Recall archive / FDA device enforcement

CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pr... — FDA record Z-1099-2026

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 10, 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: CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
Reason: Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
Classification: Class II
Recalling firm: Thoratec LLC
Quantity: 8399
Agency-reported status: Ongoing
Source record identifier: Z-1099-2026

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	UDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers. REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 10235019, 10235024, 10245539, 10245540, 10245541, 10245542, 10245543, 10256365, 10256366, 10289217, 10289218, 10291590, 10291591, 10301036, 10301037, 10301038, 10301039, 10301040, 10301041, 10301042, 10301043, 10301044, 10303473, 10303476, 10303477, 10303478, 10325561, 10341677, 10342238 10343635, 10343636, 10343637, 10343638, 10343639, 10343640, 10351700, 10351701, 10351702, 10351703, 10351704, 10351707, 10359524, 10359525, 10359526, 10359527, 10359528, 10359529, 10359530, 10359531, 10359532, 10371222, 10371223, 10371224, 10371225, 10371226, 10373595, 10373596, 10373597, 10373598, 10373599, 10391563, 10391564, 10391565, 10391566, 10398007, 10398008, 10398009, 10398010, 10398011, 10399853, 10399854, 10399855, 10399856, 10399857, 10399858, 10399859, 10399860, 10399861, 10399862, 10399866, 10399867, 10410026, 10410027, 10410028, 10410197, 10410198, 10410199, 10411641, 10411642, 10414322, 10414323, 10414324, 10414325, 10414326, 10416065, 10416066, 10416067, 10418871, 10419212, 10424524, 10428901, 10428902, 10428904, 10428905, 10428906, 10456505, 10456506, 10456507, 10456508, 10456509, 10457499, 10457500, 10457502, 10464083, 10464085, 10464086, 10464092, 10498116, 10498117, 10498118, 10517215, 10518978, 10518979, 10518980, 10518981, 10518982, 10528585, 10528587, 10528588, 10530704, 10530705, 10530706, 10535290, 10535294, 10535297, 10535299, 10535300, 10535302, 10541032, 10541033, 10541034, 10541035, 10543873, 10543874, 10550324, 10550325, 10550326, 10550328, 10550329, 10560628, 10560629, 10560630, 10567320, 10567321, 10567322, 10567323, 10571084, 10571085, 10571086, 10571087, 10571088, 10571090, 10588824, 10588825, 10588826, 10591390, 10591391, 10591392, 10591393, 10602157, 10602160, 10602161, 10602162, 10602163, 10602164, 10623578, 10623579, 10623581, 10623582, 10623583, 10632619, 10632625, 10632630, 10639955, 10639956, 10639957, 10639959, 10639960, 10646446, 10646447, 10646449, 10646450, 10646451, 10646452, 10650250, 10650251, 10652470, 10652471, 10652472, 10652473, 10652474, 10652475, 10652477, 10652479, 10659763, 10659764, 10663359, 10663361, 10663363, 10670118, 10670122, 10670123, 10670124, 10671920, 10671921, 10671922, 10671923, 10671925, 10680535, 10680536, 10680538, 10680539, 10680540, 10683369, 10683370, 10683371, 10683372, 10688155, 10688156, 10688157, 10688158, 10688159, 10688160, 10694256, 10694258, 10694260, 10694262, 10694264, 10694266, 10694268, 10694270, 10694272, 10694273, 10694274, 10694275, 10694296, 10712284, 10712285, 10716549, 10716551, 10716552, 10716553, 10716554, 10727906, 10727907, 10727908, 10727909, 10727910, 10727911, 10727912, 10748553, 10748554, 10748556, 10748557, 10771409, 10771411, 10771412, 10773388, 10773389, 10773390, 10773391, 10773392, 10773393, 10773394, 10776304, 10776308, 10776310, 10776316, 10776317, 10783737, 10783738, 10783739, 10783740, 10783741, 10788706, 10788707, 10788708, 10788709, 10788710, 10788711, 10816789, 10816790, 10816791, 10817064, 10817065, 10821308, 10821309, 10821310, 10828333, 10828334, 