CLASS II ONGOING Device recall · Reported 4 May 2022 · FDA Enforcement Report

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO recalled

Boston Scientific is recalling SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101, distributed nationwide in the US. The recall was initiated on 24 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPN SO-1010, GTIN 00864661000157, Batch Numbers: 25512955, 25512956, 25608548, 25646105, 25652246, 25676663, 25676664, 25681783, 25814685, 25814686, 25814687, 25822800, 25822812, 25822814, 25822815, 25822818, 25846481, 26059500, 26199152, 26199153, 26199154, 26199155, 26223961, 26223962, 26223963, 26223964, 26223965, 26249663, 26296567, 26296568, 26330692, 26330693, 26330694, 26330695, 26360535, 26360536, 26392679, 26450673, 26450674, 26450675, 26479093, 26514195, 26514196, 26514197, 26514198, 26552142, 26552143, 26552144, 26552145, 26552146, 26552147, 26552148, 26552149, 26552150, 26559675, 26582245, 26582246, 26582247, 26582248, 26604083, 26604084, 26604085, 26620165, 26620166, 26747082, 26747083, 26747084, 26810389, 26810390, 26840623, 26840624, 26891606, 26891607, 26942179, 26943300, 26962856, 26962857, 27092550, 27092551, 27092552, 27123363, 27164903, 27164904, 27208217, 27224418, 27251110, 27251111, 27290123, 27290124, 27290125, 27290126, 27705892, 27705893, 27777685, 27777686, 27818531, 27818831, 27860308, 28189378, 28221394, 28221395, 28221396, 28221397, 28398571, 28398572, 28413030, 28535614; UPN SO-2101, GTIN 00864661000102, Batch Numbers: 25447885, 25449325, 25454386, 25454387, 25461459, 25495940, 25498279, 25498740, 25498741, 25498742, 25503112, 25503113, 25503114, 25503115, 25503116, 25506791, 25513909, 25513910, 25513911, 25513912, 25516002, 25516004, 25518766, 25518767, 25518769, 25518770, 25604214, 25604215, 25608549, 25630371, 25630372, 25630373, 25633109, 25638880, 25638881, 25638882, 25638883, 25640316, 25640317, 25646106, 25650375, 25650376, 25652248, 25652249, 25652250, 25660251, 25660252, 25661506, 25665261, 25665262, 25665263, 25681784, 25686490, 25686491, 25692043, 25698959, 25699200, 25699201, 25699202, 25706244, 25706245, 25707436, 25707437, 25712686, 25712687, 25712688, 25712689, 25720694, 25720695, 25720696, 25725090, 25743052, 25743053, 25743054, 25746319, 25746420, 25746421, 25746422, 25746423, 25748984, 25748985, 25748986, 25748987, 25752521, 25752522, 25752523, 25752524, 25773305, 25773306, 25775424, 25775425, 25780322, 25780323, 25829631, 25829632, 25829633, 25829634, 25829635, 25838013, 25838014, 25846482, 25846483, 25846484, 25846485, 25852659, 25852880, 25852881, 25852882, 25852883, 25861746, 25861747, 25876396, 25876397, 25876398, 25876399, 25876840, 25876841, 25878667, 25878668, 25878669, 25883155, 25883156, 25883157, 25883158, 25883159, 25889579, 25890040, 25890041, 25890042, 25891035, 25907181, 25907182, 25909720, 25909721, 25909722, 