Use caution Medical device recall · FDA · Published February 24, 2022

Boston Scientific recalls SpaceOAR System for possible embolism risk during prostate

Boston Scientific recalls SpaceOAR System models SO-1010, SO-2101, SO-3101, and SO-4101 due to possible embolism from hydrogel misplacement during prostate cancer radiotherapy. Updated instructions help verify correct placement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1002-2022Medical device Boston Scientific ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling specific versions of their SpaceOAR System for temporary prostate cancer treatment. The recall is because there's a risk of embolism (blood clots) if the hydrogel material isn't placed correctly during surgery. The company has updated instructions to help doctors check proper placement. Read more at govinfonow.com/recall/61040-boston-scientific-recalls-spaceoar-system-for-possible-embolism-risk-during.

Source Summary by GovInfoNow · govinfonow.com/recall/61040-boston-scientific-recalls-spaceoar-system-for-possible-embolism-risk-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1002-2022

Cite this page

“Boston Scientific recalls SpaceOAR System for possible embolism risk during prostate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61040-boston-scientific-recalls-spaceoar-system-for-possible-embolism-risk-during. Based on FDA recall #Z-1002-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1002-2022%22&limit=1).

The FDA announced on Feb. 24, 2022, that Boston Scientific Corporation is recalling the SpaceOAR System due to the risk of embolism from hydrogel misplacement. The agency said users should follow updated instructions to verify correct placement. This Class II recall affects 61,852 units distributed worldwide.

How to tell if you have it

SpaceOAR System, UPN SO-1010, GTIN 00864661000157
SpaceOAR System, UPN SO-2101, GTIN 00864661000102
SpaceOAR System, UPN SO-3101, GTIN 00864661000164
SpaceOAR System, UPN SO-4101, GTIN 00864661000126

The hazard

According to the FDA, embolism is a possible adverse event associated with hydrogel misplacements. The updated Instructions for Use (IFU) provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since 2017-06-01. Recent recalls include the Imager II Angiographic Catheters Recall for tip fracture risk (2026-08-24) and the LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts (2026-08-06). Other recent recalls of similar products include the Intracept Access Instruments Recall for risk of sterility breach (2026-04-22), the Pack Angiography Kits recall for risk of blood clots from particulate (2026-05-13), and the SC-4318 Clik X Anchor Recall for sterile anchor lack of sterility assurance (2026-04-29).

How to tell if you have this one

Check for the model numbers SO-1010, SO-2101, SO-3101, or SO-4101 with the listed batch numbers and GTIN codes. These products were used to temporarily position the rectal wall away from the prostate during radiotherapy.

