Recall archive / FDA device enforcement

Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance ... — FDA record Z-1027-2023

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 Dec 12, 2022. 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: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
Reason: An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Classification: Class II
Recalling firm: Medtronic Perfusion Systems
Quantity: 63,278 units
Agency-reported status: Ongoing
Source record identifier: Z-1027-2023

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	Oxygenator Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number, Tubing Pack Model Number (Lot Numbers): 00643169231948, M390082B (223422891, 223952683, 225651632); 00643169345379, M961233A (223537804); 00643169422025, M445428F (223378929, 223672423, 223909336, 224399508, 224695321, 225303449, 225434680); 00643169439269, M274805B (223714089, 224907239); 00643169449442, BB6U40R11 (223728548, 224155209, 224539886, 224794461); 00643169469495, BB4Q12R15 (223612682, 224026310); 00643169572263, HY8L55R5 (225033983, 225033984, 225045278, 225126456); 00643169583542, M330119D (223547370, 224206448, 225484644); 00643169621473, BB8U95R1 (223488691, 223764562, 225251346); 00643169622715, BB8B70R7 (224281969, 224664696); 00643169632097, M721107D (223538837, 223588897, 224380964, 224567880, 225089620, 225528159); 00643169639027, BB3X42R13 (223558525, 223896827, 224155078, 224664710, 224815782); 00643169645424, BB8M16R3 (224155078); 00643169674486, M722001A (223614712, 224077488, 225161996); 00643169692893, BB8P01R7 (223066047, 223644491, 223983902, 224573049, 225047877); 00643169711945, BB8T77R2 (223283021, 224497848); 00643169717336, BB8Q09R2 (223054336, 223206892, 223409300, 223573934, 223804327, 223896843, 224066169, 224327204, 224664704, 224664705, 224985026, 225170609); 00643169750883, BB8J66R17 (222974930, 222974932, 223206895, 223274762, 224066185, 224282025, 224454020, 224539805, 224752687, 224838236, 224838238); 00643169793699, BB8C33R6 (223234986, 224281982); 00643169793927, BB8M48R5 (223685618, 223833474, 224963605); 00643169840058, M342615P (223630909, 224033583, 224311665, 224567877, 225048104, 225303159, 225484317); 00643169860643, M482903D (223672424, 223969961, 224312691, 224735824, 225207742, 225561384); 00643169865365, BB9D32R2 (223033102, 223127174, 223488375, 223851344, 224233682, 224281957, 224573053, 224794262, 224794263); 00643169872127, BB9L72R1 (223145738, 223631537, 223896364, 224664748, 224923414, 225126448); 00643169876743, BB9B43R3 (223573837, 224794493); 00643169876903, BB8U52R8 (223728547, 224281942, 224473476); 00643169955790, BB3M00R30 (223896474, 224497817, 225047868); 00643169957008, M483002C (223508310, 223815840, 224008812, 224075857, 224992815, 225161643, 225560932); 00643169998643, BB9J85R3 (222974878, 223728616, 224442258, 224963603); 00763000006884, M721902F (223665117, 224069967); 00763000008215, BB8E47R17 (223896458, 224582573); 00763000014001, M059709E (223808314); 00763000014971, HY9E07R9 (223006393, 223764172, 224497852, 225047918); 00763000016944, M447026J (223311071, 224033576, 224525725, 225089619); 00763000021887, M450202J (223378878, 223482251, 223569832, 223695950, 224399265, 224695323, 224948490, 225208459); 00763000024406, BB9N31R3 (223323272, 223603527, 224414960); 00763000025878, BB4B15R14 (223283065, 224066162, 224497806, 225219652); 00763000026240, BB10D95R (224923422); 00763000062613, M233101D (223926251); 00763000062637, M233105F (223926253); 00763000064242, M447708H (223240765, 