CLASS I ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Model Number U226, Visionist Crt-p EL recalled by Boston Scientific

Boston Scientific is recalling Model Number U226, Visionist Crt-p EL. The recall was initiated on 20 Aug 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 00802526559457, Serial numbers: 700333, 700335, 700342, 700344, 700346, 700347, 700352, 700364, 700372, 700386, 700388, 700390, 700391, 700425, 700426, 700427, 700428, 700429, 700437, 700448, 700455, 700460, 700461, 700464, 700490, 700498, 700500, 700520, 700538, 700539, 700570, 700587, 700591, 700638, 700653, 700665, 700676, 700693, 700700, 700702, 700704, 700705, 700707, 700708, 700711, 700718, 700720, 700722, 700735, 700736, 700755, 700759, 700765, 700768, 700774, 700782, 700790, 700794, 700796, 700809, 700817, 700830, 700870, 700874, 700879, 700881, 700882, 700883, 700887, 700889, 700903, 700905, 700908, 700911, 700917, 700925, 700935, 700940, 700950, 700951, 700959, 700968, 700970, 700978, 700980, 700984, 700988, 700990, 700991, 700994, 700997, 701005, 701008, 701017, 701019, 701023, 701032, 701038, 701048, 701071, 701083, 701091, 701096, 701097, 701100, 701108, 701116, 701117, 701122, 701127, 701136, 701140, 701141, 701142, 701146, 701147, 701148, 701151, 701153, 701154, 701161, 701165, 701166, 701167, 701174, 701178, 701181, 701182, 701183, 701187, 701192, 701197, 701199, 701201, 701203, 701207, 701212, 701217, 701240, 701242, 701247, 701249, 701252, 701255, 701256, 701318, 701320, 701321, 701330, 701334, 701335, 701342, 701349, 701356, 701425, 701427, 701439, 701440, 701446, 701447, 701448, 701462, 701490, 701510, 701511, 701517, 701525, 701528, 701529, 701532, 701537, 701538, 701539, 701543, 701547, 701550, 701551, 701556, 701559, 701562, 701563, 701564, 701589, 701590, 701597, 701603, 701607, 701631, 701643, 701647, 701649, 701661, 701662, 701664, 701685, 701686, 701690, 701691, 701696, 701703, 701709, 701714, 701715, 701722, 701723, 701727, 701729, 701732, 701735, 701736, 701741, 701745, 701750, 701756, 701758, 701768, 701769, 701771, 701772, 701778, 701783, 701789, 701790, 701799, 701803, 701807, 701817, 701818, 701826, 701827, 700890, 700907, 700928, 700929, 700936. GTIN 00802526559464, Serial numbers: 100006, 100009, 100011, 100012, 100013, 100014, 100016, 100017, 100018, 100019, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100032, 100034, 100035, 100038, 100039, 100042, 100044, 100045, 100046, 100048, 100049, 100050, 100052, 100053, 100054, 100055, 100058, 100059, 100061, 100062, 100063, 100066, 100067, 100068, 100069, 100070, 100073, 100075, 100076, 100077, 100081, 100087, 100089, 100092, 100094, 100095, 100096, 100098, 100100, 100101, 100102, 100105, 100107, 100108, 100109, 100111, 100112, 100113, 100116, 100117, 100118, 100120, 100123, 100124, 100126, 100127, 100128, 100129, 100132, 100133, 100134, 100135, 100136, 700002, 700003, 700004, 700006, 700007, 700008, 700010, 700011, 700012, 700013, 700014, 700015, 700018, 700019, 700020, 700021, 700023, 700024, 700025, 700026, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700042, 700044, 700045, 700048, 700050, 700051, 700052, 700053, 700054, 700056, 700057, 700058, 700059, 700060, 700061, 700063, 700065, 700066, 700067, 700068, 700071, 700072, 700074, 700075, 700076, 700077, 700081, 700082, 700083, 700084, 700087, 700088, 700089, 700090, 700091, 700092, 700093, 700094, 700095, 700096, 700098, 700099, 700101, 700102, 700103, 700106, 700107, 700108, 700111, 700114, 700118, 700120, 700121, 700122, 700124, 700125, 700126, 700132, 700135, 700137, 700139, 700140, 700141, 700142, 700143, 700145, 700146, 700147, 700149, 700151, 700153, 700154, 700155, 700156, 700159, 700163, 700164, 700167, 700168, 700169, 700170, 700171, 700172, 700183, 700184, 700186, 700187, 700191, 700192, 700193, 700194, 700199, 700201, 700207, 700209, 700210, 700211, 700212, 700213, 700214, 700215, 700216, 700218, 700220, 700225, 700226, 700227, 700229, 700230, 700231, 700237, 700239, 700240, 700241, 700245, 700246, 700247, 700249, 700264, 700265, 700267, 700268, 700269, 700270, 700275, 700276, 700277, 700280, 700286, 700287, 700288, 700289, 700291, 700292, 700293, 700296, 700298, 700301, 700304, 700306, 700309, 700311, 700312, 700313, 700314, 700316, 700321, 700326, 700327, 700328, 700329, 700331, 700340, 700343, 700357, 700363, 700375, 700376, 700378, 700379, 