25909723, 25916278, 25916279, 25916440, 25916441, 25916442, 25916443, 25921966, 25921967, 25921968, 25921969, 25921970, 25934785, 25934786, 25934787, 25934788, 25934789, 25945186, 25945187, 25945188, 25945189, 25952097, 25952098, 25952099, 25963297, 25963298, 25963299, 25963440, 25970532, 25970533, 25988372, 25988373, 25988374, 25988375, 25997188, 26005315, 26005316, 26005317, 26005318, 26014544, 26014545, 26014546, 26028461, 26028462, 26028463, 26028464, 26028465, 26035128, 26035129, 26042542, 26042543, 26042544, 26042545, 26042546, 26042547, 26042548, 26058237, 26058238, 26058239, 26059080, 26059081, 26059501, 26060392, 26071663, 26071664, 26071671, 26071672, 26071673, 26071674, 26075962, 26075997, 26078689, 26078690, 26078691, 26078692, 26078693, 26088832, 26088833, 26088834, 26088835, 26088836, 26106496, 26106497, 26106498, 26106499, 26107243, 26107244, 26107245, 26107246, 26107247, 26111500, 26111501, 26111502, 26111503, 26111504, 26111505, 26121817, 26121818, 26121819, 26122100, 26128620, 26128621, 26128622, 26128623, 26137216, 26137217, 26170536, 26170537, 26172513, 26172514, 26172515, 26172516, 26172517, 26177019, 26177460, 26177461, 26178897, 26178898, 26184397, 26184398, 26184399, 26184580, 26184581, 26186561, 26186562, 26186563, 26186564, 26186565, 26187164, 26187165, 26191446, 26191447, 26191448, 26191449, 26191450, 26193736, 26193737, 26193738, 26209535, 26209536, 26209537, 26209538, 26212441, 26212442, 26212443, 26212444, 26216386, 26216387, 26216388, 26216389, 26216390, 26219745, 26219746, 26223179, 26223960, 26240334, 26240335, 26240336, 26240337, 26248777, 26248778, 26248779, 26248900, 26249466, 26249467, 26255000, 26255001, 26255002, 26255003, 26255004, 26257955, 26257956, 26257957, 26257958, 26264347, 26264348, 26264349, 26264350, 26264351, 26264352, 26268603, 26276556, 26276558, 26276559, 26287765, 26287766, 26287767, 26294565, 26301543, 26301544, 26301545, 26301546, 26302983, 26302984, 26308362, 26308363, 26308364, 26308365, 26308366, 26309943, 26316226, 26316227, 26316228, 26316229, 26325606, 26325607, 26360529, 26360530, 26360531, 26360532, 26390962, 26390963, 26390964, 26390965, 26390966, 26390967, 26479092, 26514199, 26514580, 26588906, 26588907, 26588908, 26588909, 26604086, 26604087, 26620161, 26620162, 26634757, 26634758, 26660269, 26736692, 26736693, 26736694, 26736695, 26736696, 26736697, 26747085, 26747086, 26754536, 26754537, 26774348, 26774349, 26774350, 26774351, 26774352, 26779764, 26780807, 26780808, 26780809, 26780810, 26789109, 26789110, 26789111, 26789112, 26789113, 26789114, 26793656, 26793657, 26812137, 26812138, 26812300, 26812301, 26812302, 26818264, 26818265, 26818266, 26818267, 26818268, 26825865, 26825866, 26825867, 26825868, 26825869, 26825875, 26826806, 26826807, 26826808, 26826809, 26839287, 26839288, 26839289, 26839290, 26841748, 26841749, 26841750, 26853559, 26853660, 