 810019260 111004523 111004267 810013197 810022087 810011461 810022126 810016310 111003691 111003350 810007437 111021445 111003695 810013245 111000473 111011969 111012312 810013196 810011305 810015962 111017246 810016105 810011298 810027536 810011487 111012295 810027150 111012279 810016644 111024214 111018263 111018111 111000666 111000560 111011981 111000658 810027036 111020994 111009262 810005321 111011380 111003688 111003510 810021545 810005705 810005253 810005296 111022085 111024394 810003454 111018643 810018983 111011603 111011367 111000462 111021429 810013477 810022094 810019059 111010780 810013451 111021843 810013458 810019282 111000541 111021815 810011470 810008640 111000757 810011337 810016363 810021520 111000792 111003514 111000441 111021811 810011358 810027159 810016146 810019063 810019539 810022082 111021717 810011295 111024398 111000440 810015797 810015800 810013448 810016145 810016322 810019268 810021602 810021664 111001076 111004164 810007406 111011247 111011227 111011226 111010454 111010436 111010773 111010448 810022110 111024549 111024380 111021824 810022096 810008474 810007403 810007413 810007434 111021000 810026542 810016270 810018953 810026999 810007427 810008536 810008637 810019443 810021702 111008602 810005709 111021724 810005279 111012296 111000803 111003508 111004172 111000996 111020952 111014955 810018966 111001082 810016155 810018955 810018996 111003680 810019057 810016524 810016334 810019019 810018980 111009773 810021369 810019524 810019525 810021376 111022089 111011375 111024197 810019441 810019442 810007414 810008607 810021578 810008595 810022141 810008591 810008603 810021616 810007416 111000150 810019010 810011503 810022107 810007410 810016323 810013062 111020968 111024569 810019007 810016321 111019441 111009829 810019550 810011314 810008632 810022091 810027144 111021438 111023543 111023723 111023725 810011347 810018958 111022778 810022359 810021356 810015787 111011957 111011365 111011377 810019332 111014945 810019531 111000268 111024367 111003325 810016307 111000159 111010469 810015779 111003548 810016384 810022140 111013983 111003326 111008599 810026973 810011492 810011506 810027535 111005533 111011212 810011317 810003947 111024205 810021505 810011377 810016306 111014012 810027029 810016539 111000674 111000608 111001084 810016650 111001585 111001034 111011432 111011612 810016543 810011394 810003434 111018288 111018261 111012467 810022371 810019324 111014938 111001997 810027128 111011905 810027016 810027000 111011974 810026968 111009789 111013980 111021842 111022088 111010776 111014009 111021982 111021850 810011368 111024192 810011524 111021537 111024181 810027025 810027163 111016837 111024082 111022073 111022977 810016148 810016305 810004758 111022762 810021537 810007405 111022589 810011505 111011360 111024193 810016356 111018785 810019410 810016534 810016547 111003083 810013336 810013094 810011548 810007432 810008525 111018648 111018276 111022080 810004816 111006552 111018278 810015821 810021541 111021318 810011322 810005324 111020982 111010785 111009753 111000214 111000657 111011453 810015961 810008615 111009749 810015958 810003344 111015637 111024213 810007430 111002399 810026950 111018676 111002401 111001026 810016648 810011496 111022963 111008597 810011334 810011531 111011245 810019421 810011468 111009767 111003968 111006551 111009248 810027526 111008605 111008579 111024194 810021585 111006546 810019323 111016728 111022979 111000213 810019920 810016326 810016373 111022590 810013183 810004568 810015827 810011381 810022065 810015802 810026988 810016330 810027030 810027043 810004847 810016357 810015786 111022596 810015832 111019435 111016733 111021795 111004270 810011365 111019408 111003677 111011221 111010439 111011912 111014932 810018997 810011508 810013069 810013200 810019425 810022383 111016738 111013998 111023545 111014003 111011633 111003335 111003042 111011973 111009744 111003328 111003348 111004643 111004281 810016355 810007417 810021620 810016150 810016657 810015943 111021714 810007441 111003554 810008609 810027160 111011190 111018117 111003502 810026937 810013076 111003287 111009723 111009345 111018639 111009772 111011206 111021711 111012266 810021503 111011207 111020970 111015650 810021605 810019062 810019308 111008590 111009731 111003512 810013047 810021722 111008609 111002397 810018952 111003052 111009270 111024382 810016378 810021733 810021717 810018963 810005282 810016555 111021821 810008490 111021984 810003459 111013969 810019011 810013227 111003674 810013231 111011900 810019048 111018652 111012261 810003734 111003278 111012475 111021016 810011320 810021729 810011306 810021597 111003682 810011513 810013078 111008598 111018660 810019258 111011954 810013239 810019435 111021803 111004713 810019319 111023736 810026952 810026987 111011990 810019068 111002741 111005530 111011246 810013348 111011626 111004522 111004514 111018659 810007426 111004716 810018988 810008599 111003136 810022071 810019033 810013240 810003428 810008518 810019330 111011255 810016165 111014928 111011442 111003354 810016438 111009814 111000261 810016157 111016830 111003290 111012305 810007423 111003488 111004508 111021825 111003363 111011934 810008638 810016458 810016457 111014930 111003347 111021462 111006548 111008604 810013091 111024390 111001880 111024176 111009819 810021354 810021710 810021697 810019291 810018977 810016521 810016638 810015788 810013224 810027013 111003072 810016098 111009725 111019447 810011499 111012281 111011236 111016726 111019462 111023519 810011441 111021697 111009732 810015814 810013198 111020956 111024547 810011301 111009768 111021029 111002404 111011200 111022777 111006774 111003689 111021987 111021431 111021538 111020959 810013287 810021612 111013972 810026953 111014005 111017224 111018806 810026928 810011373 111003651 810005298 810021518 810015789 810019528 810005248 810013205 810013447 810013188 111021849 111000247 111006554 111017243 810022073 111016725 111014010 111003652 111022582 111022772 111022581 810011356 810007458 810021373 810026962 810011378 111010790 111002392 810016116 111024393 111021979 111021991 111022595 111024376 810026992 810003674 111021696 810016550 111003359 111010443 111002417 111021720 111023542 810011522 111009696 111009697 810016568 111009796 111009246 111009807 810027023 810011448 810021589 111010464 810016337 810021538 111018800 810027155 111021003 810003427 111020958 111006787 111010772 810019438 111022945 810005307 111022959 810008556 810013430 111001024 111001580 111012464 810022092 810021699 810004815 111023551 111011444 111018136 111001014 111011224 111003345 111001080 111002453 111011985 111001577 111003289 111003954 810007433 111011217 111012302 810005245 111009260 810027545 111003285 810016579 810022136 111009779 810027142 111009780 810022118 111009771 810003342 810005290 810022127 111011627 810019280 111008699 111018796 111008705 111008611 111003566 810005237...

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

U.S.: Nation-wide O.U.S.: Australia, Austria, Bahrain, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Nepal, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom. Latin America - Pending

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

Dates in the source

Report date: Sep 27, 2023
Recall initiation date: Aug 16, 2023
Center classification date: Sep 19, 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