700380, 700382, 700393, 700394, 700395, 700397, 700400, 700401, 700402, 700404, 700405, 700406, 700411, 700413, 700415, 700417, 700419, 700421, 700423, 700433, 700435, 700439, 700442, 700446, 700449, 700453, 700454, 700456, 700457, 700466, 700467, 700470, 700471, 700473, 700474, 700476, 700477, 700478, 700479, 700480, 700482, 700485, 700487, 700492, 700493, 700494, 700495, 700496, 700499, 700502, 700507, 700508, 700509, 700510, 700517, 700521, 700526, 700527, 700528, 700530, 700534, 700536, 700537, 700542, 700546, 700548, 700551, 700553, 700555, 700556, 700557, 700558, 700559, 700560, 700561, 700563, 700564, 700566, 700567, 700574, 700575, 700576, 700577, 700579, 700580, 700581, 700582, 700584, 700585, 700588, 700590, 700593, 700594, 700595, 700596, 700597, 700599, 700603, 700604, 700605, 700610, 700611, 700612, 700613, 700615, 700616, 700617, 700618, 700619, 700620, 700622, 700623, 700625, 700627, 700629, 700630, 700640, 700654, 700656, 700659, 700660, 700667, 700670, 700672, 700673, 700678, 700679, 700682, 700687, 700689, 700695, 700697, 700709, 700724, 700725, 700737, 700739, 700767, 700780, 700811, 700812, 700824, 700827, 700828, 700829, 700834, 700836, 700838, 700845, 700855, 700858, 700862, 700865, 700868, 700869, 700875, 700877, 700894, 700897, 700900, 700904, 700910, 700916, 700921, 700923, 700924, 700926, 700931, 700938, 700945, 700949, 700957, 700958, 700973, 700976, 700977, 700981, 700982, 700983, 700985, 700986, 700987, 700992, 701000, 701006, 701011, 701015, 701031, 701033, 701037, 701040, 701045, 701068, 701073, 701074, 701076, 701077, 701081, 701082, 701086, 701087, 701090, 701098, 701099, 701101, 701112, 701113, 701115, 701120, 701124, 701128, 701133, 701149, 701150, 701156, 701157, 701158, 701159, 701162, 701163, 701164, 701168, 701170, 701173, 701175, 701177, 701179, 701186, 701188, 701193, 701195, 701200, 701202, 701204, 701206, 701210, 701211, 701213, 701216, 701221, 701222, 701225, 701228, 701229, 701231, 701232, 701236, 701261, 701262, 701264, 701265, 701266, 701267, 701268, 701270, 701275, 701277, 701278, 701279, 701280, 701283, 701284, 701287, 701288, 701291, 701292, 701294, 701296, 701297, 701299, 701300, 701301, 701304, 701305, 701307, 701308, 701310, 701315, 701329, 701333, 701340, 701347, 701351, 701359, 701361, 701363, 701364, 701367, 701374, 701375, 701376, 701387, 701389, 701395, 701402, 701404, 701405, 701407, 701409, 701410, 701411, 701413, 701416, 701422, 701428, 701430, 701431, 701432, 701436, 701444, 701454, 701456, 701460, 701464, 701466, 701469, 701471, 701483, 701497, 701500, 701501, 701502, 701504, 701506, 701507, 701509, 701512, 701513, 701514, 701515, 701518, 701522, 701524, 701527, 701533, 701540, 701541, 701544, 701546, 701548, 701549, 701553, 701557, 701565, 701566, 701567, 701569, 701572, 701575, 701577, 701578, 701579, 701580, 701581, 701583, 701585, 701586, 701588, 701593, 701594, 701595, 701596, 701598, 701599, 701600, 701602, 701610, 701611, 701613, 701614, 701615, 701618, 701619, 701620, 701621, 701624, 701627, 701628, 701629, 701634, 701637, 701638, 701644, 701645, 701650, 701653, 701654, 701655, 701658, 701659, 701660, 701665, 701666, 701667, 701668, 701669, 701670, 701671, 701674, 701676, 701677, 701678, 701679, 701681, 701683, 701695, 701697, 701698, 701699, 701700, 701701, 701706, 701710, 701711, 701718, 701719, 701724, 701725, 701726, 701734, 701737, 701746, 701749, 701754, 701759, 701761, 701763, 701765, 701767, 701770, 701773, 701774, 701775, 701776, 701777, 701779, 701780, 701785, 701787, 701788, 701791, 701796, 701801, 701804, 701805, 701809, 701812, 701820, 701821. GTIN 00802526577123, Serial numbers: 100074, 100085, 100106, 700079, 700109, 700110, 700123, 700219, 700222, 700232, 700266, 700278, 700279, 700282, 700290, 700300, 700302, 700305, 700310, 700323, 700325, 700366, 700458, 700503, 700543, 700608, 700651, 700662, 700688, 700692, 700694, 700764, 700798, 700805, 700810, 700833, 700837, 700839, 700840, 700848, 700852, 700854, 700856, 700857, 700863, 700867, 700896, 700898, 700934, 700955, 700995, 701095, 701103, 701205, 701208, 701209, 701282, 701285, 701289, 701293, 701302, 701314, 701420, 701426, 701434, 701474, 701487, 701493, 701498, 701499, 701503, 701508, 701520, 701526, 701531, 701535, 701558, 701560, 701573, 701574, 701606, 701625, 701640, 701672, 701682, 701687, 701713, 701720, 701728, 701744, 701755, 701808, 701823.