26853661, 26853662, 26858288, 26858289, 26861588, 26861589, 26861590, 26861591, 26872638, 26872639, 26872940, 26872941, 26874784, 26880773, 26880774, 26893006, 26899183, 26899814, 26899815, 26906499, 26906601, 26908502, 26915827, 26915828, 26915829, 26915830, 26915831, 26929703, 26929704, 26929705, 26929706, 26929707, 26929708, 26943301, 26943302, 26943303, 26943304, 26946030, 26946031, 26946032, 26946033, 26946034, 26953304, 26953305, 26953306, 26953307, 26953308, 26962858, 26962859, 26975142, 26975143, 26975144, 26975145, 26975146, 26975147, 26977990, 26977991, 26977992, 26977993, 26984734, 26984735, 26984736, 26984737, 26984738, 27000738, 27000739, 27000920, 27000921, 27000922, 27010828, 27010829, 27012856, 27012857, 27024883, 27024884, 27024885, 27043543, 27043544, 27043545, 27043546, 27043547, 27054423, 27054424, 27054425, 27054426, 27054427, 27066782, 27066783, 27066784, 27066785, 27066786, 27068993, 27068994, 27068995, 27068996, 27068997, 27078868, 27078869, 27078870, 27078871, 27084715, 27084716, 27084717, 27084718, 27084719, 27092553, 27092554, 27092555, 27092556, 27100761, 27100762, 27100763, 27100764, 27100765, 27100766, 27107933, 27111856, 27208218, 27208219, 27221063, 27221064, 27231498, 27236459, 27236700, 27242448, 27242449, 27244886, 27244887, 27246025, 27246026, 27246027, 27251112, 27251113, 27252178, 27252179, 27257779, 27257800, 27260683, 27271944, 27271945, 27292531, 27292532, 27292533, 27292534, 27292535, 27413642, 27413643, 27413644, 27413645, 27413646, 27449092, 27449093, 27449095, 27449098, 27449100, 27449101, 27455961, 27455962, 27455963, 27455964, 27455965, 27469814, 27479346, 27479347, 27479348, 27479349, 27486742, 27486743, 27486745, 27505530, 27505531, 27505532, 27505533, 27599094, 27599096, 27602402, 27602404, 27602405, 27603120, 27652822, 27652823, 27652824, 27652825, 27655873, 27662657, 27662658, 27662659, 27663280, 27663281, 27679874, 27679876, 27679877, 27679879, 27743988, 27763343, 27763344, 27763345, 27763346, 27763347, 27763348, 27769335, 27769336, 27769337, 27793813, 27793814, 27793815, 27793816, 27806839, 27807080, 27807081, 27807082, 27807083, 27813807, 27813808, 27813809, 27819827, 27819828, 27848798, 27848799, 27849260, 27852324, 27852325, 27852326, 27860309, 27860310, 27863293, 27863294, 27868625, 27889555, 27889556, 27889557, 27889558, 27921327, 27921328, 27921329, 27921330, 27921441, 27941125, 27941126, 28030987, 28030988, 28030989, 28030990, 28030991, 28030992, 28030993, 28033235, 28033236, 28033237, 28033536, 28034352, 28034353, 28034354, 28034355, 28039068, 28039069, 28039070, 28039071, 28053880, 28053881, 28053882, 28060816, 28060817, 28062669, 28062670, 28062671, 28068730, 28068731, 28075079, 28075500, 28083772, 28083773, 28104421, 28110690, 28110691, 28110692, 28116632, 28116633, 28116639, 28116920, 28138215, 28138216, 28138217, 28138218, 28144107, 28144108, 28150892, 28150893, 