Brand
Boston Scientific
Product
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1002-2022	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.; 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, 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	61,852 units
Z-1003-2022	SpaceOAR Vue System, UPN SV-1010 and SV-2101. 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.; UPN SV-1010, GTIN 00850009803009, Batch Numbers: 26383209, 26383210, 26517604, 26861584, 26861585, 26891612, 26891613, 27083784, 27190242, 27210560, 27257801, 27257802, 27455966, 27455967, 27496959, 27497140, 27670956, 27708041, 27708042, 27708043, 27930863, 27930864, 27941129, 27941130, 27949315, 28094077, 28247077, 28247078, 28358778, 28377018, 28377019, 28464794, 28464795, 28496461, 28496462, 28578758, 28578759, 28608231, 28608232; UPN SV-2101, GTIN 00864661000140, Batch Numbers: 26345481, 26376961, 26376962, 26376963, 26376964, 26380456, 26380457, 26384055, 26384056, 26408849, 26485974, 26485975, 26485977, 26486586, 26486587, 26486588, 26493461, 26517606, 26517607, 26529719, 26567283, 26567284, 26567285, 26567286, 26567287, 26574373, 26574374, 26574378, 26574379, 26574441, 26611593, 26611594, 26611595, 26652286, 26652287, 26691824, 26691826, 26691827, 26691828, 26705563, 26705564, 26705565, 26705566, 26728564, 26728565, 26743769, 26743770, 26743771, 26743772, 26745057, 26770161, 26770162, 26770163, 26770164, 26770165, 26861586, 26880769, 26880770, 26880771, 26880772, 26898042, 26898043, 26898044, 26898045, 26899812, 26899813, 26906603, 26906604, 26929712, 26929713, 26929714, 26929715, 26929716, 26929717, 26929719, 26929860, 26929861, 26957514, 26957515, 26957516, 26957517, 26969537, 26969538, 26969539, 26970440, 26970441, 26970442, 27010832, 27040235, 27040236, 27060422, 27060423, 27060424, 27060425, 27060426, 27078872, 27078873, 27084457, 27084458, 27084459, 27084960, 27100768, 27100769, 27100770, 27123402, 27123404, 27140485, 27140486, 27163487, 27163488, 27180605, 27190243, 27190244, 27190245, 27190686, 27193837, 27193838, 27193839, 27194460, 27194461, 27197622, 27197623, 27214381, 27214382, 27214383, 27224419, 27257804, 27257805, 27259062, 27259063, 27259064, 27259065, 27268186, 27268187, 27283462, 27283463, 27283464, 27283465, 27283466, 27317224, 27317225, 27317226, 27329273, 27329274, 27329275, 27358004, 27358005, 27361380, 27361381, 27382203, 27382204, 27416003, 27416004, 27416005, 27416006, 27416007, 27444898, 27444899, 27445360, 27447905, 27469811, 27469812, 27469813, 27475230, 27496957, 27496958, 27512052, 27512053, 27512054, 27512055, 27517685, 27518868, 27518869, 27528492, 27531152, 27531153, 27531154, 27531155, 27531156, 27531157, 27601494, 27601495, 27657444, 27657445, 27657446, 27670942, 27670945, 27670946, 27670949, 27705891, 27720117, 27720118, 27720119, 27745215, 27745216, 27756475, 27769338, 27769339, 27769860, 27769861, 27769862, 27769863, 27797083, 27797084, 27797085, 27797086, 27797087, 28094078, 28094079, 28094320, 28103330, 28104177, 28104178, 28104179, 28104420, 28110684, 28110685, 28110686, 28110687, 28116634, 28116635, 28138219, 28138440, 28146630, 28146631, 28169753, 28169754, 28169755, 28179669, 28179670, 28179671, 28202160, 28237387, 28237388, 28237389, 28247079, 28247160, 28247161, 28247162, 28247269, 28247270, 28247271, 28247272, 28254386, 28254387, 28254388, 28265943, 28265944, 28265945, 28265946, 28265947, 28272556, 28272557, 28272558, 28272559, 28272560, 28287355, 28287356, 28294718, 28294719, 28311111, 28311112, 28323414, 28323415, 28323416, 28323417, 28335613, 28335614, 28350366, 28350367, 28350368, 28350369, 28364006, 28364007, 28364008, 28371227, 28371228, 28371229, 28389635, 28389636, 28412353, 28419102, 28419103, 28432892, 28432893, 28473289, 28473290, 28493777, 28493778, 28499505, 28499506, 28499507, 28555843, 28565355, 28565356, 28565357, 28587389, 28587390, 28587391, 28587392, 28587393, 28587394, 28605867, 28606252, 28611099, 28612440, 28612441, 28612442, 28613189, 28635760, 28635761, 28635762, 28635763, 28654059, 28654440, 28654441, 28663263, 28663264, 28663265, 28668946, 28668947, 28668948, 28683114, 28683115, 28686271, 28686272, 28686273, 28694687, 28707785, 28709642, 28709643, 28714572, 28723144, 28734763, 28734764, 28758266, 28766992, 28766993, 28766994, 28766995, 28766996, 28811555, 28811556, 28811558, 28811560, 28819972, 28819973, 28821692, 28821693, 28822526, 28822527, 28828281, 28828282, 28836638, 28836639, 28838125	23,368 units

Based on the official FDA remedy

What to do — step by step

Check Product Model
Identify if your SpaceOAR System has model numbers SO-1010, SO-2101, SO-3101, or SO-4101 with the listed batch numbers.
Verify Placement
If you have the recalled model, follow the updated instructions to check hydrogel placement before and after treatment.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 24, 2022Firm started the recall
Apr 25, 2022FDA classified it Class II
May 4, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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More Boston Scientific recalls

Link to this recall

<a href="https://govinfonow.com/recall/61040-boston-scientific-recalls-spaceoar-system-for-possible-embolism-risk-during">Boston Scientific recalls SpaceOAR System for possible embolism risk during prostate (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1002-2022 (February 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1002-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.