10828335, 10828336, 10828337, 10832541, 10832543, 10832544, 10832545, 10832547, 10832548, 10834958, 10834959, 10834960, 10834961, 10834962, 10834963, 10834964, 10834965, 10834966, 10834967, 10834968, 10834969, 10875109, 10875110, 10875111, 10875112, 10875113, 10877738, 10877739, 10877740, 10877742, 10877743, 10877744, 10879671, 10879672, 10879673, 10879674, 10879676, 10879677, 10879678, 10879679, 10879680, 10879682, 10879683, 10879684, 10879685, 10879686, 10879687, 10896069, 10896070, 10896071, 10911663, 10911665, 10911667, 10911669, 10911671, 10911675, 10941952, 10941953, 10941954, 10941955, 10941956, 10947110, 10947111, 10947112, 10947113, 10947114, 10947603, 10947604, 10947605, 10947607, 10947608, 10952744, 10952746, 10952747, 10952749, 10952750, 10956143, 10956144, 10956145, 10960853, 10985404, 10985408, 10985409, 10985410, 10989308, 10989309, 10989311, 11013097, 11013099, 11013100, 11013101, 9103442, 9143416, 9143417, 9174168, 9237175, 9237176, 9237177; 201-90010/10012019, 10012020, 10012021, 10012022, 10012023, 10012024, 10012025, 10012026, 10026482, 10026483, 10026484, 10026485, 10026486, 10026487, 10026488, 10026489, 10061666, 10061668, 10061669, 10061671, 10075586, 10075587, 10075588, 10082037, 10082039, 10082040, 10082041, 10106341, 10106342, 10106343, 10106344, 10114497, 10114499, 10114500, 10118096, 10118097, 10118098, 10118099, 10118100, 10118101, 10118102, 10118103, 10122160, 10122161, 10122162, 10122163, 10157219, 10157220, 10157221, 10184547, 10184548, 10184549, 10184551, 10184553, 10184554, 10184555, 10190508, 10190509, 10194010, 10214972, 10214973, 10234422, 10234423, 10234424, 10235052, 10250573, 10250574, 10250576, 10250577, 10256367, 10256368, 10256369, 10256370, 10256371, 10256372, 10256373, 10261919, 10261920, 10261921, 10261923, 10279769, 10333758, 10333759, 10333760, 10339372, 10339373, 10339374, 10343663, 10343664, 10343665, 10351697, 10351698, 10351699, 10379489, 10379490, 10379491, 10383826, 10383827, 10383828, 10383829, 10391724, 10391725, 10391726, 10391727, 10391730, 10391732, 10391733, 10413131, 10413132, 10413133, 10413135, 10413561, 10413565, 10413566, 10418562, 10462022, 10462023, 10462024, 10470479, 10470521, 10470524, 10472542, 10472550, 10474373, 10474374, 10474376, 10474377, 10498175, 10498176, 10501172, 10501173, 10503762, 10528582, 10543891, 10543892, 10552629, 10552630, 10552631, 10560591, 10560620, 10560621, 10560622, 10560623, 10560624, 10567338, 10567342, 10567343, 10567344, 10571082, 10571083, 10586726, 10586727, 10586728, 10591394, 10591395, 10591396, 10598036, 10598037, 10598038, 10598039, 10598040, 10602152, 10602153, 10602154, 10602155, 10602156, 10619564, 10619565, 10619566, 10619567, 10619568, 10621605, 10621606, 10621607, 10621608, 10621611, 10632450, 10632451, 10636575, 10640045, 10640050, 10640051, 10650671, 10650677, 10650680, 10650681, 10659755, 10659756, 10659757, 10659758, 10659759, 10659760, 10659761, 10663352, 10663353, 10663354, 10727899, 10727900, 10727901, 10727902, 10727903, 10727904, 10727905, 10735527, 10735528, 10735530, 10738501, 10739056, 10739065, 10739066, 10739067, 10739068, 10739069, 10739070, 10739071, 10739072, 10748571, 10748573, 10748574, 10778162, 10778164, 10778165, 10797739, 10797742, 10797746, 10815359, 10815362, 10815363, 10815364, 10816785, 10816786, 10816787, 10821305, 10821306, 10821307, 10828329, 10828330, 10828331, 10828332, 10828529, 10832540, 10835410, 10847295, 10847297, 10847298, 10847299, 10847300, 10847301, 10847302, 10847303, 10858660, 10858661, 10859392, 10859400, 10859403, 10859406, 10859407, 10872106, 10872108, 10872109, 10872111, 10872113, 10875119, 10875123, 10875126, 10875128, 10877758, 10877759, 10877760, 10893762, 10893763, 10893764, 10893765, 10893768, 10893769, 11001344, 11001345, 11001347, 9088894, 9088895, 9088897, 9088898, 9088899, 9088900, 9188312, 9230175, 9239396, 9239397, 9239398, 9239879, 9239880, 9239883, 9251990, 9251991, 9251992, 9251993; 201-90016/10104959, 10109004, 10148485, 10148517, 10195550, 10395893, 10477785, 10528583, 10560573, 10579395, 10579396, 10630119, 10665672, 10916780, 10916781, 10969131, 9163847, 9239394; CMAEK00/CMAEK00(20236575, 20236576, 20236577, 20236578, 20236579, 20236580, 20236581, 20236582, 20236583, 20236584, 20236585, 20236586, 20236587, 20236588, 20236589, 20236590, 20236591, 20236592), 10438711(20236593, 20236594, 20236595, 20236596, 20236597, 20236598, 20236599, 20236600, 20236601, 20236602, 20236603, 20236604, 20236605, 20236607, 20236608, 20236609, 20236610), 10451609(20236611, 20236612, 20236613, 20236614, 20236615, 20236616, 20236617, 20236619, 20236620, 20236621, 20236622, 20236623, 20236624, 20236625, 20236626, 20236627, 20236628), 10451610(20256947, 20256948, 20256949, 20256950, 20256951, 20256952, 20256953, 20256955, 20256956, 20256957, 20256958, 20256959, 20256960, 20256961, 20256962, 20256963, 20256964), 10451615(20256965, 20256966, 20256967, 20256968, 20256969, 20256970, 20256971, 20256972, 20256973, 20256974, 20256975, 20256976, 20256977, 20256978, 20256979, 20256980, 20256982), 10451617(20256983, 20256984, 20256985, 20256986, 20256987, 20256988, 20256989, 20256990, 20256991, 20256992, 20256993, 20256994, 20256995, 20256996, 20256997, 20256998, 20256999, 20257000), 10463759(20278309, 20278310, 20278311, 20278312, 20278313, 20278314, 20278315, 20278316, 20278317, 20278318, 20278319, 20278320, 20278321, 20278322, 20278323, 20278324, 20278325, 20278326), 10463760(20278327, 20278328, 20278329, 20278330, 20278331, 20278332, 20278333, 20278334, 20278335, 20278336, 20278337, 20278338, 20278339, 20278340, 20278341, 20278342, 20278343, 20278344), 10552471(20278363 20278365, 20278366, 20278367, 20278368, 20278369, 20278370, 20278371, 20278372, 20278373, 20278374, 20278375, 20278376, 20278377, 20278378, 20278379, 20278380), 10552472(20278345, 20278346, 20278348, 20278349, 20278350, 20278351, 20278352, 20278353, 20278354, 20278355, 20278356, 20278357, 20278358, 20278359, 20278360, 20278361, 20278362), 10552475(20278381, 20278382, 20278383, 20278384, 20278385, 20278386, 20278387, 20278388, 20278389, 20278390, 20278391, 20278392, 20278394, 20278395, 20278396, 20278397, 20278398), 10552484(20284132, 20284133, 20284134, 20284136, 20284137, 20284138, 20284139, 20284141, 20284142, 20284143, 20284144, 20284145, 20284146, 20284147, 20284148, 20284149), 10552486(20284114, 20284115, 20284116, 20284117, 20284118, 20284119, 20284120, 20284121, 20284122, 20284123, 20284124, 20284125, 20284126, 20284127, 20284128, 20284129, 20284130, 20284131), 10552487(20342251, 20342252, 20342253, 20342254, 20342255, 20342256, 20342257, 20342258, 20342259, 20342260, 20342261, 20342262, 20342263, 20342264, 20342265, 20342266, 20342267, 20342268), 10574868(20302808, 20302810, 20302811, 20302812, 20302813, 20302814, 20302815, 20302816, 20302817, 20302818, 20302819, 20302820, 20302821, 20302822, 20302823, 20302824, 20302825), 10574869(20302714, 20302715, 20302716, 20302717, 20302718, 20302719, 20302720, 20302721, 20302722, 20302723, 20302724, 20302725, 20302726, 20302727, 20302728, 20302729, 20302730, 20302731), 10574872(20302732, 20302733, 20302734, 20302735, 20302736, 20302737, 20302738, 20302739, 20302740, 20302741, 20302742, 20302743, 20302744, 20302745, 20302746, 20302747, 20302748, 20302749), 10574873(20302750, 20302751, 20302752, 20302753, 20302754, 20302755, 20302756, 2...