28163398, 28163820, 28163821, 28163822, 28179664, 28179665, 28187744, 28187745, 28187746, 28187747, 28187748, 28187749, 28196188, 28196189, 28201559, 28237148, 28237149, 28237150, 28237151, 28237390, 28237391, 28237392, 28294715, 28294716, 28294717, 28306763, 28311109, 28311110, 28313987, 28313988, 28313989, 28323411, 28323412, 28323413, 28335610, 28335611, 28335612, 28350362, 28350363, 28350364, 28350365, 28358408, 28358409, 28389631, 28389632, 28389633, 28389634, 28398573, 28398574, 28398575, 28419101, 28432890, 28432891, 28446435, 28446436, 28446437, 28463387, 28463388, 28464793, 28499509, 28499510, 28499511, 28499512, 28536808, 28536809, 28549083, 28549084, 28549085, 28558906, 28558907, 28558908, 28565354, 28600712, 28600713, 28600714, 28600715, 28600716, 28600717, 28600718, 28608550, 28608551, 28608552, 28613671, 28613672, 28613673, 28613674, 28623413, 28623414, 28623415, 28661032, 28661033, 28661034, 28694688, 28694689, 28707783, 28707784, 28734765, 28734766, 28734767, 28734768, 28743894, 28766549, 28766550, 28766551, 28778877, 28778878, 28778879; UPN SO-3101, GTIN 00864661000164, Batch Numbers: 25985439, 26140617, 26140618, 26140619, 26141060, 26141061, 26141062, 26170538, 26249662, 26517605, 28377015; UPN SO-4101, GTIN 00864661000126, Batch Numbers: 25449321, 25450979, 25454390, 25731415, 25731416, 25731579, 25732220, 25765632, 25765633, 25765634, 25814682, 25814683, 25838015, 25838016, 25838017, 25838018, 25852884, 25980707, 25980708, 25980709, 25980710, 25980711, 26021050, 26021051, 26021052, 26021053, 26060390, 26060391, 26071456, 26071458, 26111508, 26111509, 26111510, 26111511, 26170539, 26199156, 26248901, 26248902, 26257959, 26258400, 26287768, 26287769, 26294566, 26294567, 26334369, 26334370, 26360533, 26360534, 26436689, 26436690, 26436691, 26436692, 26436693, 26436694, 26436695, 26436696, 26479094, 26559676, 26559677, 26559678, 26559679, 26565454, 26565455, 26565456, 26588911, 26588912, 26604088, 26604089, 26620163, 26620164, 26627125, 26627126, 26627127, 26627128, 26641185, 26641186, 26641188, 26644531, 26644714, 26751685, 26751686, 26751687, 26751688, 26751689, 27197339, 27197621, 27207235, 27231495, 27231496, 27231497, 27253522, 27258004, 27258005, 27268188, 27274046, 27274047, 27274048, 27274049, 27296389, 27296390, 27296391, 27358080, 27358081, 27360957, 27360958, 27360959, 27731084, 27731085, 27731086, 27743989, 27743990, 27777687, 27777688, 27818832, 27818833, 27854598, 27854599, 27854820, 27880084, 27880085, 28051253, 28059295, 28059296, 28062672, 28068732, 28074277, 28083774, 28103327, 28103328, 28103329, 28134238, 28134239, 28135200, 28135201, 28135202, 28135203, 28189379, 28189380, 28196192, 28202161, 28377016, 28377017, 28398576, 28398577, 28406228, 28514992, 28514993, 28535613, 28578840, 28656267, 28656268, 28656269, 28656270, 28708930, 28743895, 28743896, 28788166, 28788167, 28788172