Quantity recalled1,050 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0104-2026
FDA event ID: 97467
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class I
Status: Ongoing
Recall initiated: 20 Aug 2025
FDA classified: 10 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Aug 2025	Recall initiated by company
10 Oct 2025	Classified by FDA	+51 days
22 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Model Number U226, VISIONIST CRT-P EL

Where it was distributed

Worldwide

Questions about this recall

Is Model Number U226, Visionist Crt-p EL recalled?

Yes. Boston Scientific recalled Model Number U226, Visionist Crt-p EL on 20 Aug 2025. The recall is Class I and its status is Ongoing. Recall number Z-0104-2026.

Why was it recalled?

Which lots are affected?

GTIN 00802526559457, Serial numbers: 700333, 700335, 700342, 700344, 700346, 700347, 700352, 700364, 700372, 700386, 700388, 700390, 700391, 700425, 700426, 700427, 700428, 700429, 700437, 700448, 700455, 700460, 700461, 700464, 700490, 700498, 700500, 700520, 700538, 700539, 700570, 700587, 700591, 700638, 700653, 700665, 700676, 700693, 700700, 700702, 700704, 700705, 700707, 700708, 700711, 700718, 700720, 700722, 700735, 700736, 700755, 700759, 700765, 700768, 700774, 700782, 700790, 700794, 700796, 700809, 700817, 700830, 700870, 700874, 700879, 700881, 700882, 700883, 700887, 700889, 700903, 700905, 700908, 700911, 700917, 700925, 700935, 700940, 700950, 700951, 700959, 700968, 700970, 700978, 700980, 700984, 700988, 700990, 700991, 700994, 700997, 701005, 701008, 701017, 701019, 701023, 701032, 701038, 701048, 701071, 701083, 701091, 701096, 701097, 701100, 701108, 701116, 701117, 701122, 701127, 701136, 701140, 701141, 701142, 701146, 701147, 701148, 701151, 701153, 701154, 701161, 701165, 701166, 701167, 701174, 701178, 701181, 701182, 701183, 701187, 701192, 701197, 701199, 701201, 701203, 701207, 701212, 701217, 701240, 701242, 701247, 701249, 701252, 701255, 701256, 701318, 701320, 701321, 701330, 701334, 701335, 701342, 701349, 701356, 701425, 701427, 701439, 701440, 701446, 701447, 701448, 701462, 701490, 701510, 701511, 701517, 701525, 701528, 701529, 701532, 701537, 701538, 701539, 701543, 701547, 701550, 701551, 701556, 701559, 701562, 701563, 701564, 701589, 701590, 701597, 701603, 701607, 701631, 701643, 701647, 701649, 701661, 701662, 701664, 701685, 701686, 701690, 701691, 701696, 701703, 701709, 701714, 701715, 701722, 701723, 701727, 701729, 701732, 701735, 701736, 701741, 701745, 701750, 701756, 701758, 701768, 701769, 701771, 701772, 701778, 701783, 701789, 701790, 701799, 701803, 701807, 701817, 701818, 701826, 701827, 700890, 700907, 700928, 700929, 700936. GTIN 00802526559464, Serial numbers: 100006, 100009, 100011, 100012, 100013, 100014, 100016, 100017, 100018, 100019, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100032, 100034, 100035, 100038, 100039, 100042, 100044, 100045, 100046, 100048, 100049, 100050, 100052, 100053, 100054, 100055, 100058, 100059, 100061, 100062, 100063, 100066, 100067, 100068, 100069, 100070, 100073, 100075, 100076, 100077, 100081, 100087, 100089, 100092, 100094, 100095, 100096, 100098, 100100, 