Label field

Details supplied by the agency

Lot, code or applicability

UDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers. REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 10235019, 10235024, 10245539, 10245540, 10245541, 10245542, 10245543, 10256365, 10256366, 10289217, 10289218, 10291590, 10291591, 10301036, 10301037, 10301038, 10301039, 10301040, 10301041, 10301042, 10301043, 10301044, 10303473, 10303476, 10303477, 10303478, 10325561, 10341677, 10342238 10343635, 10343636, 10343637, 10343638, 10343639, 10343640, 10351700, 10351701, 10351702, 10351703, 10351704, 10351707, 10359524, 10359525, 10359526, 10359527, 10359528, 10359529, 10359530, 10359531, 10359532, 10371222, 10371223, 10371224, 10371225, 10371226, 10373595, 10373596, 10373597, 10373598, 10373599, 10391563, 10391564, 10391565, 10391566, 10398007, 10398008, 10398009, 10398010, 10398011, 10399853, 10399854, 10399855, 10399856, 10399857, 10399858, 10399859, 10399860, 10399861, 10399862, 10399866, 10399867, 10410026, 10410027, 10410028, 10410197, 10410198, 10410199, 10411641, 10411642, 10414322, 10414323, 10414324, 10414325, 10414326, 10416065, 10416066, 10416067, 10418871, 10419212, 10424524, 10428901, 10428902, 10428904, 10428905, 10428906, 10456505, 10456506, 10456507, 10456508, 10456509, 10457499, 10457500, 10457502, 10464083, 10464085, 10464086, 10464092, 10498116, 10498117, 10498118, 10517215, 10518978, 10518979, 10518980, 10518981, 10518982, 10528585, 10528587, 10528588, 10530704, 10530705, 10530706, 10535290, 10535294, 10535297, 10535299, 10535300, 10535302, 10541032, 10541033, 10541034, 10541035, 10543873, 10543874, 10550324, 10550325, 10550326, 10550328, 10550329, 10560628, 10560629, 10560630, 10567320, 10567321, 10567322, 10567323, 10571084, 10571085, 10571086, 10571087, 10571088, 10571090, 10588824, 10588825, 10588826, 10591390, 10591391, 10591392, 10591393, 10602157, 10602160, 10602161, 10602162, 10602163, 10602164, 10623578, 10623579, 10623581, 10623582, 10623583, 10632619, 10632625, 10632630, 10639955, 10639956, 10639957, 10639959, 10639960, 10646446, 10646447, 10646449, 10646450, 10646451, 10646452, 10650250, 10650251, 10652470, 10652471, 10652472, 10652473, 10652474, 10652475, 10652477, 10652479, 10659763, 10659764, 10663359, 10663361, 10663363, 10670118, 10670122, 10670123, 10670124, 10671920, 10671921, 10671922, 10671923, 10671925, 10680535, 10680536, 10680538, 10680539, 10680540, 10683369, 10683370, 10683371, 10683372, 10688155, 10688156, 10688157, 10688158, 10688159, 10688160, 10694256, 10694258, 10694260, 10694262, 10694264, 10694266, 10694268, 10694270, 10694272, 10694273, 10694274, 10694275, 10694296, 10712284, 10712285, 10716549, 10716551, 10716552, 10716553, 10716554, 10727906, 10727907, 10727908, 10727909, 10727910, 10727911, 10727912, 10748553, 10748554, 10748556, 10748557, 10771409, 10771411, 10771412, 10773388, 10773389, 10773390, 10773391, 10773392, 10773393, 10773394, 10776304, 10776308, 10776310, 10776316, 10776317, 10783737, 10783738, 10783739, 10783740, 10783741, 10788706, 10788707, 10788708, 10788709, 10788710, 10788711, 10816789, 10816790, 10816791, 10817064, 10817065, 10821308, 10821309, 10821310, 10828333, 10828334, 10828335, 10828336, 10828337, 10832541, 10832543, 10832544, 10832545, 10832547, 10832548, 10834958, 10834959, 10834960, 10834961, 10834962, 10834963, 10834964, 10834965, 10834966, 10834967, 10834968, 10834969, 10875109, 10875110, 10875111, 10875112, 10875113, 10877738, 10877739, 10877740, 10877742, 10877743, 10877744, 10879671, 10879672, 10879673, 10879674, 10879676, 10879677, 10879678, 10879679, 10879680, 10879682, 10879683, 10879684, 10879685, 10879686, 10879687, 10896069, 10896070, 10896071, 10911663, 10911665, 10911667, 10911669, 10911671, 10911675, 10941952, 10941953, 10941954, 10941955, 10941956, 10947110, 10947111, 10947112, 10947113, 10947114, 10947603, 10947604, 10947605, 10947607, 10947608, 10952744, 10952746, 10952747, 10952749, 10952750, 10956143, 10956144, 10956145, 10960853, 10985404, 10985408, 10985409, 10985410, 10989308, 10989309, 10989311, 11013097, 11013099, 11013100, 11013101, 9103442, 9143416, 9143417, 9174168, 9237175, 9237176, 9237177; 201-90010/10012019, 10012020, 10012021, 10012022, 10012023, 10012024, 10012025, 10012026, 10026482, 10026483, 10026484, 10026485, 10026486, 10026487, 10026488, 10026489, 10061666, 10061668, 10061669, 10061671, 10075586, 10075587, 10075588, 10082037, 10082039, 10082040, 10082041, 10106341, 10106342, 10106343, 10106344, 10114497, 10114499, 10114500, 10118096, 10118097, 10118098, 10118099, 10118100, 10118101, 10118102, 10118103, 10122160, 10122161, 10122162, 10122163, 10157219, 10157220, 10157221, 10184547, 10184548, 10184549, 10184551, 10184553, 10184554, 10184555, 10190508, 10190509, 10194010, 10214972, 10214973, 10234422, 10234423, 10234424, 10235052, 10250573, 10250574, 10250576, 10250577, 10256367, 10256368, 10256369, 10256370, 10256371, 10256372, 10256373, 10261919, 10261920, 10261921, 10261923, 10279769, 10333758, 10333759, 10333760, 10339372, 10339373, 10339374, 10343663, 10343664, 10343665, 10351697, 10351698, 10351699, 10379489, 10379490, 10379491, 10383826, 10383827, 10383828, 10383829, 10391724, 10391725, 10391726, 10391727, 10391730, 10391732, 10391733, 10413131, 10413132, 10413133, 10413135, 10413561, 10413565, 10413566, 10418562, 10462022, 10462023, 10462024, 10470479, 10470521, 10470524, 10472542, 10472550, 10474373, 10474374, 10474376, 10474377, 10498175, 10498176, 10501172, 10501173, 10503762, 10528582, 10543891, 10543892, 10552629, 10552630, 10552631, 10560591, 10560620, 10560621, 10560622, 10560623, 10560624, 10567338, 10567342, 10567343, 10567344, 10571082, 10571083, 10586726, 10586727, 10586728, 10591394, 10591395, 10591396, 10598036, 10598037, 10598038, 10598039, 10598040, 10602152, 10602153, 10602154, 10602155, 10602156, 10619564, 10619565, 10619566, 10619567, 10619568, 10621605, 10621606, 10621607, 10621608, 10621611, 10632450, 10632451, 10636575, 10640045, 10640050, 10640051, 10650671, 10650677, 10650680, 10650681, 10659755, 10659756, 10659757, 10659758, 10659759, 10659760, 10659761, 10663352, 10663353, 10663354, 10727899, 10727900, 10727901, 10727902, 10727903, 10727904, 10727905, 10735527, 10735528, 10735530, 10738501, 10739056, 10739065, 10739066, 10739067, 10739068, 10739069, 10739070, 10739071, 10739072, 10748571, 10748573, 10748574, 10778162, 10778164, 10778165, 10797739, 10797742, 10797746, 10815359, 10815362, 10815363, 10815364, 10816785, 10816786, 10816787, 10821305, 10821306, 10821307, 10828329, 10828330, 10828331, 10828332, 10828529, 10832540, 10835410, 10847295, 10847297, 10847298, 10847299, 10847300, 10847301, 10847302, 10847303, 10858660, 10858661, 10859392, 10859400, 10859403, 10859406, 10859407, 10872106, 10872108, 10872109, 10872111, 10872113, 10875119, 10875123, 10875126, 10875128, 10877758, 10877759, 10877760, 10893762, 10893763, 10893764, 10893765, 10893768, 10893769, 11001344, 11001345, 11001347, 9088894, 9088895, 9088897, 9088898, 9088899, 9088900, 9188312, 9230175, 9239396, 9239397, 9239398, 9239879, 9239880, 9239883, 9251990, 9251991, 9251992, 9251993; 201-90016/10104959, 10109004, 10148485, 10148517, 10195550, 10395893, 10477785, 10528583, 10560573, 10579395, 10579396, 10630119, 10665672, 10916780, 10916781, 10969131, 9163847, 9239394; CMAEK00/CMAEK00(20236575, 20236576, 20236577, 20236578, 20236579, 20236580, 20236581, 20236582, 20236583, 20236584, 20236585, 20236586, 20236587, 20236588, 20236589, 20236590, 20236591, 20236592), 10438711(20236593, 