Quantity recalled61,852 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-1002-2022
FDA event ID: 89862
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Feb 2022
FDA classified: 25 Apr 2022
Reported: 4 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Feb 2022	Recall initiated by company
25 Apr 2022	Classified by FDA	+60 days
4 May 2022	Published in enforcement report	+9 days

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

Reason for recall

Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

Product as listed by the FDA

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Is SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101 recalled?

Yes. Boston Scientific recalled SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101 on 24 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-1002-2022.

Why was it recalled?

Which lots are affected?

UPN SO-1010, GTIN 00864661000157, Batch Numbers: 25512955, 25512956, 25608548, 25646105, 25652246, 25676663, 25676664, 25681783, 25814685, 25814686, 25814687, 25822800, 25822812, 25822814, 25822815, 25822818, 25846481, 26059500, 26199152, 26199153, 26199154, 26199155, 26223961, 26223962, 26223963, 26223964, 26223965, 26249663, 26296567, 26296568, 26330692, 26330693, 26330694, 26330695, 26360535, 26360536, 26392679, 26450673, 26450674, 26450675, 26479093, 26514195, 26514196, 26514197, 26514198, 26552142, 26552143, 26552144, 26552145, 26552146, 26552147, 26552148, 26552149, 26552150, 26559675, 26582245, 26582246, 26582247, 26582248, 26604083, 26604084, 26604085, 26620165, 26620166, 26747082, 26747083, 26747084, 26810389, 26810390, 26840623, 26840624, 26891606, 26891607, 26942179, 26943300, 26962856, 26962857, 27092550, 27092551, 27092552, 27123363, 27164903, 27164904, 27208217, 27224418, 27251110, 27251111, 27290123, 27290124, 27290125, 27290126, 27705892, 27705893, 27777685, 27777686, 27818531, 27818831, 27860308, 28189378, 28221394, 28221395, 28221396, 28221397, 28398571, 28398572, 28413030, 28535614; UPN SO-2101, GTIN 00864661000102, Batch Numbers: 25447885, 25449325, 25454386, 25454387, 25461459, 25495940, 25498279, 25498740, 25498741, 25498742, 25503112, 25503113, 25503114, 25503115, 25503116, 25506791, 25513909, 25513910, 25513911, 25513912, 25516002, 25516004, 25518766, 25518767, 25518769, 25518770, 25604214, 25604215, 25608549, 25630371, 25630372, 25630373, 25633109, 25638880, 25638881, 25638882, 25638883, 25640316, 25640317, 25646106, 25650375, 25650376, 25652248, 25652249, 25652250, 25660251, 25660252, 25661506, 25665261, 25665262, 25665263, 25681784, 25686490, 25686491, 25692043, 25698959, 25699200, 25699201, 25699202, 25706244, 25706245, 25707436, 25707437, 25712686, 25712687, 25712688, 25712689, 25720694, 25720695, 25720696, 25725090, 25743052, 25743053, 25743054, 25746319, 25746420, 25746421, 25746422, 25746423, 25748984, 25748985, 25748986, 25748987, 25752521, 25752522, 25752523, 25752524, 25773305, 25773306, 25775424, 25775425, 25780322, 25780323, 25829631, 25829632, 25829633, 25829634, 25829635, 25838013, 25838014, 25846482, 25846483, 25846484, 25846485, 25852659, 25852880, 25852881, 25852882, 25852883, 25861746, 25861747, 25876396, 25876397, 25876398, 25876399, 25876840, 25876841, 25878667, 25878668, 25878669, 25883155, 25883156, 25883157, 25883158, 25883159, 25889579, 25890040, 25890041, 25890042, 25891035, 25907181, 25907182, 25909720, 25909721, 25909722, 25909723, 25916278, 25916279, 25916440, 25916441, 25916442, 25916443, 25921966, 25921967, 25921968, 25921969, 25921970, 25934785, 25934786, 25934787, 25934788, 25934789, 25945186, 25945187, 25945188, 25945189, 25952097, 25952098, 25952099, 25963297, 25963298, 25963299, 25963440, 25970532, 25970533, 25988372, 25988373, 25988374, 25988375, 25997188, 26005315, 