100101, 100102, 100105, 100107, 100108, 100109, 100111, 100112, 100113, 100116, 100117, 100118, 100120, 100123, 100124, 100126, 100127, 100128, 100129, 100132, 100133, 100134, 100135, 100136, 700002, 700003, 700004, 700006, 700007, 700008, 700010, 700011, 700012, 700013, 700014, 700015, 700018, 700019, 700020, 700021, 700023, 700024, 700025, 700026, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700042, 700044, 700045, 700048, 700050, 700051, 700052, 700053, 700054, 700056, 700057, 700058, 700059, 700060, 700061, 700063, 700065, 700066, 700067, 700068, 700071, 700072, 700074, 700075, 700076, 700077, 700081, 700082, 700083, 700084, 700087, 700088, 700089, 700090, 700091, 700092, 700093, 700094, 700095, 700096, 700098, 700099, 700101, 700102, 700103, 700106, 700107, 700108, 700111, 700114, 700118, 700120, 700121, 700122, 700124, 700125, 700126, 700132, 700135, 700137, 700139, 700140, 700141, 700142, 700143, 700145, 700146, 700147, 700149, 700151, 700153, 700154, 700155, 700156, 700159, 700163, 700164, 700167, 700168, 700169, 700170, 700171, 700172, 700183, 700184, 700186, 700187, 700191, 700192, 700193, 700194, 700199, 700201, 700207, 700209, 700210, 700211, 700212, 700213, 700214, 700215, 700216, 700218, 700220, 700225, 700226, 700227, 700229, 700230, 700231, 700237, 700239, 700240, 700241, 700245, 700246, 700247, 700249, 700264, 700265, 700267, 700268, 700269, 700270, 700275, 700276, 700277, 700280, 700286, 700287, 700288, 700289, 700291, 700292, 700293, 700296, 700298, 700301, 700304, 700306, 700309, 700311, 700312, 700313, 700314, 700316, 700321, 700326, 700327, 700328, 700329, 700331, 700340, 700343, 700357, 700363, 700375, 700376, 700378, 700379, 700380, 700382, 700393, 700394, 700395, 700397, 700400, 700401, 700402, 700404, 700405, 700406, 700411, 700413, 700415, 700417, 700419, 700421, 700423, 700433, 700435, 700439, 700442, 700446, 700449, 700453, 700454, 700456, 700457, 700466, 700467, 700470, 700471, 700473, 700474, 700476, 700477, 700478, 700479, 700480, 700482, 700485, 700487, 700492, 700493, 700494, 700495, 700496, 700499, 700502, 700507, 700508, 700509, 700510, 700517, 700521, 700526, 700527, 700528, 700530, 700534, 700536, 700537, 700542, 700546, 700548, 700551, 700553, 700555, 700556, 700557, 700558, 700559, 700560, 700561, 700563, 700564, 700566, 700567, 700574, 700575, 700576, 700577, 700579, 700580, 700581, 700582, 700584, 700585, 700588, 700590, 700593, 700594, 700595, 700596, 700597, 700599, 700603, 700604, 700605, 700610, 700611, 700612, 700613, 700615, 700616, 700617, 700618, 700619, 700620, 700622, 700623, 700625, 700627, 700629, 700630, 700640, 700654, 700656, 700659, 700660, 700667, 700670, 700672, 700673, 700678, 700679, 700682, 700687, 700689, 700695, 700697, 700709, 700724, 700725, 700737, 700739, 700767, 700780, 700811, 700812, 700824, 700827, 700828, 700829, 700834, 700836, 700838, 700845, 700855, 700858, 700862, 700865, 700868, 700869, 700875, 700877, 700894, 700897, 700900, 700904, 700910, 700916, 700921, 700923, 700924, 700926, 700931, 700938, 700945, 700949, 700957, 700958, 700973, 700976, 700977, 700981, 700982, 700983, 700985, 700986, 700987, 700992, 701000, 701006, 701011, 701015, 