20236594, 20236595, 20236596, 20236597, 20236598, 20236599, 20236600, 20236601, 20236602, 20236603, 20236604, 20236605, 20236607, 20236608, 20236609, 20236610), 10451609(20236611, 20236612, 20236613, 20236614, 20236615, 20236616, 20236617, 20236619, 20236620, 20236621, 20236622, 20236623, 20236624, 20236625, 20236626, 20236627, 20236628), 10451610(20256947, 20256948, 20256949, 20256950, 20256951, 20256952, 20256953, 20256955, 20256956, 20256957, 20256958, 20256959, 20256960, 20256961, 20256962, 20256963, 20256964), 10451615(20256965, 20256966, 20256967, 20256968, 20256969, 20256970, 20256971, 20256972, 20256973, 20256974, 20256975, 20256976, 20256977, 20256978, 20256979, 20256980, 20256982), 10451617(20256983, 20256984, 20256985, 20256986, 20256987, 20256988, 20256989, 20256990, 20256991, 20256992, 20256993, 20256994, 20256995, 20256996, 20256997, 20256998, 20256999, 20257000), 10463759(20278309, 20278310, 20278311, 20278312, 20278313, 20278314, 20278315, 20278316, 20278317, 20278318, 20278319, 20278320, 20278321, 20278322, 20278323, 20278324, 20278325, 20278326), 10463760(20278327, 20278328, 20278329, 20278330, 20278331, 20278332, 20278333, 20278334, 20278335, 20278336, 20278337, 20278338, 20278339, 20278340, 20278341, 20278342, 20278343, 20278344), 10552471(20278363 20278365, 20278366, 20278367, 20278368, 20278369, 20278370, 20278371, 20278372, 20278373, 20278374, 20278375, 20278376, 20278377, 20278378, 20278379, 20278380), 10552472(20278345, 20278346, 20278348, 20278349, 20278350, 20278351, 20278352, 20278353, 20278354, 20278355, 20278356, 20278357, 20278358, 20278359, 20278360, 20278361, 20278362), 10552475(20278381, 20278382, 20278383, 20278384, 20278385, 20278386, 20278387, 20278388, 20278389, 20278390, 20278391, 20278392, 20278394, 20278395, 20278396, 20278397, 20278398), 10552484(20284132, 20284133, 20284134, 20284136, 20284137, 20284138, 20284139, 20284141, 20284142, 20284143, 20284144, 20284145, 20284146, 20284147, 20284148, 20284149), 10552486(20284114, 20284115, 20284116, 20284117, 20284118, 20284119, 20284120, 20284121, 20284122, 20284123, 20284124, 20284125, 20284126, 20284127, 20284128, 20284129, 20284130, 20284131), 10552487(20342251, 20342252, 20342253, 20342254, 20342255, 20342256, 20342257, 20342258, 20342259, 20342260, 20342261, 20342262, 20342263, 20342264, 20342265, 20342266, 20342267, 20342268), 10574868(20302808, 20302810, 20302811, 20302812, 20302813, 20302814, 20302815, 20302816, 20302817, 20302818, 20302819, 20302820, 20302821, 20302822, 20302823, 20302824, 20302825), 10574869(20302714, 20302715, 20302716, 20302717, 20302718, 20302719, 20302720, 20302721, 20302722, 20302723, 20302724, 20302725, 20302726, 20302727, 20302728, 20302729, 20302730, 20302731), 10574872(20302732, 20302733, 20302734, 20302735, 20302736, 20302737, 20302738, 20302739, 20302740, 20302741, 20302742, 20302743, 20302744, 20302745, 20302746, 20302747, 20302748, 20302749), 10574873(20302750, 20302751, 20302752, 20302753, 20302754, 20302755, 20302756, 2...

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 - US Nationwide distribution including in the states of MN, PA, OK, FL, CA, OR, IL, NY, DE, GA, NJ, NC, WI, OH, AZ, AR, TX, TN, MO, MA, MT, KY, NE, WV, VA, ME, ND, AL, CO, DC, MS, IN, MI, CT, SC, WA, NM, MD, HI, ID, IA, LA, UT, RI, NV and the countries of Algeria, Australia, Austria, Bahrain, CANADA, Cayman Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Italy, Jordan, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Oman, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

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: Jan 21, 2026
Recall initiation date: Oct 10, 2025
Center classification date: Jan 15, 2026

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