26005316, 26005317, 26005318, 26014544, 26014545, 26014546, 26028461, 26028462, 26028463, 26028464, 26028465, 26035128, 26035129, 26042542, 26042543, 26042544, 26042545, 26042546, 26042547, 26042548, 26058237, 26058238, 26058239, 26059080, 26059081, 26059501, 26060392, 26071663, 26071664, 26071671, 26071672, 26071673, 26071674, 26075962, 26075997, 26078689, 26078690, 26078691, 26078692, 26078693, 26088832, 26088833, 26088834, 26088835, 26088836, 26106496, 26106497, 26106498, 26106499, 26107243, 26107244, 26107245, 26107246, 26107247, 26111500, 26111501, 26111502, 26111503, 26111504, 26111505, 26121817, 26121818, 26121819, 26122100, 26128620, 26128621, 26128622, 26128623, 26137216, 26137217, 26170536, 26170537, 26172513, 26172514, 26172515, 26172516, 26172517, 26177019, 26177460, 26177461, 26178897, 26178898, 26184397, 26184398, 26184399, 26184580, 26184581, 26186561, 26186562, 26186563, 26186564, 26186565, 26187164, 26187165, 26191446, 26191447, 26191448, 26191449, 26191450, 26193736, 26193737, 26193738, 26209535, 26209536, 26209537, 26209538, 26212441, 26212442, 26212443, 26212444, 26216386, 26216387, 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26780809, 26780810, 26789109, 26789110, 26789111, 26789112, 26789113, 26789114, 26793656, 26793657, 26812137, 26812138, 26812300, 26812301, 26812302, 26818264, 26818265, 26818266, 26818267, 26818268, 26825865, 26825866, 26825867, 26825868, 26825869, 26825875, 26826806, 26826807, 26826808, 26826809, 26839287, 26839288, 26839289, 26839290, 26841748, 26841749, 26841750, 26853559, 26853660, 26853661, 26853662, 26858288, 26858289, 26861588, 26861589, 26861590, 26861591, 26872638, 26872639, 26872940, 26872941, 26874784, 26880773, 26880774, 26893006, 26899183, 26899814, 26899815, 26906499, 26906601, 26908502, 26915827, 26915828, 26915829, 26915830, 26915831, 26929703, 26929704, 26929705, 26929706, 26929707, 26929708, 26943301, 26943302, 26943303, 26943304, 26946030, 26946031, 26946032, 26946033, 26946034, 26953304, 26953305, 26953306, 26953307, 26953308, 26962858, 26962859, 26975142, 26975143, 26975144, 26975145, 26975146, 26975147, 26977990, 26977991, 26977992, 26977993, 26984734, 26984735, 26984736, 26984737, 26984738, 27000738, 27000739, 27000920, 27000921, 27000922, 27010828, 27010829, 27012856, 27012857, 27024883, 27024884, 27024885, 27043543, 27043544, 27043545, 27043546, 27043547, 27054423, 27054424, 27054425, 27054426, 27054427, 27066782, 27066783, 27066784, 27066785, 27066786, 27068993, 27068994, 27068995, 27068996, 27068997, 27078868, 27078869, 27078870, 27078871, 27084715, 27084716, 27084717, 27084718, 27084719, 27092553, 27092554, 27092555, 27092556, 27100761, 27100762, 27100763, 27100764, 27100765, 27100766, 27107933, 27111856, 27208218, 27208219, 27221063, 27221064, 27231498, 27236459, 27236700, 27242448, 27242449, 27244886, 27244887, 27246025, 27246026, 27246027, 27251112, 27251113, 27252178, 27252179, 27257779, 27257800, 27260683, 27271944, 27271945, 27292531, 27292532, 27292533, 27292534, 27292535, 27413642, 27413643, 27413644, 27413645, 27413646, 27449092, 27449093, 27449095, 27449098, 27449100, 27449101, 27455961, 27455962, 27455963, 27455964, 27455965, 27469814, 27479346, 27479347, 27479348, 27479349, 27486742, 27486743, 27486745, 27505530, 27505531, 27505532, 27505533, 27599094, 27599096, 27602402, 27602404, 27602405, 27603120, 27652822, 27652823, 27652824, 27652825, 27655873, 27662657, 27662658, 27662659, 27663280, 27663281, 27679874, 27679876, 27679877, 27679879, 27743988, 27763343, 27763344, 27763345, 27763346, 27763347, 27763348, 27769335, 27769336, 27769337, 27793813, 27793814, 27793815, 27793816, 27806839, 27807080, 27807081, 27807082, 27807083, 27813807, 27813808, 27813809, 27819827, 27819828, 27848798, 27848799, 27849260, 27852324, 27852325, 27852326, 27860309, 27860310, 27863293, 27863294, 27868625, 27889555, 27889556, 27889557, 27889558, 27921327, 27921328, 27921329, 27921330, 27921441, 27941125, 27941126, 28030987, 28030988, 28030989, 28030990, 28030991, 28030992, 28030993, 28033235, 28033236, 28033237, 28033536, 28034352, 28034353, 28034354, 28034355, 28039068, 28039069, 28039070, 28039071, 28053880, 28053881, 28053882, 28060816, 28060817, 28062669, 28062670, 28062671, 28068730, 28068731, 28075079, 28075500, 28083772, 28083773, 28104421, 28110690, 28110691, 28110692, 28116632, 28116633, 28116639, 28116920, 28138215, 28138216, 28138217, 28138218, 28144107, 28144108, 28150892, 28150893, 28163398, 28163820, 28163821, 28163822, 28179664, 28179665, 28187744, 28187745, 28187746, 28187747, 28187748, 28187749, 28196188, 28196189, 28201559, 28237148, 28237149, 28237150, 28237151, 28237390, 28237391, 28237392, 28294715, 28294716, 28294717, 28306763, 28311109, 28311110, 28313987, 28313988, 28313989, 28323411, 28323412, 28323413, 28335610, 28335611, 28335612, 28350362, 28350363, 28350364, 28350365, 28358408, 28358409, 28389631, 28389632, 28389633, 28389634, 28398573, 28398574, 28398575, 28419101, 28432890, 28432891, 28446435, 28446436, 28446437, 28463387, 28463388, 28464793, 28499509, 28499510, 28499511, 28499512, 28536808, 28536809, 28549083, 28549084, 28549085, 28558906, 28558907, 28558908, 28565354, 28600712, 28600713, 28600714, 28600715, 28600716, 28600717, 28600718, 28608550, 28608551, 28608552, 28613671, 28613672, 28613673, 28613674, 28623413, 28623414, 28623415, 28661032, 28661033, 28661034, 28694688, 28694689, 28707783, 28707784, 28734765, 28734766, 28734767, 28734768, 28743894, 28766549, 28766550, 28766551, 28778877, 28778878, 28778879; UPN SO-3101, GTIN 00864661000164, Batch Numbers: 25985439, 26140617, 26140618, 26140619, 26141060, 26141061, 26141062, 26170538, 26249662, 26517605, 28377015; UPN SO-4101, GTIN 00864661000126, Batch Numbers: 25449321, 25450979, 25454390, 25731415, 25731416, 25731579, 25732220, 25765632, 25765633, 25765634, 25814682, 25814683, 25838015, 25838016, 25838017, 25838018, 25852884, 25980707, 25980708, 25980709, 25980710, 25980711, 26021050, 26021051, 26021052, 26021053, 26060390, 26060391, 26071456, 26071458, 26111508, 26111509, 26111510, 26111511, 26170539, 26199156, 26248901, 26248902, 26257959, 26258400, 26287768, 26287769, 26294566, 26294567, 26334369, 26334370, 26360533, 26360534, 26436689, 26436690, 26436691, 26436692, 26436693, 26436694, 26436695, 26436696, 26479094, 26559676, 26559677, 26559678, 26559679, 26565454, 26565455, 26565456, 26588911, 26588912, 26604088, 26604089, 26620163, 26620164, 26627125, 26627126, 26627127, 26627128, 26641185, 26641186, 26641188, 26644531, 26644714, 26751685, 26751686, 26751687, 26751688, 26751689, 27197339, 27197621, 27207235, 27231495, 27231496, 27231497, 27253522, 27258004, 27258005, 27268188, 27274046, 27274047, 27274048, 27274049, 27296389, 27296390, 27296391, 27358080, 27358081, 27360957, 27360958, 27360959, 27731084, 27731085, 27731086, 27743989, 27743990, 27777687, 27777688, 27818832, 27818833, 27854598, 27854599, 27854820, 27880084, 27880085, 28051253, 28059295, 28059296, 28062672, 28068732, 28074277, 28083774, 28103327, 28103328, 28103329, 28134238, 28134239, 28135200, 28135201, 28135202, 28135203, 28189379, 28189380, 28196192, 28202161, 28377016, 28377017, 28398576, 28398577, 28406228, 28514992, 28514993, 28535613, 28578840, 28656267, 28656268, 28656269, 28656270, 28708930, 28743895, 28743896, 28788166, 28788167, 28788172

Where was it sold?

Worldwide - US Nationwide distribution.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

More recalls from Boston Scientific

All 626

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