701031, 701033, 701037, 701040, 701045, 701068, 701073, 701074, 701076, 701077, 701081, 701082, 701086, 701087, 701090, 701098, 701099, 701101, 701112, 701113, 701115, 701120, 701124, 701128, 701133, 701149, 701150, 701156, 701157, 701158, 701159, 701162, 701163, 701164, 701168, 701170, 701173, 701175, 701177, 701179, 701186, 701188, 701193, 701195, 701200, 701202, 701204, 701206, 701210, 701211, 701213, 701216, 701221, 701222, 701225, 701228, 701229, 701231, 701232, 701236, 701261, 701262, 701264, 701265, 701266, 701267, 701268, 701270, 701275, 701277, 701278, 701279, 701280, 701283, 701284, 701287, 701288, 701291, 701292, 701294, 701296, 701297, 701299, 701300, 701301, 701304, 701305, 701307, 701308, 701310, 701315, 701329, 701333, 701340, 701347, 701351, 701359, 701361, 701363, 701364, 701367, 701374, 701375, 701376, 701387, 701389, 701395, 701402, 701404, 701405, 701407, 701409, 701410, 701411, 701413, 701416, 701422, 701428, 701430, 701431, 701432, 701436, 701444, 701454, 701456, 701460, 701464, 701466, 701469, 701471, 701483, 701497, 701500, 701501, 701502, 701504, 701506, 701507, 701509, 701512, 701513, 701514, 701515, 701518, 701522, 701524, 701527, 701533, 701540, 701541, 701544, 701546, 701548, 701549, 701553, 701557, 701565, 701566, 701567, 701569, 701572, 701575, 701577, 701578, 701579, 701580, 701581, 701583, 701585, 701586, 701588, 701593, 701594, 701595, 701596, 701598, 701599, 701600, 701602, 701610, 701611, 701613, 701614, 701615, 701618, 701619, 701620, 701621, 701624, 701627, 701628, 701629, 701634, 701637, 701638, 701644, 701645, 701650, 701653, 701654, 701655, 701658, 701659, 701660, 701665, 701666, 701667, 701668, 701669, 701670, 701671, 701674, 701676, 701677, 701678, 701679, 701681, 701683, 701695, 701697, 701698, 701699, 701700, 701701, 701706, 701710, 701711, 701718, 701719, 701724, 701725, 701726, 701734, 701737, 701746, 701749, 701754, 701759, 701761, 701763, 701765, 701767, 701770, 701773, 701774, 701775, 701776, 701777, 701779, 701780, 701785, 701787, 701788, 701791, 701796, 701801, 701804, 701805, 701809, 701812, 701820, 701821. GTIN 00802526577123, Serial numbers: 100074, 100085, 100106, 700079, 700109, 700110, 700123, 700219, 700222, 700232, 700266, 700278, 700279, 700282, 700290, 700300, 700302, 700305, 700310, 700323, 700325, 700366, 700458, 700503, 700543, 700608, 700651, 700662, 700688, 700692, 700694, 700764, 700798, 700805, 700810, 700833, 700837, 700839, 700840, 700848, 700852, 700854, 700856, 700857, 700863, 700867, 700896, 700898, 700934, 700955, 700995, 701095, 701103, 701205, 701208, 701209, 701282, 701285, 701289, 701293, 701302, 701314, 701420, 701426, 701434, 701474, 701487, 701493, 701498, 701499, 701503, 701508, 701520, 701526, 701531, 701535, 701558, 701560, 701573, 701574, 701606, 701625, 701640, 701672, 701682, 701687, 701713, 701720, 701728, 701744, 701755, 701808, 701823.

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS I	Enroute Transcarotid Neuroprotection System recalled	Boston Scientific	Other	Nationwide
26 Aug 2026Device	CLASS I	Enroute Transcarotid Neuroprotection System Plus recalled	Boston Scientific	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide