Recalls affecting Puerto Rico

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 #:

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 #:

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 #:

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 #:

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 #:

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

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

Recall #:

D-0057-2021

Lot/product code:

a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021

Recalling firm:

Denton Pharma, Inc.

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

Recall #:

D-0056-2021

Lot/product code:

N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021

Recalling firm:

Denton Pharma, Inc.

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

Recall #:

86643

Lot/product code:

serial Numbers: 35B1300004 35B1300010 35B1300019 35B1300021 35B1300022 35B1300025 35B1300036 35B1300037 35B1300045 35B1300046 35B1300013 35B1300041 35B1300006 35B1300008 35B1300009 35B1300027 35B1300051 35B1300016 35B1300042 35B1300005 35B1300026 35B1300031 35B1300001 35B1300040 35B1300050 35B1300020 35B1300033 35B1300030 35B1300044 35B1300011 35B1300048 35B1300035 35B1300002 35B1300029 35B1300038 35B1300014 35B1300017 35B1300003 35B1300015 35B1400001 35B1300018 35B1300034 35B1300007 35B1300032 35B1300043 35B1400005 35B1400010 35B1400013 35B1400020 35B1400024 35B1400009 35B1400028 35B1400017 35B1400025 35B1400023 35B1400011 35B1400021 35B1400032 35B1400033 35B1400034 35B1400040 35B1400003 35B1400026 35B1400030 35B1400035 35B1400044 35B1400048 35B1400055 35B1400056 35B1400059 35B1400060 35B1400061 35B1400063 35B1400049 35B1400068 35B1400069 35B1400050 35B1400062 35B1400064 35B1400072 35B1400007 35B1400015 35B1400058 35B1400077 35B1400083 35B1400057 35B1400041 35B1400066 35B1400070 35B1400087 35B1400088 35B1400092 35B1400074 35B1400091 35B1400039 35B1400071 35B1400075 35B1400012 35B1400042 35B1400053 35B1400065 35B1400079 35B1400080 35B1400095 35B1400073 35B1400082 35B1400038 35B1400036 35B1400097 35B1400101 35B1400104 35B1400067 35B1400047 35B1400006 35B1400103 35B1400110 35B1400112 35B1400113 35B1400116 35B1400111 35B1400108 35B1400109 35B1400098 35B1400081 35B1400096 35B1400022 35B1400105 35B1400119 35B1400122 35B1400123 35B1400124 35B1400126 35B1400100 35B1400129 35B1400130 35B1400132 35B1400137 35B1400134 35B1400131 35B1400135 35B1400115 35B1400127 35B1400027 35B1400084 35B1400138 35B1400093 35B1400133 35B1400141 35B1400149 35B1400142 35B1400145 35B1400147 35B1400150 35B1400153 35B1400051 35B1400136 35B1400152 35B1400139 35B1400037 35B1400159 35B1400078 35B1400089 35B1400114 35B1400117 35B1400120 35B1400140 35B1400143 35B1400151 35B1400155 35B1400157 35B1400158 35B1400172 35B1400164 35B1400154 35B1400161 35B1400162 35B1400018 35B1400160 35B1400174 35B1400176 35B1400179 35B1400004 35B1400156 35B1400198 35B1400191 35B1400197 35B1400099 35B1400165 35B1400169 35B1400180 35B1400217 35B1400182 35B1400170 35B1400148 35B1400189 35B1400194 35B1400106 35B1400118 35B1400166 35B1400171 35B1400185 35B1400188 35B1400192 35B1400199 35B1400210 35B1400228 35B1400203 35B1400233 35B1400184 35B1400195 35B1400201 35B1400227 35B1400187 35B1400196 35B1400102 35B1400205 35B1400206 35B1400208 35B1400214 35B1400181 35B1400190 35B1400209 35B1400230 35B1400239 35B1400247 35B1400249 35B1400193 35B1400251 35B1400252 35B1400221 35B1400167 35B1400207 35B1400211 35B1400219 35B1400222 35B1400260 35B1400212 35B1400224 35B1400241 35B1400242 35B1400246 35B1400218 35B1400229 35B1400232 35B1400237 35B1400235 35B1400146 35B1400173 35B1400216 35B1400220 35B1400225 35B1400226 35B1400231 35B1400259 35B1400262 35B1400265 35B1400274 35B1400283 35B1400186 35B1400223 35B1400215 35B1400248 35B1400261 35B1400266 35B1400268 35B1400243 35B1400250 35B1400254 35B1400163 35B1400255 35B1400256 35B1400267 35B1400270 35B1400273 35B1400275 35B1400278 35B1400281 35B1400287 35B1400290 35B1400303 35B1400253 35B1400279 35B1400285 35B1400177 35B1400213 35B1400245 35B1400264 35B1400282 35B1400284 35B1400286 35B1400288 35B1400289 35B1400296 35B1400302 35B1400305 35B1400307 35B1400292 35B1400298 35B1400168 35B1400293 35B1400310 35B1400313 35B1400316 35B1400318 35B1400320 35B1400291 35B1400272 35B1400309 35B1400234 35B1400295 35B1400322 35B1400090 35B1400238 35B1400258 35B1400317 35B1400324 35B1400326 35B1400327 35B1400328 35B1400204 35B1400271 35B1400301 35B1400306 35B1400312 35B1400315 35B1400323 35B1400340 35B1400341 35B1400333 35B1400332 35B1400336 35B1400338 35B1400342 35B1400330 35B1400345 35B1400346 35B1400350 35B1400355 35B1400359 35B1400367 35B1400373 35B1400321 35B1400308 35B1400244 35B1400329 35B1400354 35B1400371 35B1400314 35B1400319 35B1400344 35B1400348 35B1400365 35B1400369 35B1400375 35B1400377 35B1400378 35B1400349 35B1400364 35B1400370 35B1400347 35B1400368 35B1400383 35B1400331 35B1400372 35B1400356 35B1400382 35B1400299 35B1400385 35B1400388 35B1400263 35B1400396 35B1400400 35B1400339 35B1400357 35B1400337 35B1400384 35B1400392 35B1400401 35B1400335 35B1400407 35B1400393 35B1400395 35B1400404 35B1400411 35B1400376 35B1400408 35B1400389 35B1400390 35B1400410 35B1400413 35B1400387 35B1400386 35B1400353 35B1400415 35B1400417 35B1400421 35B1400358 35B1400397 35B1400405 35B1400419 35B1400426 35B1400428 35B1400435 35B1400399 35B1400439 35B1400442 35B1400257 35B1400361 35B1400402 35B1400423 35B1400431 35B1400444 35B1400446 35B1400445 35B1400449 35B1400452 35B1400457 35B1400458 35B1400466 35B1400434 35B1400409 35B1400425 35B1400448 35B1400455 35B1400144 35B1400236 35B1400300 35B1400379 35B1400437 35B1400438 35B1400468 35B1400472 35B1400482 35B1400486 35B1400489 35B1400490 35B1400491 35B1400492 35B1400493 35B1400495 35B1400496 35B1400499 35B1400500 35B1400501 35B1400502 35B1400505 35B1400506 35B1400507 35B1400094 35B1400128 35B1400459 35B1400414 35B1400454 3… (truncated, 274432 characters total — see the official FDA record for the full value)

