Recall archive / FDA device enforcement

Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600... — FDA record Z-1272-2022

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 Apr 18, 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: Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1
Reason: Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
Classification: Class I
Recalling firm: Smiths Medical ASD Inc.
Quantity: 65093 units
Agency-reported status: Ongoing
Source record identifier: Z-1272-2022

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 3500: No UDI, Serial Numbers: Model 3500: No UDI, Serial Numbers: M63658, M36749, M16998, M31819, M62715, M62716, M29795, M21251, M32302, M31248, M31839, M29543, M22299, M34554, M29749, M22179, M25875, M21234, M28137, M31041, M29706, M23786, M62354, M23774, M23778, M24318, M31709, M62633, M29883, M20907, M32080, M24983, M30672, M30681, M31390, M31714, M62349, M63113, M34559, M63122, M31838, M41492, M29612, M63639, M27898, M41481, M22427, M21834, M33123, M62589, M27729, M21711, M25684, M25667, M23784, M24070, M24474, M41485, M25890, M32006, M21197, M26866, M21209, M25481, M26336, M26868, M26859, M21233, M22286, M30821, M27632, M21236, M21263, M21265, M21287, M27636, M27655, M28438, M28475, M27821, M23202, M28443, M21268, M24319, M21244, M34586, M21261, M25547, M28101, M21290, M30815, M26467, M34593, M34894, M22888, M26101, M37713, M63645, M62306, M30205, M21681, M22012, M22013, M27635, M21661, M27547, M34197, M27641, M27644, M27656, M27658, M26100, M32056, M23204, M30626, M22393, M31434, M25507, M31316, M28471, M28235, M28481, M25406, M22478, M25450, M21258, M28234, M30818, M30600, M24436, M21247, M29500, M36970, M27460, M22896, M24431, M25462, M22885, M22890, M22488, M34791, M25457, M25469, M25478, M25487, M25488, M25495, M25574, M29550, M30983, M23915, M62640, M34440, M31716, M62593, M63121, M27824, M34928, M24408, M27617, M21645, M30438, M26448, M30629, M23879, M24130, M22693, M22392, M30642, M31845, M26680, M31710, M26588, M31389, M21614, M21898, M21899, M32223, M21918, M26464, M63162, M26355, M25681, M26268, M26286, M27075, M32051, M26323, M27013, M27032, M27059, M30830, M36944, M28507, M34441, M21322, M22880, M24199, M25700, M62546, M62370, M34882, M27008, M62554, M26494, M27730, M26160, M26508, M27010, M62586, M26332, M62378, M30113, M30833, M25940, M26222, M32857, M63656, M29760, M24101, M26156, M26496, M33228, M26200, M26219, M26299, M26495, M24487, M26512, M62588, M62691, M62688, M26865, M62686, M26846, M62695, M28147, M21174, M31731, M30835, M62697, M25720, M26282, M23119, M37135, M26111, M26260, M26326, M27226, M27752, M21201, M25659, M25668, M26325, M26915, M27188, M27232, M26184, M26295, M28119, M21182, M26854, M39782, M37170, M33041, M34576, M31989, M21215, M33370, M22428, M25454, M20706, M30832, M25464, M21643, M29665, M29553, M32820, M30992, M31735, M31039, M62685, M32303, M32298, M33155, M36958, M25973, M36933, M31014, M23215, M32792, M24129, M22256, M21880, M22443, M32027, M30809, M21282, M30441, M24311, M22470, M41489, M23880, M24310, M37798, M35144, M25974, M34839, M32819, M30882, M37326, M28259, M26433, M21855, M22480, M28111, M24795, M63123, M62735, M26393, M30680, M28100, M21387, M31749, M29828, M34604, M28099, M32787, M21389, M25937, M34578, M32299, M62726, M21332, M22455, M31370, M21384, M32821, M22456, M24137, M33447, M34592, M24451, M34567, M24405, M28174, M21278, M62611, M63136, M62563, M63138, M28422, M34784, M23788, M34786, M30879, M31726, M34603, M28252, M28257, M34762, M34582, M36965, M36943, M36948, M26411, M37117, M25236, M34744, M21385, M26430, M23882, M30047, M26458, M26462, M28263, M26410, M26460, M26481, M59266, M34194, M26391, M26566, M20707, M33126, M26813, M20701, M32052, M26806, M26839, M27861, M21264, M28224, M28228, M28231, M25451, M25733, M27042, M32967, M34763, M27664, M23201, M25714, M37850, M34758, M28153, M34754, M33162, M28110, M59264, M59273, M32398, M25883, M33163, M28144, M34816, M28347, M28563, M34823, M32636, M26032, M34590, M22172, M33673, M36696, M26034, M21903, M63647, M21226, M33484, M23883, M37165, M21224, M34430, M34373, M31708, M27041, M20713, M30998, M62596, M21218, M37115, M62623, M34583, M23209, M25740, M23199, M24480, M22202, M24473, M28419, M62681, M24444, M30813, M32224, M62693, M62696, M22465, M29588, M30207, M33169, M36920, M22285, M22289, M22292, M27652, M59274, M33295, M21839, M30606, M36748, M23191, M30984, M21879, M31306, M24801, M25949, M24144, M30834, M31287, M34563, M21227, M33831, M21392, M26844, M32252, M34822, M21636, M26672, M26158, M30610, M24403, M24406, M33121, M34383, M32896, M32897, M23487, M26681, M22440, M21732, M33739, M24031, M24923, M32025, M36964, M21390, M27702, M36917, M37770, M21388, M21394, M32893, M30892, M30637, M23206, M24869, M37933, M25910, M23118, M30679, M21501, M36919, M23792, M34364, M28453, M29643, M37651, M31713, M22389, M32965, M37636, M21383, M31711, M37928, M21613, M29650, M33137, M32781, M34827, M34832, M59265, M32384, M31706, M63129, M32742, M23846, M26035, M26040, M31833, M32960, M62310, M27725, M27726, M37990, M34885, M34891, M34562, M21465, M32327, M36947, M31035, M21435, M33803, M34564, M27856, M27738, M32892, M21407, M24165, M27739, M32895, M32898, M23884, M22889, M34951, M24864, M33828, M26472, M62328, M30817, M26033, M28157, M26172, M37116, M36954, M28151, M36961, M37460, M29580, M21425, M30539, M27173, M29817, M31723, M31960, M34599, M22436, M35168, M30811, M59267, M21379, M27911, M21856, M24803, M36959, M29731, M29763, M31853, M09583, M31377, M29688, M31456, M30643, M24434, M33138, M21319, M31275, M32167, M37291, M29599, M20166, M24998, M22011, M31134, M31260, M29592, M36922, M24979, M27246, M30814, M36955, M22454, M22471, M41064, M23910, M22397, M20928, M21475, M29619, M37613, M24766, M30219, M23734, M31499, M30620, M24147, M22415, M31126, M28521, M63659, M32647, M32342, M36956, M36966, M31373, M34551, M30673, M28446, M28493, M31998, M27849, M21444, M31979, M32083, M30603, M33166, M32970, M36942, M29697, M27021, M32300, M31742, M28454, M26684, M24143, M32297, M31382, M23116, M23777, M32961, M62569, M37356, M26147, M23858, M37051, M28468, M21391, M29692, M31952, M32064, M28376, M31967, M28458, M24802, M28467, M25458, M22257, M39766, M41482, M20716, M63665, M36972, M29787, M29674, M29723, M22432, M34591, M30816, M34597, M34601, M22897, M37275, M26344, M37131, M29816, M31172, M22438, M28504, M28447, M28511, M31740, M34842, M26836, M24866, M28191, M28198, M31012, M31006, M22399, M31077, M33133, M27053, M28363, M22201, M22434, M41483, M31790, M62674, M21148, M27039, M62678, M62680, M62694, M37357, M36973, M21706, M28378, M23022, M22893, M26794, M31315, M28414, M32347, M34761, M21238, M32629, M25559, M29583, M27792, M34830, M34845, M34918, M37935, M25590, M26586, M30665, M26482, M26694, M37456, M37478, M32974, M28488, M25553, M34922, M31186, M28500, M30229, M21170, M21380, M30611, M34907, M63671, M25680, M32245, M20988, M36969, M21705, M29366, M29603, M37883, M27853, M28128, M25672, M30797, M34560, M36926, M28381, M21430, M29736, M30918, M34566, M62679, M23845, M22460, M33161, M62684, M23046, M27581, M22302, M33164, M23909, M34770, M30666, M21679, M23773, M34569, M24463, M24055, M25532, M29587, M29590, M24065, M30640, M27776, M27787, M34423, M21237, M29677, M26318, M20895, M27777, M34579, M34417, M22431, M32253, M37264, M26114, M37712, M24804, M25925, M36934, M33124, M32220, M34577, M34921, M20704, M34785, M37768, M34750, M62287, M62369, M62380, M25531, M20886, M20894, M21240, M30641, M62288, M62376, M20887, M20888, M20892, M20896, M20903, M23797, M62290, M62316, M62371, M32117, M20703, M62322, M62591, M62343, M62355, M62609, M28483, M26174, M25245, M30808, M27149, M22405, M22569, M62387, M31970, M37502, M24817, M21386, M30801, M31958, M22904, M28549, M25551, M21803, M31738, M30978, M34888, M22409, M25926, M62379, M24039, M20882, M20883, M20891, M20899, M20905, M36951, M63115, M28441, M28489, M62666, M62372, M30608, M30831, M21286, M28461, M31795, M31806, M31809, M31811, M37363, M25944, M21686, M37359, M30619, M32937, M36963, M21691, M30894, M23785, M31802, M31805, M31902, M31986, M32344, M24500, M25569, M34843, M34846, M28161, M24064, M21267, M22886, M26063, M26077, M28764, M30979, M30442, M31013, M31969, M31980, M25935, M62313, M62558, M62560, M30440, M62384, M62649, M62308, M62311, M62351, M62603, M62620, M63131, M32400, M62274, M21254, M62296, M62557, M62626, M33141, M31718, M37612, M36697, M62307, M62345, M62544, M32081, M32092, M31703, M32018, M25957, M20911, M32219, M26679, M27166, M32022, M32030, M34734, M24057, M23205, M32039, M27507, M27514, M30435, M28985, M34767, M31791, M31894, M31929, M31957, M31964, M31976, M31988, M32066, M32070, M32100, M32103, M32106, M32108, M32112, M30819, M34899, M26528, M63666, M62348, M62644, M63130, M24056, M26808, M23198, M25412, M27096, M33142, M24855, M62668, M22235, M30663, M27745, M27462, M32171, M26003, M37136, M32194, M29805, M24797, M32208, M28379, M32204, M32856, M31379, M62619, M21285, M32977, M62312, M62547, M24433, M31666, M37841, M37102, M34789, M37800, M37108, M31912, M32095, M32114, M32337, M32345, M62703, M37860, M37836, M37927, M37265, M34831, M31982, M31023, M27775, M28152, M34555, M21242, M27742, M27458, M30430, M29359, M31789, M31794, M31800, M31804, M31808, M32626, M32657, M37685, M21663, M27683, M32031, M32023, M22467, M32033, M24328, M24246, M34425, M28550, M37994, M32186, M24314, M32550, M24505, M25391, M25710, M24127, M26223, M24142, M31787, M34580, M29569, M32078, M25997, M29596, M32173, M31891, M21890, M62683, M25542, M21502, M28774, M36935, M36950, M36960, M32207, M30675, M23854, M36974, M27667, M21647, M27791, M25546, M30627, M26224, M25998, M36941, M30664, M23835, M28390, M36925, M21147, M37646, M31968, M20733, M24863, M28611, M32099, M32174, M37360, M22895, M28384, M28650, M31657, M22014, M34751, M29362, M28417, M29545, M23156, M31905, M31915, M37635, M32628, M26012, M22197, M28890, M37459, M31722, M34428, M41054, M21020, M33297, M21473, M34813, M24254, M24035, M26569, M32548, M37475, M28375, M22550, M36918, M36928, M23771, M20693, M29789, M34424, M33498, M34819, M24268, M21269, M21257, M29829, M29831, M21774, M28556, M21757, M34700, M30810, M30820, M31737, M28895, M27228, M34824, M34837, M34884, M28851, M21729, M26447, M26465, M26552, M26578, M28897, M37799, M21739, M26469, M26561, M26302, M27243, M26952, M24448, M30644, M21178, M25699, M37033, M27516, M63660, M22884, M33135, M30648, M32343, M34570, M34995, M28539, M28561, M20106, M21175, M26861, M31061, M28562, M24099, M37133, M30616, M33129, M31844, M21488, M28386, M30812, M34585, M24861, M31487, M24098, M24050, M36689, M31504, M37134, M21927, M62692, M21204, M25607, M26401, M26414, M27153, M20884, M31447, M31452, M31514, M31541, M37692, M29605, M24036, M26516, M28342, M30202, M27521, M32221, M32447, M21393, M33140, M36945, M34363, M21284, M23881, M20718, M34360, M34374, M34377, M34380, M34392, M37753, M28547, M30694, M30222, M26066, M26075, M22881, M21789, M37355, M37358, M37364, M63638, M28568, M34355, M34358, M34378, M28564, M24873, M34369, M26082, M26088, M31166, M24325, M24796, M29591, M21731, M21802, M28551, M27695, M34772, M32966, M27753, M29818, M27517, M37774, M36937, M37682, M34215, M25655, M27510, M62727, M21670, M21762, M27006, M26055, M29813, M23810, M22015, M31319, M21482, M25971, M63667, M36968, M31027, M26212, M21618, M36924, M33099, M32222, M33455, M29593, M29656, M29270, M33457, M33458, M33462, M21932, M21801, M62734, M21317, M22463, M28374, M36962, M32329, M31063, M22835, M30484, M30625, M33654, M33880, M26070, M30980, M36530, M37757, M33681, M33883, M33952, M36055, M36106, M30959, M37083, M33912, M36588, M24472, M28377, M30969, M20872, M37503, M20835, M30968, M32453, M37172, M24110, M29638, M23019, M21941, M30668, M21904, M36213, M22883, M22437, M20711, M22833, M24170, M24332, M30639, M34741, M25650, M29423, M29882, M25554, M27171, M21945, M30604, M36953, M37438, M21944, M24452, M22091, M24119, M24107, M34595, M37467, M24111, M31311, M32975, M22564, M22566, M37479, M32058, M26150, M27455, M25399, M27855, M31244, M28143, M32660, M31728, M37827, M33456, M33459, M33460, M22430, M29260, M37046, M29727, M36148, M37501, M27688, M30678, M27615, M34682, M25616, M27453, M29361, M24067, M26440, M29335, M62667, M22570, M26883, M34948, M28299, M26662, M21442, M25490, M26409, M37470, M26397, M26418, M34887, M32191, M21675, M26480, M26678, M30824, M33494, M28463, M31400, M23078, M27749, M21707, M31401, M20976, M27191, M23095, M21725, M21222, M34787, M24409, M36946, M21767, M28382, M29589, M22453, M28113, M21710, M3371...

Label field

Details supplied by the agency

Lot, code or applicability

Model 3500: No UDI, Serial Numbers: Model 3500: No UDI, Serial Numbers: M63658, M36749, M16998, M31819, M62715, M62716, M29795, M21251, M32302, M31248, M31839, M29543, M22299, M34554, M29749, M22179, M25875, M21234, M28137, M31041, M29706, M23786, M62354, M23774, M23778, M24318, M31709, M62633, M29883, M20907, M32080, M24983, M30672, M30681, M31390, M31714, M62349, M63113, M34559, M63122, M31838, M41492, M29612, M63639, M27898, M41481, M22427, M21834, M33123, M62589, M27729, M21711, M25684, M25667, M23784, M24070, M24474, M41485, M25890, M32006, M21197, M26866, M21209, M25481, M26336, M26868, M26859, M21233, M22286, M30821, M27632, M21236, M21263, M21265, M21287, M27636, M27655, M28438, M28475, M27821, M23202, M28443, M21268, M24319, M21244, M34586, M21261, M25547, M28101, M21290, M30815, M26467, M34593, M34894, M22888, M26101, M37713, M63645, M62306, M30205, M21681, M22012, M22013, M27635, M21661, M27547, M34197, M27641, M27644, M27656, M27658, M26100, M32056, M23204, M30626, M22393, M31434, M25507, M31316, M28471, M28235, M28481, M25406, M22478, M25450, M21258, M28234, M30818, M30600, M24436, M21247, M29500, M36970, M27460, M22896, M24431, M25462, M22885, M22890, M22488, M34791, M25457, M25469, M25478, M25487, M25488, M25495, M25574, M29550, M30983, M23915, M62640, M34440, M31716, M62593, M63121, M27824, M34928, M24408, M27617, M21645, M30438, M26448, M30629, M23879, M24130, M22693, M22392, M30642, M31845, M26680, M31710, M26588, M31389, M21614, M21898, M21899, M32223, M21918, M26464, M63162, M26355, M25681, M26268, M26286, M27075, M32051, M26323, M27013, M27032, M27059, M30830, M36944, M28507, M34441, M21322, M22880, M24199, M25700, M62546, M62370, M34882, M27008, M62554, M26494, M27730, M26160, M26508, M27010, M62586, M26332, M62378, M30113, M30833, M25940, M26222, M32857, M63656, M29760, M24101, M26156, M26496, M33228, M26200, M26219, M26299, M26495, M24487, M26512, M62588, M62691, M62688, M26865, M62686, M26846, M62695, M28147, M21174, M31731, M30835, M62697, M25720, M26282, M23119, M37135, M26111, M26260, M26326, M27226, M27752, M21201, M25659, M25668, M26325, M26915, M27188, M27232, M26184, M26295, M28119, M21182, M26854, M39782, M37170, M33041, M34576, M31989, M21215, M33370, M22428, M25454, M20706, M30832, M25464, M21643, M29665, M29553, M32820, M30992, M31735, M31039, M62685, M32303, M32298, M33155, M36958, M25973, M36933, M31014, M23215, M32792, M24129, M22256, M21880, M22443, M32027, M30809, M21282, M30441, M24311, M22470, M41489, M23880, M24310, M37798, M35144, M25974, M34839, M32819, M30882, M37326, M28259, M26433, M21855, M22480, M28111, M24795, M63123, M62735, M26393, M30680, M28100, M21387, M31749, M29828, M34604, M28099, M32787, M21389, M25937, M34578, M32299, M62726, M21332, M22455, M31370, M21384, M32821, M22456, M24137, M33447, M34592, M24451, M34567, M24405, M28174, M21278, M62611, M63136, M62563, M63138, M28422, M34784, M23788, M34786, M30879, M31726, M34603, M28252, M28257, M34762, M34582, M36965, M36943, M36948, M26411, M37117, M25236, M34744, M21385, M26430, M23882, M30047, M26458, M26462, M28263, M26410, M26460, M26481, M59266, M34194, M26391, M26566, M20707, M33126, M26813, M20701, M32052, M26806, M26839, M27861, M21264, M28224, M28228, M28231, M25451, M25733, M27042, M32967, M34763, M27664, M23201, M25714, M37850, M34758, M28153, M34754, M33162, M28110, M59264, M59273, M32398, M25883, M33163, M28144, M34816, M28347, M28563, M34823, M32636, M26032, M34590, M22172, M33673, M36696, M26034, M21903, M63647, M21226, M33484, M23883, M37165, M21224, M34430, M34373, M31708, M27041, M20713, M30998, M62596, M21218, M37115, M62623, M34583, M23209, M25740, M23199, M24480, M22202, M24473, M28419, M62681, M24444, M30813, M32224, M62693, M62696, M22465, M29588, M30207, M33169, M36920, M22285, M22289, M22292, M27652, M59274, M33295, M21839, M30606, M36748, M23191, M30984, M21879, M31306, M24801, M25949, M24144, M30834, M31287, M34563, M21227, M33831, M21392, M26844, M32252, M34822, M21636, M26672, M26158, M30610, M24403, M24406, M33121, M34383, M32896, M32897, M23487, M26681, M22440, M21732, M33739, M24031, M24923, M32025, M36964, M21390, M27702, M36917, M37770, M21388, M21394, M32893, M30892, M30637, M23206, M24869, M37933, M25910, M23118, M30679, M21501, M36919, M23792, M34364, M28453, M29643, M37651, M31713, M22389, M32965, M37636, M21383, M31711, M37928, M21613, M29650, M33137, M32781, M34827, M34832, M59265, M32384, M31706, M63129, M32742, M23846, M26035, M26040, M31833, M32960, M62310, M27725, M27726, M37990, M34885, M34891, M34562, M21465, M32327, M36947, M31035, M21435, M33803, M34564, M27856, M27738, M32892, M21407, M24165, M27739, M32895, M32898, M23884, M22889, M34951, M24864, M33828, M26472, M62328, M30817, M26033, M28157, M26172, M37116, M36954, M28151, M36961, M37460, M29580, M21425, M30539, M27173, M29817, M31723, M31960, M34599, M22436, M35168, M30811, M59267, M21379, M27911, M21856, M24803, M36959, M29731, M29763, M31853, M09583, M31377, M29688, M31456, M30643, M24434, M33138, M21319, M31275, M32167, M37291, M29599, M20166, M24998, M22011, M31134, M31260, M29592, M36922, M24979, M27246, M30814, M36955, M22454, M22471, M41064, M23910, M22397, M20928, M21475, M29619, M37613, M24766, M30219, M23734, M31499, M30620, M24147, M22415, M31126, M28521, M63659, M32647, M32342, M36956, M36966, M31373, M34551, M30673, M28446, M28493, M31998, M27849, M21444, M31979, M32083, M30603, M33166, M32970, M36942, M29697, M27021, M32300, M31742, M28454, M26684, M24143, M32297, M31382, M23116, M23777, M32961, M62569, M37356, M26147, M23858, M37051, M28468, M21391, M29692, M31952, M32064, M28376, M31967, M28458, M24802, M28467, M25458, M22257, M39766, M41482, M20716, M63665, M36972, M29787, M29674, M29723, M22432, M34591, M30816, M34597, M34601, M22897, M37275, M26344, M37131, M29816, M31172, M22438, M28504, M28447, M28511, M31740, M34842, M26836, M24866, M28191, M28198, M31012, M31006, M22399, M31077, M33133, M27053, M28363, M22201, M22434, M41483, M31790, M62674, M21148, M27039, M62678, M62680, M62694, M37357, M36973, M21706, M28378, M23022, M22893, M26794, M31315, M28414, M32347, M34761, M21238, M32629, M25559, M29583, M27792, M34830, M34845, M34918, M37935, M25590, M26586, M30665, M26482, M26694, M37456, M37478, M32974, M28488, M25553, M34922, M31186, M28500, M30229, M21170, M21380, M30611, M34907, M63671, M25680, M32245, M20988, M36969, M21705, M29366, M29603, M37883, M27853, M28128, M25672, M30797, M34560, M36926, M28381, M21430, M29736, M30918, M34566, M62679, M23845, M22460, M33161, M62684, M23046, M27581, M22302, M33164, M23909, M34770, M30666, M21679, M23773, M34569, M24463, M24055, M25532, M29587, M29590, M24065, M30640, M27776, M27787, M34423, M21237, M29677, M26318, M20895, M27777, M34579, M34417, M22431, M32253, M37264, M26114, M37712, M24804, M25925, M36934, M33124, M32220, M34577, M34921, M20704, M34785, M37768, M34750, M62287, M62369, M62380, M25531, M20886, M20894, M21240, M30641, M62288, M62376, M20887, M20888, M20892, M20896, M20903, M23797, 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M37757, M33681, M33883, M33952, M36055, M36106, M30959, M37083, M33912, M36588, M24472, M28377, M30969, M20872, M37503, M20835, M30968, M32453, M37172, M24110, M29638, M23019, M21941, M30668, M21904, M36213, M22883, M22437, M20711, M22833, M24170, M24332, M30639, M34741, M25650, M29423, M29882, M25554, M27171, M21945, M30604, M36953, M37438, M21944, M24452, M22091, M24119, M24107, M34595, M37467, M24111, M31311, M32975, M22564, M22566, M37479, M32058, M26150, M27455, M25399, M27855, M31244, M28143, M32660, M31728, M37827, M33456, M33459, M33460, M22430, M29260, M37046, M29727, M36148, M37501, M27688, M30678, M27615, M34682, M25616, M27453, M29361, M24067, M26440, M29335, M62667, M22570, M26883, M34948, M28299, M26662, M21442, M25490, M26409, M37470, M26397, M26418, M34887, M32191, M21675, M26480, M26678, M30824, M33494, M28463, M31400, M23078, M27749, M21707, M31401, M20976, M27191, M23095, M21725, M21222, M34787, M24409, M36946, M21767, M28382, M29589, M22453, M28113, M21710, M3371...

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 including US Virgin Islands, Countries of: AE, AL, AT, AU, BE, BM, BN, BS, CA, CH, CL, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IR, IT, KR, KW, LB, LK, MU, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, TR, TT, VI, and VN.

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: Jun 29, 2022
Recall initiation date: Apr 18, 2022
Center classification date: Jun 21, 2022

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