223909585, 224252242, 224567886, 224736688, 225209646, 225436092, 225651518); 00763000077747, HY0W84R31 (225059180); 00763000099831, BB10B90R6 (223283006, 224277441, 224752773); 00763000112035, M412501B (224115258, 224465727, 224736967, 225303530); 00763000118914, BB8P23R4 (223112645, 224154996, 225104523, 225398699); 00763000126315, BB10H89R4 (223498029, 223896315); 00763000133030, HY9S48R4 (223060795); 00763000135348, BB7J04R11 (223112635, 223603534, 224327223, 224539803, 224811484); 00763000135355, BB8H01R4 (224155218, 224476527, 224923391); 00763000139513, BB8N34R6 (222974686, 223409294, 224019319, 224516511); 00763000139742, M720109G (223378927, 223532940, 224122998, 224652776, 224907237, 225254267); 00763000141363, BB9R53R7 (223235051, 224370597); 00763000155353, BB8C53R12 (222982219, 223558532, 223728602); 00763000159504, M273508D (223994900, 225049328); 00763000162245, M371203C (223540014, 223953001, 224865428, 225346409); 00763000175726, HY10G12R7 (223558545); 00763000178048, BB7Y33R8 (223014654, 223196558, 225047919); 00763000186180, M410209L (223422890, 223969951, 224337397, 224993580); 00763000188276, BB8G43R7 (223342946, 223922491, 224497816, 224923386); 00763000201159, BB8P06R10 (223282994, 223558454, 224281953, 224582631); 00763000201456, BB10S84R (223014671, 223165007, 223206893, 223896868, 224539690); 00763000203405, M391414L (223439639, 224008699, 225065951, 225254280); 00763000211271, HY9R12R13 (224112059); 00763000214531, M331107A (225049339); 00763000224349, BB0E27R32 (223165010); 00763000231538, BB2493R44 (222918292, 223169854, 223558505); 00763000233259, HY5V41R21 (225008158); 00763000234911, BB10P38R2 (222980256, 223728607, 224281988); 00763000236588, HY7E57R17 (224923409); 00763000245351, M495523C (224993583); 00763000246914, M483804B (223508320, 224123002, 225228308); 00763000252663, M721333F (223385805, 223816583, 225331628); 00763000255220, BB8Q56R7 (223044144, 223498060, 223939254, 223967258, 224327237, 224582569, 225086642); 00763000256739, BB8D44R6 (223014665, 223366534, 223896431, 224282016, 224664764, 225270451); 00763000258535, BB10X94R1 (223014672, 223939240, 225170565); 00763000260217, BB8L80R5 (223804388, 224282106, 224752767, 224827938); 00763000262372, BB8X02R9 (223728556, 224282007, 225047878); 00763000263799, BB10S31R3 (223748240, 224196599); 00763000273026, BB8E21R10 223196716); 00763000274610, BB8M09R1 (223645439, 223764064); 00763000275259, BB6M22R15 (224752717); 00763000275341, BB4Z62R19 (223113114, 223728590, 224155206, 224196598, 224370575, 224370576, 224838243, 225008581, 225126482); 00763000276010, BB10V32R (223728486, 223833388, 224758658, 224826799); 00763000280277, M344803C (223648108); 00763000286897, BB10Y67R3 (223234951, 223454165, 224155184, 224539899); 00763000287948, HY9G02R4 (224963556); 00763000288266, HY7W91R22 (225047922); 00763000291839, M337709C (223753451, 224252233, 224948527, 225484643); 00763000293796, BB7H73R17 (223066046, 223334261, 223983917); 00763000299064, BB10S01R2 (225008518); 00763000299859, HY10W55R4 (223060796, 223742623, 223896428); 00763000300692, BB8B96R14 (223095081, 223308375, 223851415, 224327302, 224727367, 224727381); 00763000300937, P490302G (223952674); 00763000316976, HY7V82R20 (225126488, 225126489, 225126490); 00763000319984, HY10S39R3 (223983866); 00763000324773, BB8C09R8 (223409262, 224539793); 00763000325190, M075502A (224419078); 00763000334079, BB10E61R4 (223196718, 223558523, 224281959, 224681554, 225047867); 00763000334710, M612704H (223589853, 224048919, 224399524, 224644262, 225528147); 00763000339319, BB10X57R2 (222974895, 223283046, 223685655, 224281979, 224623803, 225170602); 00763000339319, BB10X57R2 (224794435); 00763000339982, M490645H (223393275, 223713005, 223862637, 224033582, 224337395); 00763000341053, M343105N (223241295, 224188635, 225651514); 00763000343088, M390728D (223712998, 224206461, 225120479, 225303518); 00763000343101, M333715H (223508318); 00763000343125, M391714B (223245021, 223521591, 224096698); 00763000344467, HY2U43R17 (222918489, 223366491, 224019352, 224582540); 00763000345082, BB11D80R (223366501, 223922494, 224582570); 00763000345341, M341506M (223752205, 224493232, 224865426, 225303515); 00763000346478, BB10P64R2 (223054331, 223054338, 223939276, 224454048, 224879178); 00763000346508, BB10N96R9 (223039591, 223409295, 223851363, 224282011, 224664692); 00763000347468, M393929B (224008686); 00763000351632, M322226B (223311076, 223837958, 224652840); 00763000353988, BB8B99R6 (223014674, 223054435, 223283257, 223728610, 224066167, 224281974, 224454133, 224582611, 224784931, 224827935); 00763000361631, BB10V51R6 (223644493, 224026309, 224327297, 224582608, 225126484); 00763000362119, BB11A97R2 (223100965, 223232472, 223323298, 223366554, 223558497, 223558498, 223558499, 224112033, 224281950, 224370559, 224454051, 224454052, 224539876, 224794434, 224963551, 224963552, 225270478); 00763000365837, BB11C80R1 (223234952, 223728861, 224281954, 224827933, 224908927, 225398632); 00763000367671, HY10R64R10 (224794438); 00763000369798, BB10R29R9 (223283067, 223764143, 224155201, 224281965, 224438188, 224807342); 00763000371456, BB1A19R53 (223127717, 223558636, 223741575, 224005631, 224370568, 224370569, 224623765, 225086681); 00763000373955, BB8G55R15 (225170562); 00763000378493, BB11E97R1 (223939212); 00763000378707, BB8D19R9 (223851379, 224752796, 225443660); 00763000400071, BB5N63R5 (224111962, 224497871, 225126503, 225219702); 00763000400576, BB10Y59R9 (223644492, 224497855, 225408501); 00763000401979, M632007A (223552152, 223552153, 224033798); 00763000402501, M483507A (223422023, 223862847, 224224164, 224297726, 224907140, 225090699, 225346302, 225651635); 00763000404062, M075204A (223482693); 00763000404239, M494833G (223466603, 223612884, 223695960, 224865316, 225389397); 00763000408343, HY8T43R9 (222991247, 222991247, 223093372, 223093372, 223728599, 223728599, 223851364, 223896429, 223896429, 224019182, 224019182, 224019183, 224019183, 224019184, 224019184, 224370593, 224370593, 224370594, 224370594, 224497860, 224497860); 00763000408350, BB7V97R15 (223033103, 223196545, 223498044, 223603535, 223983880, 224232482, 224232482, 224281943, 224327276, 224370542, 224370543, 224497755, 224497756, 224497756, 224794357, 224794357, 224794358, 224794358, 225126493); 00763000408824, M964503C (223484468, 224711012); 00763000412128, M334211F (225651640); 00763000412838, BB10L76R4 (223323277, 224155000, 224794449); 00763000412883, BB8W14R8 (223093369, 223206888, 223488706, 223764171, 223931082, 224243204, 224529301, 224529301); 00763000415518, M442233G (223521613, 223882114, 224225700, 224610491); 00763000416355, BB10Q99R11 (223026452, 223206896, 223366549, 223685610, 223685611, 224112042, 224282010, 224454017, 224539762, 224565388, 224879086, 225086646, 225311198); 00763000416980, HY11G55R1 (223558536, 223983966, 224370546, 224370547, 224963529); 00763000417642, M720727L (223672425, 223881861, 224652780, 225161916); 00763000417666, M720413J (225049343); 00763000418649, BB8E17R7 (224019348, 224019348, 224170585, 224327212, 224539786, 224539786, 224879115, 224879115); 00763000418748, M333816C (224206455); 00763000425760, BB10R49R6 (223054433, 223103737, 223764138, 224170582, 224281990, 224539789, 224794453, 225219686); 00763000426002, HY11E26R3 (222724087); 00763000426354, BB5Z97R18 (222998309, 223172628, 223804414, 224281949, 224370558, 224923413); 00763000428488, HY10H88R12 (223343008, 223764185, 224327202, 224794432); 00763000428716, BB3V10R34 (224282013); 00763000429058, M445885K (223352900, 223466329, 223815842, 224138282, 224652778, 225041058, 225436095); 00763000431570, HY10L69R7 (223173597, 223685788, 223685788); 00763000431822, M450311U (223303584, 223837444, 223908982); 00763000431839, M342507G (224865311, 225651642); 00763000431860, M422114D (224652877, 225273957); 00763000431877, M340615R (223393278, 223714094, 224096966, 224337418, 225090362, 225484631); 00763000432638, BB8S31R13 (223983970, 224923408); 00763000432669, HY11L82R1 (223366499, 223896483); 00763000432959, M330416E (223881865, 224048911, 224397994, 224865226, 225254273, 225447057); 00763000436612, M332410K (223864228); 00763000439828, BB5U30R11 (223366471, 224539686); 00763000439835, BB8U85R3 (223112591, 224539693); 00763000442613, P393001E (223260994, 223775521, 224206457, 224736692, 225346296); 00763000442750, M346203E (223508309, 223881863, 224047764, 225040700, 225434676, 225651643); 00763000445904, BB10J28R7 (223558533, 224327244, 225086634); 00763000455149, M399004Q (223714088, 224695402, 225208455); 00763000458072, HY10N63R6 (222755419, 224388050); 00763000458164, BB11A61R3 (223558486, 224112029, 224497813, 225008562); 00763000467074, BB8B22R14 (223002552); 00763000467487, M482406A (223532934, 223837990, 224252237, 225161991, 225651629); 00763000474058, BB9G98R8 (224196587, 224578585, 225170623); 00763000479428, M332831G (223303585, 223753452, 223993384, 224225698, 224865200); 00763000479626, BB11G35R3 (224826824); 00763000486723, M33621...

Label field

Details supplied by the agency

Lot, code or applicability

Oxygenator Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number, Tubing Pack Model Number (Lot Numbers): 00643169231948, M390082B (223422891, 223952683, 225651632); 00643169345379, M961233A (223537804); 00643169422025, M445428F (223378929, 223672423, 223909336, 224399508, 224695321, 225303449, 225434680); 00643169439269, M274805B (223714089, 224907239); 00643169449442, BB6U40R11 (223728548, 224155209, 224539886, 224794461); 00643169469495, BB4Q12R15 (223612682, 224026310); 00643169572263, HY8L55R5 (225033983, 225033984, 225045278, 225126456); 00643169583542, M330119D (223547370, 224206448, 225484644); 00643169621473, BB8U95R1 (223488691, 223764562, 225251346); 00643169622715, BB8B70R7 (224281969, 224664696); 00643169632097, M721107D (223538837, 223588897, 224380964, 224567880, 225089620, 225528159); 00643169639027, BB3X42R13 (223558525, 223896827, 224155078, 224664710, 224815782); 00643169645424, BB8M16R3 (224155078); 00643169674486, M722001A (223614712, 224077488, 225161996); 00643169692893, BB8P01R7 (223066047, 223644491, 223983902, 224573049, 225047877); 00643169711945, BB8T77R2 (223283021, 224497848); 00643169717336, BB8Q09R2 (223054336, 223206892, 223409300, 223573934, 223804327, 223896843, 224066169, 224327204, 224664704, 224664705, 224985026, 225170609); 00643169750883, BB8J66R17 (222974930, 222974932, 223206895, 223274762, 224066185, 224282025, 224454020, 224539805, 224752687, 224838236, 224838238); 00643169793699, BB8C33R6 (223234986, 224281982); 00643169793927, BB8M48R5 (223685618, 223833474, 224963605); 00643169840058, M342615P (223630909, 224033583, 224311665, 224567877, 225048104, 225303159, 225484317); 00643169860643, M482903D (223672424, 223969961, 224312691, 224735824, 225207742, 225561384); 00643169865365, BB9D32R2 (223033102, 223127174, 223488375, 223851344, 224233682, 224281957, 224573053, 224794262, 224794263); 00643169872127, BB9L72R1 (223145738, 223631537, 223896364, 224664748, 224923414, 225126448); 00643169876743, BB9B43R3 (223573837, 224794493); 00643169876903, BB8U52R8 (223728547, 224281942, 224473476); 00643169955790, BB3M00R30 (223896474, 224497817, 225047868); 00643169957008, M483002C (223508310, 223815840, 224008812, 224075857, 224992815, 225161643, 225560932); 00643169998643, BB9J85R3 (222974878, 223728616, 224442258, 224963603); 00763000006884, M721902F (223665117, 224069967); 00763000008215, BB8E47R17 (223896458, 224582573); 00763000014001, M059709E (223808314); 00763000014971, HY9E07R9 (223006393, 223764172, 224497852, 225047918); 00763000016944, M447026J (223311071, 224033576, 224525725, 225089619); 00763000021887, M450202J (223378878, 223482251, 223569832, 223695950, 224399265, 224695323, 224948490, 225208459); 00763000024406, BB9N31R3 (223323272, 223603527, 224414960); 00763000025878, BB4B15R14 (223283065, 224066162, 224497806, 225219652); 00763000026240, BB10D95R (224923422); 00763000062613, M233101D (223926251); 00763000062637, M233105F (223926253); 00763000064242, M447708H (223240765, 223909585, 224252242, 224567886, 224736688, 225209646, 225436092, 225651518); 00763000077747, HY0W84R31 (225059180); 00763000099831, BB10B90R6 (223283006, 224277441, 224752773); 00763000112035, M412501B (224115258, 224465727, 224736967, 225303530); 00763000118914, BB8P23R4 (223112645, 224154996, 225104523, 225398699); 00763000126315, BB10H89R4 (223498029, 223896315); 00763000133030, HY9S48R4 (223060795); 00763000135348, BB7J04R11 (223112635, 223603534, 224327223, 224539803, 224811484); 00763000135355, BB8H01R4 (224155218, 224476527, 224923391); 00763000139513, BB8N34R6 (222974686, 223409294, 224019319, 224516511); 00763000139742, M720109G (223378927, 223532940, 224122998, 224652776, 224907237, 225254267); 00763000141363, BB9R53R7 (223235051, 224370597); 00763000155353, BB8C53R12 (222982219, 223558532, 223728602); 00763000159504, M273508D (223994900, 225049328); 00763000162245, M371203C (223540014, 223953001, 224865428, 225346409); 00763000175726, HY10G12R7 (223558545); 00763000178048, BB7Y33R8 (223014654, 223196558, 225047919); 00763000186180, M410209L (223422890, 223969951, 224337397, 224993580); 00763000188276, BB8G43R7 (223342946, 223922491, 224497816, 224923386); 00763000201159, BB8P06R10 (223282994, 223558454, 224281953, 224582631); 00763000201456, BB10S84R (223014671, 223165007, 223206893, 223896868, 224539690); 00763000203405, M391414L (223439639, 224008699, 225065951, 225254280); 00763000211271, HY9R12R13 (224112059); 00763000214531, M331107A (225049339); 00763000224349, BB0E27R32 (223165010); 00763000231538, BB2493R44 (222918292, 223169854, 223558505); 00763000233259, HY5V41R21 (225008158); 00763000234911, BB10P38R2 (222980256, 223728607, 224281988); 00763000236588, HY7E57R17 (224923409); 00763000245351, M495523C (224993583); 00763000246914, M483804B (223508320, 224123002, 225228308); 00763000252663, M721333F (223385805, 223816583, 225331628); 00763000255220, BB8Q56R7 (223044144, 223498060, 223939254, 223967258, 224327237, 224582569, 225086642); 00763000256739, BB8D44R6 (223014665, 223366534, 223896431, 224282016, 224664764, 225270451); 00763000258535, BB10X94R1 (223014672, 223939240, 225170565); 00763000260217, BB8L80R5 (223804388, 224282106, 224752767, 224827938); 00763000262372, BB8X02R9 (223728556, 224282007, 225047878); 00763000263799, BB10S31R3 (223748240, 224196599); 00763000273026, BB8E21R10 223196716); 00763000274610, BB8M09R1 (223645439, 223764064); 00763000275259, BB6M22R15 (224752717); 00763000275341, BB4Z62R19 (223113114, 223728590, 224155206, 224196598, 224370575, 224370576, 224838243, 225008581, 225126482); 00763000276010, BB10V32R (223728486, 223833388, 224758658, 224826799); 00763000280277, M344803C (223648108); 00763000286897, BB10Y67R3 (223234951, 223454165, 224155184, 224539899); 00763000287948, HY9G02R4 (224963556); 00763000288266, HY7W91R22 (225047922); 00763000291839, M337709C (223753451, 224252233, 224948527, 225484643); 00763000293796, BB7H73R17 (223066046, 223334261, 223983917); 00763000299064, BB10S01R2 (225008518); 00763000299859, HY10W55R4 (223060796, 223742623, 223896428); 00763000300692, BB8B96R14 (223095081, 223308375, 223851415, 224327302, 224727367, 224727381); 00763000300937, P490302G (223952674); 00763000316976, HY7V82R20 (225126488, 225126489, 225126490); 00763000319984, HY10S39R3 (223983866); 00763000324773, BB8C09R8 (223409262, 224539793); 00763000325190, M075502A (224419078); 00763000334079, BB10E61R4 (223196718, 223558523, 224281959, 224681554, 225047867); 00763000334710, M612704H (223589853, 224048919, 224399524, 224644262, 225528147); 00763000339319, BB10X57R2 (222974895, 223283046, 223685655, 224281979, 224623803, 225170602); 00763000339319, BB10X57R2 (224794435); 00763000339982, M490645H (223393275, 223713005, 223862637, 224033582, 224337395); 00763000341053, M343105N (223241295, 224188635, 225651514); 00763000343088, M390728D (223712998, 224206461, 225120479, 225303518); 00763000343101, M333715H (223508318); 00763000343125, M391714B (223245021, 223521591, 224096698); 00763000344467, HY2U43R17 (222918489, 223366491, 224019352, 224582540); 00763000345082, BB11D80R (223366501, 223922494, 224582570); 00763000345341, M341506M (223752205, 224493232, 224865426, 225303515); 00763000346478, BB10P64R2 (223054331, 223054338, 223939276, 224454048, 224879178); 00763000346508, BB10N96R9 (223039591, 223409295, 223851363, 224282011, 224664692); 00763000347468, M393929B (224008686); 00763000351632, M322226B (223311076, 223837958, 224652840); 00763000353988, BB8B99R6 (223014674, 223054435, 223283257, 223728610, 224066167, 224281974, 224454133, 224582611, 224784931, 224827935); 00763000361631, BB10V51R6 (223644493, 224026309, 224327297, 224582608, 225126484); 00763000362119, BB11A97R2 (223100965, 223232472, 223323298, 223366554, 223558497, 223558498, 223558499, 224112033, 224281950, 224370559, 224454051, 224454052, 224539876, 224794434, 224963551, 224963552, 225270478); 00763000365837, BB11C80R1 (223234952, 223728861, 224281954, 224827933, 224908927, 225398632); 00763000367671, HY10R64R10 (224794438); 00763000369798, BB10R29R9 (223283067, 223764143, 224155201, 224281965, 224438188, 224807342); 00763000371456, BB1A19R53 (223127717, 223558636, 223741575, 224005631, 224370568, 224370569, 224623765, 225086681); 00763000373955, BB8G55R15 (225170562); 00763000378493, BB11E97R1 (223939212); 00763000378707, BB8D19R9 (223851379, 224752796, 225443660); 00763000400071, BB5N63R5 (224111962, 224497871, 225126503, 225219702); 00763000400576, BB10Y59R9 (223644492, 224497855, 225408501); 00763000401979, M632007A (223552152, 223552153, 224033798); 00763000402501, M483507A (223422023, 223862847, 224224164, 224297726, 224907140, 225090699, 225346302, 225651635); 00763000404062, M075204A (223482693); 00763000404239, M494833G (223466603, 223612884, 223695960, 224865316, 225389397); 00763000408343, HY8T43R9 (222991247, 222991247, 223093372, 223093372, 223728599, 223728599, 223851364, 223896429, 223896429, 224019182, 224019182, 224019183, 224019183, 224019184, 224019184, 224370593, 224370593, 224370594, 224370594, 224497860, 224497860); 00763000408350, BB7V97R15 (223033103, 223196545, 223498044, 223603535, 223983880, 224232482, 224232482, 224281943, 224327276, 224370542, 224370543, 224497755, 224497756, 224497756, 224794357, 224794357, 224794358, 224794358, 225126493); 00763000408824, M964503C (223484468, 224711012); 00763000412128, M334211F (225651640); 00763000412838, BB10L76R4 (223323277, 224155000, 224794449); 00763000412883, BB8W14R8 (223093369, 223206888, 223488706, 223764171, 223931082, 224243204, 224529301, 224529301); 00763000415518, M442233G (223521613, 223882114, 224225700, 224610491); 00763000416355, BB10Q99R11 (223026452, 223206896, 223366549, 223685610, 223685611, 224112042, 224282010, 224454017, 224539762, 224565388, 224879086, 225086646, 225311198); 00763000416980, HY11G55R1 (223558536, 223983966, 224370546, 224370547, 224963529); 00763000417642, M720727L (223672425, 223881861, 224652780, 225161916); 00763000417666, M720413J (225049343); 00763000418649, BB8E17R7 (224019348, 224019348, 224170585, 224327212, 224539786, 224539786, 224879115, 224879115); 00763000418748, M333816C (224206455); 00763000425760, BB10R49R6 (223054433, 223103737, 223764138, 224170582, 224281990, 224539789, 224794453, 225219686); 00763000426002, HY11E26R3 (222724087); 00763000426354, BB5Z97R18 (222998309, 223172628, 223804414, 224281949, 224370558, 224923413); 00763000428488, HY10H88R12 (223343008, 223764185, 224327202, 224794432); 00763000428716, BB3V10R34 (224282013); 00763000429058, M445885K (223352900, 223466329, 223815842, 224138282, 224652778, 225041058, 225436095); 00763000431570, HY10L69R7 (223173597, 223685788, 223685788); 00763000431822, M450311U (223303584, 223837444, 223908982); 00763000431839, M342507G (224865311, 225651642); 00763000431860, M422114D (224652877, 225273957); 00763000431877, M340615R (223393278, 223714094, 224096966, 224337418, 225090362, 225484631); 00763000432638, BB8S31R13 (223983970, 224923408); 00763000432669, HY11L82R1 (223366499, 223896483); 00763000432959, M330416E (223881865, 224048911, 224397994, 224865226, 225254273, 225447057); 00763000436612, M332410K (223864228); 00763000439828, BB5U30R11 (223366471, 224539686); 00763000439835, BB8U85R3 (223112591, 224539693); 00763000442613, P393001E (223260994, 223775521, 224206457, 224736692, 225346296); 00763000442750, M346203E (223508309, 223881863, 224047764, 225040700, 225434676, 225651643); 00763000445904, BB10J28R7 (223558533, 224327244, 225086634); 00763000455149, M399004Q (223714088, 224695402, 225208455); 00763000458072, HY10N63R6 (222755419, 224388050); 00763000458164, BB11A61R3 (223558486, 224112029, 224497813, 225008562); 00763000467074, BB8B22R14 (223002552); 00763000467487, M482406A (223532934, 223837990, 224252237, 225161991, 225651629); 00763000474058, BB9G98R8 (224196587, 224578585, 225170623); 00763000479428, M332831G (223303585, 223753452, 223993384, 224225698, 224865200); 00763000479626, BB11G35R3 (224826824); 00763000486723, M33621...

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 distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.

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: Feb 8, 2023
Recall initiation date: Dec 12, 2022
Center classification date: Jan 27, 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

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