Recalls affecting California

FDA has not published a risk classification for this recall yet.

Recall #:

86419

Lot/product code:

Model 1600517 / Catalog number 1600517-001 Serial Numbers: 18F0017 18F0030 18G0003 18G0018 18G0019 18G0020 18G0021 18G0025 18H0016 18H0017 18H0018 18H0019 18H0026 18H0027 18I0003 18I0004 18I0005 18I0006 18I0018 18I0022 18I0023 18I0024 18I0025 18I0026 18I0027 18I0028 18I0029 18I0030 18J0001 18J0002 18J0003 18J0004 18J0005 18J0009 18J0010 18J0011 18J0012 18J0013 18J0014 18J0015 18J0016 18J0017 18J0018 18J0019 18J0020 18J0021 18J0022 18J0023 18J0024 18J0025 18J0026 18J0037 18J0038 18J0039 18J0040 18J0041 18L0012 18L0014 18L0017 18L0018 18L0019 18L0020 18L0021 18L0023 19B0021 19B0022 19B0023 19B0024 19B0025 19B0028 19B0029 19B0030 19B0038 19B0041 19B0042 19B0043 19B0044 19B0051 19B0052 19B0053 19B0054 19B0055 19B0056 19B0058 19B0059 19E0004 19E0005 19E0008 19E0009 19E0011 19E0012 19E0013 19E0014 19E0015 19E0016 19E0017 19E0028 19E0029 19E0030 19E0035 19E0037 19E0047 19E0048 19E0053 19E0054 19E0055 19E0056 19E0057 19E0058 19E0060 19E0063 19E0064 19E0068 19E0069 16A0015 16A0016 16G0024 16I0007 16I0026 16I0027 16I0028 16I0029 16K0027 17A0009 17B0008 17B0009 17B0010 17B0011 17B0012 17B0013 17B0039 17B0040 17B0041 17B0049 17B0050 17C0012 17C0013 17E0033 17G0004 17G0024 17G0025 19E0006 19E0007 19E0010

Recalling firm:

Bien-Air Surgery Sa

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0038-2021

Lot/product code:

Lot #: 37009, Exp. 02/10/2021

Recalling firm:

Genesis Partnership Company SA

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0039-2021

Lot/product code:

Lot #: 37009, Exp. 02/10/2021

Recalling firm:

Genesis Partnership Company SA

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0037-2021

Lot/product code:

Lot #: 072120, Exp. 01/21/2022

Recalling firm:

Genesis Partnership Company SA

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0040-2021

Lot/product code:

Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21

Recalling firm:

Genesis Partnership Company SA

FDA has not published a risk classification for this recall yet.

Recall #:

86537

Lot/product code:

All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

93192

Lot/product code:

UDI-DI: 00849436000068, Serial Numbers: WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377, WF21378, WF21158, WF21391, WF21165, WF21166, WF21168, WF21169, WF21170, WF21172, WF21173, WF21174, WF21175, WF21176, WF21177, WF21178, WF21179, WF21182, WF21183, WF21184, WF21185, WF21186, WF21187, WF21188, WF21189, WF21190, WF21192, WF21193, WF21194, WF21195, WF21196, WF21197, WF21198, WF21199, WF21200, WF21201, WF21202, WF21203, WF21204, WF21205, WF21206, WF21207, WF21208, WF21209, WF21210, WF21211, WF21212, WF21213, WF21214, WF21215, WF21217, WF21218, WF21219, WF21220, WF21221, WF21222, WF21223, WF21224, WF21225, WF21226, WF21227, WF21228, WF21229, WF21230, WF21231, WF21232, WF21233, WF21234, WF21235, WF21236, WF21237, WF21238, WF21239, WF21240, WF21241, WF21242, WF21243, WF21244, WF21245, WF21246, WF21247, WF21248, WF21249, WF21250, WF21251, WF21252, WF21253, WF21254, WF21255, WF21256, WF21257, WF21258, WF21259, WF21260, WF21261, WF21262, WF21263, WF21264, WF21265, WF21266, WF21267, WF21268, WF21269, WF21270, WF21271, WF21272, WF21273, WF21274, WF21275, WF21276, WF21277, WF21278, WF21279, WF21280, WF21281, WF21282, WF21283, WF21284, WF21285, WF21286, WF21287, WF21288, WF21289, WF21290, WF21291, WF21292, WF21293, WF21294, WF21295, WF21296, WF21297, WF21298, WF21299, WF21300, WF21301, WF21302, WF21303, WF21304, WF21305, WF21306, WF21307, WF21308, WF21309, WF21310, WF21311, WF21312, WF21313, WF21314, WF21315, WF21316, WF21317, WF21318, WF21319, WF21320, WF21321, WF21322, WF21323, WF21324, WF21325, WF21326, WF21327, WF21328, WF21329, WF21330, WF21331, WF21332, WF21333, WF21334, WF21335, WF21336, WF21337, WF21338, WF21339, WF21340, WF21341, WF21342, WF21343, WF21344, WF21345, WF21346, WF21347, WF21348, WF21349, WF21350, WF21351, WF21352, WF21353, WF21354, WF21355, WF21356, WF21357, WF21358, WF21359, WF21360, WF21361, WF21362, WF21363, WF21364, WF21365, WF21366, WF21367, WF21368, WF21369, WF21370

Recalling firm:

Percussionaire Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

86476

Lot/product code:

Hurricane RX Dilation Balloon 4 mm 2 cm UPN/REF # M00545890 GTIN # 08714729283805 Lot/Batch # 25509445, 25536219, 25612668, 25649812, 25704208 EXP Date Range 04/13/2022 - 06/13/2022  Hurricane RX Dilation Balloon 4 mm 4 cm UPN/REF # M00545900 GTIN # 08714729283812 Lot/Batch #  25326198, 25344165, 25344168, 25366542, 25366543, 25379240, 25379241, 25392546, 25447687, 25447688, 25447689, 25447690, 25447691, 25447692, 25453103, 25453105, 25453108, 25466435, 25468596, 25468597, 25471588, 25479171, 25479176, 25479177, 25479178, 25479521, 25481983, 25481984, 25481985, 25481986, 25497466, 25497467, 25497468, 25506678, 25509440, 25509446, 25509447, 25509450, 25518274, 25518305, 25518314, 25533944, 25536416, 25536680, 25536860, 25543967, 25543969, 25571363, 25575934, 25575935, 25576717, 25576718, 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771765 EXP Date Range 02/07/2022 - 06/27/2022  Hurricane RX Dilation Balloon 6 mm 2 cm UPN/REF # M00545910 GTIN #08714729283829 Lot/Batch # 25456946, 25497472, 25571369, 25623385, 25678822, 25739151 EXP Date Range 03/22/2022 - 06/20/2022  Hurricane RX Dilation Balloon 6 mm 4 cm UPN/REF # M00545920 GTIN # 08714729283836 Lot/Batch # 25305803, 25326193, 25326194, 25326195, 25326199, 25334817, 25334818, 25366544, 25366545, 25366546, 25366547, 25392549, 25392551, 25392553, 25392554, 25392555, 25397943, 25397944, 25447697, 25447698, 25453106, 25453109, 25461680, 25466436, 25468598, 25472425, 25475235, 25475236, 25479172, 25479173, 25479179, 25481987, 25481988, 25481989, 25481990, 25481991, 25497469, 25497470, 25497473, 25497474, 25497475, 25509412, 25509413, 25509414, 25509451, 25509452, 25509453, 25518276, 25518306, 25518307, 25518315, 25518316, 25536681, 25536739, 25536740, 25543970, 25543971, 25543972, 25543973, 25571370, 25571373, 25576770, 25576771, 25576772, 25576773, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773 EXP Date Range 02/02/2022 - 06/27/2022  Hurricane RX Dilation Balloon 8 mm 2 cm UPN/REF # M00545930 GTIN # 08714729283843 Lot/Batch # 25509441, 25536741, 25644951, 25649190, 25650286, 25651334, 25654287 EXP Date Range 04/13/2022 - 05/31/2022  Hurricane RX Dilation Balloon 8 mm 4 cm UPN/REF # M00545940 GTIN # 08714729283850 Lot/Batch # 25317077, 25326196, 25326220, 25326221, 25326222, 25334819, 25344169, 25366548, 25366549, 25392556, 25392557, 25397079, 25447693, 25447694, 25453104, 25453107, 25453110, 25466437, 25468599, 25471589, 25471590, 25475234, 25479174, 25479175, 25479520, 25479580, 25481992, 25497051, 25497052, 25502738, 25509415, 25509416, 25509417, 25509418, 25509419, 25509442, 25509448, 25509454, 25509546, 25518277, 25518278, 25518317, 25518318, 25536682, 25536742, 25536743, 25543975, 25543976, 25543977, 25543978, 25543979, 25544020, 25571371, 25571374, 25596599, 25602458, 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801 EXP Date Range 02/04/2022 - 06/30/2022  Hurricane Rx Dilation Balloon 10 mm 2 cm UPN/REF # M00545950 GTIN # 08714729283867 Lot/Batch # 25471587, 25571372, 25588303, 25673064 EXP Date Range 03/28/2022 - 06/06/2022  Hurricane RX Dilation Balloon 10 mm 4 cm UPN/REF # M00545960 GTIN # 08714729283874 Lot/Batch # 25334980, 25344170, 25344171, 25366550, 25378999, 25397945, 25397950, 25447685, 25447695, 25447696, 25461681, 25464817, 25466438, 25471591, 25471592, 25484487, 25493901, 25497471, 25497476, 25509443, 25509444, 25509449, 25518279, 25518308, 25518309, 25536683, 25544022, 25544023, 25544024, 25544025, 25571375, 25602323, 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170 EXP Date 02/08/2022 - 06/20/2022

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

86531

Lot/product code:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86531

Lot/product code:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86531

Lot/product code:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86531

Lot/product code:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86531

Lot/product code:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86412

Lot/product code:

Model # 360-010-001 (A Li-Gator) lot codes: I8250 I8251 I8252 I8820 I8821 I8822 I8823 I8824 I8825 I9571-A I9572-A I9573-A I9716-A I9717-A I9718-A I9719-A J0113-A J0114-A J0115-A J0225-A J0227-A J0228-A J0229-A J0230-A J0231-A J0240-A J0243-A J0287-A

Recalling firm:

Genicon, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86531

Lot/product code:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86548

Lot/product code:

Lot 6487800  Serial numbers  95160 95283 95284 95285 95286 95287 95288 95289 95290 95291 95292 95293 95294 95295 95296 95297 95363 95364 95365 95366 95367 95368 95369 95370 95371 95372 95373 95374 95431 95432 95433 95374 95435 95436 95437 95438 95439 95440 95441 95442 95455 95456 95457 95458 95459 95460 95461 95462 95463 95464 95465 95466 95467 95468 95469 95470 95471 95472 95473 95474 95475 95476 95477 95478 95880 95881 95882 95883 95884 95885 95886 95887 95888 95889 95890 95891 95892 95893 95894 95895 95896 95897 95898 95899 95900 95901 95902 95903 95904 95905 95906 95907 95908 95909 95910 95911 95912 95913 95914 95915 95916 95917 95918 95919 95920 95921 95922 95923 95924 95925 95926 95927 95928 95929 95930 95931 95932 95933 95934 95935 95946 95947 96018 96019 96020 96021 96022 96023 96024 96025 96026 96027 96028 96029 96050 96051 96052 96053 96054 96055 96056 96057 96058 96059 96060 96061 96062 96063 96064 96065 96066 96067 96068 96069 96070 96071 96072 96073 96145 96146 96147 96148 96149 96150 96151 96152 96153 96154 96155 96156 96157 96158 96159 96160 96161 96162 96163 96164 96165 96166 96167 96168 96169 96170 96171 96172 96173 96174 96796 96797 96798 96799 96800 96801 96802 96803 96804 96885 96886 96887 96888 96889 96890 96891 96892 96893 96894 96895 96896 96897 96898 96899 96900 96901 96902 96903 96904 96905 96906 96907 96908 96909 96910 96911 96912 96913 96914 96915 96916 96917 96918 96919 96920 97045 97046 97047 97048 97049 97050 97051 97052 97053 97054 97055 97056 97057 97058 97059 97060 97061 97062 97063 97064 97065 97066 97067 97068 97069 97070 97071 97072 97073 97074 97075 97076 97077 97078 97079 97080 97149 97150 97151 97152 97153 97154 97155 97156 97157 97158 97159 97160 97161 97162 97163 97164 97165 97166 97167 97168 97169 97170 97171 97172 97173 97174 97175 97176 97177 97178 97179 97180 97181 97182 97183 97184 97185 97186 97187 97188 97189 97190 97191 97192 97193 97194 97195 97196 97197 97198 97199 97200 97201 97202 97203 97204 97205 97206 97207 97208 97209 97210 97211 97212 97213 97214 97215 97216 97217 97218 97219 97220 97519 97520 97521 97522 97523 97524 97525 97526 97527 97528 97529 97530 97531 97532 97533 97534 97535 97536 97537 97538 97539 97540 97541 97542 97543 97544 97545 97546 97547 97548 97549 97550 97551 97552 97553 97554 97555 97556 97557 97558 97559 97560 97561 97562 97563 97564 97565 97566 97567 97568 97569 97570 97571 97572 97573 97574 97575 97576 97577 97578 97579 97580 97581 97582 98318 98319 98321 98322 98323 98324 98325 98326 98327 98328 98329 98330 98331 98332 98333 98334 98335 98336 98337 98338 98339 98340 98341 98342 98343 98344

Recalling firm:

Getinge Group Logistics America, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86531

Lot/product code:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86575

Lot/product code:

All lots of products manufactured in the below timespan: July 1, 2015 and July 20, 2019

Recalling firm:

Cardinal Health 200, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86504

Lot/product code:

All lots UDI: (01)00630414595580(10)201115(17)20210201 (01)00630414595580(10)201207(17)20210601

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86575

Lot/product code:

All lots of products manufactured in the below timespan: July 1, 2015 and July 20, 2019

Recalling firm:

Cardinal Health 200, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86504

Lot/product code:

All lots UDI: (01)00630414558073(10)501874(17)20201128 (01)00630414558073(10)514594(17)20210221 (01)00630414558073(10)528971(17)20210630

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86562

Lot/product code:

UPNs 72404310  72404280 72404281 72404282 72404282-10 72404283 72404283-12 72404284 72404284-14 72404285 72404286 72404287 72404288 72404289  72404300 72404301 72404302 72404302-10 72404303 72404303-12 72404305 72404306 72404307 72404308  72404209  72404260 72404261 72404262 72404263 72404264 72404265 72404266 72404267 72404268 72404269  72404230 72404231 72404232 72404232-10 72404233 72404233-12 72404234 72404234-14 72404235 72404236 72404237 72404238 72404239  72404250 72404251 72404252 72404252-10 72404253 72404253-12 72404255 72404256 72404257 72404258  To determine if a UPN/serial number is impacted, visit: www.bostonscientific.com/lookup

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

86597

Lot/product code:

All lots of the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress are affected. Exp. Date: 5 years from date of manufacturing  EasyClip and EasyClip Xpress staples are available in a variety of sizes identified by product and catalog numbers. See below:  Product Number Product Description  EZ15-12-12 Osteosynthesis Compression Staple EasyClip 15x12x12mm EZ15-15-15 Osteosynthesis Compression Staple EasyClip 15x15x15mm  EZ18-12-12 Osteosynthesis Compression Staple EasyClip 18x12x12mm EZ18-15-13 Osteosynthesis Compression Staple EasyClip 18x15x13mm  EZ18-14-14 Osteosynthesis Compression Staple EasyClip 18x14x14mm EZ18-17-15 Osteosynthesis Compression Staple EasyClip 18x17x15mm  EZ18-19-17 Osteosynthesis Compression Staple EasyClip 18x19x17mm EZ20-16-16 Osteosynthesis Compression Staple EasyClip 20x16x16mm EZ20-20-20 Osteosynthesis Compression Staple EasyClip 20x20x20mm EZ25-22-22 Osteosynthesis Compression Staple EasyClip 25x22x22mm EZB10-15-13 Osteosynthesis Compression Staple EasyClip 10x15x13mm EZB10-17-15 Osteosynthesis Compression Staple EasyClip 10x17x15mm EZB10-19-16 Osteosynthesis Compression Staple EasyClip 10x19x16mm EZB10-20-17 Osteosynthesis Compression Staple EasyClip 10x20x17mm EZB12-15-13 Osteosynthesis Compression Staple EasyClip 12x15x13mm EZB10-22-20 Osteosynthesis Compression Staple EasyClip 10x22x20mm  EZB12-17-15 Osteosynthesis Compression Staple EasyClip 12x17x15mm EZB12-19-16 Osteosynthesis Compression Staple EasyClip 12x19x16mm  EZM08-08-08 Osteosynthesis Compression Staple EasyClip 8x8x8mm EZM10-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-14-14 Osteosynthesis Compression Staple EasyClip 12x14x14mm EZM12-16-16 Osteosynthesis Compression Staple EasyClip 12x16x16mm   Catalog # Product EZBXP10-15-13 EasyClip Xpress 10x15x13 EZBXP12-15-13 EasyClip Xpress 12x15x13  EZMXP08-08-08 EasyClip Xpress 08x08x08  EZMXP10-10-10 EasyClip Xpress 10x10x10 EZMXP12-10-10 EasyClip Xpress 12x10x10 EZXP15-12-12 EasyClip Xpress 15x12x12  EZXP15-15-15 EasyClip Xpress 15x15x15  EZXP18-14-14 EasyClip Xpress 18x14x14 EZXP18-17-15 EasyClip Xpress 18x17x15 EZXP18-19-17 EasyClip Xpress 18x19x17 EZXP20-16-16 EasyClip Xpress 20x16x16 EZXP20-20-20 EasyClip Xpress 20x20x20 EZXP25-22-22 EasyClip Xpress 25x22x22

Recalling firm:

Stryker GmbH

FDA has not published a risk classification for this recall yet.

Recall #:

86572

Lot/product code:

Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615

Recalling firm:

Merz North America, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86516

Lot/product code:

Lot Numbers: P826, P815, P796, P776

Recalling firm:

Epitope Diagnostics, Inc.