Recalling firm:

Covidien Llc

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

Recall #:

86669

Lot/product code:

Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577

Recalling firm:

Ortho Clinical Diagnostics Inc

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

Recall #:

86700

Lot/product code:

(01) 00848486030193 (21), Serial numbers: 4200052, 4200095, 4200112, 4200117, 4200119, 4200167, 4200190, 4200193, 4200202, 4200203, 4200204, 4200226, 4200233, 4200235, 4200248, 4200250, 4200257, 4200269, 4200270, 4200288, 4200293, 4200305, 4200350, 4200373, 4200384, 4200387, 4200391, 4200397, 4200398, 4200400, 4200409, 4200436, 4200457, 4200459, 4200477, 4200488, 4200512, 4200540, 4200548, 4200550, 4200558, 4200624, 4200645, 4200653, 4200666, 4200717, 4200766, 4200774, 4200785, 4200789, 4200801, 4200806, 4200807, 4200816, 4200843, 4200856, 4200868, 4200904, 4200917, 4201000, 4201040, 4201068, 4201089, 4201102, 4201103, 4201121, 4201167, 4201218, 4201236, 4201238, 4201253, 4201296, 4201302, 4201366, 4201367, 4201376, 4201385, 4201408, 4201412, 4201442, 4201452, 4201454, 4201477, 4201490, 4201630, 4201661, 4201714, 4201752, 4201829, 4201831, 4201851, 4202009, 4202020, 4202038, 4202044, 4202062, 4202063, 4202122, 4202146, 4202162, 4202175, 4202315, 4202333, 4202626, 4202631, 4202659, 4202729, 4202742, 4202882, 4202987, 4203180, 4203198, 4203289, 4203424, 4203441, 4203649, 4203709, 4203728, 4203730, 4203731, 4203736, 4203807, 4203826, 4204015, 4204164, 4204389, 4204448, 4204539, 4204553, 4204577, 4204673, 4204812, 4204934, 4205093, 4205190, 4205380, 4205426, 4206219, 4206271, 4209023, 4209025, 4209044, 4209045, 4209046, 4209065, 4209066, 4209067, 4209068, 4209071, 4209149, 4209151, 4209155, 4209156, 4209157, 4209162, 4209164, 4209166, 4209167, 4209171, 4209185, 4209189, 4209210, 4209211, 4209213, 4209220, 4209244, 4209250, 4209252, 4209255, 4209256, 4209259, 4209261, 4209262, 4209267, 4209268, 4209271, 4209298, 4209299, 4209303, 4209304, 4209306, 4209308, 4209312, 4209317, 4209318, 4209345, 4209346, 4209357, 4209360, 4209363, 4209364, 4209365, 4209387, 4209388, 4209389, 4209398, 4209441, 4209443, 4209460, 4209463, 4209464, 4209466, 4209471, 4209472, 4209473, 4209474, 4209475, 4209476, 4209477, 4209486, 4209487, 4209491, 4209493, 4209494, 4209495, 4209496, 4209500, 4209519, 4209522, 4209526, 4209529, 4209531, 4209532, 4209533, 4209535, 4209541, 4209542, 4209543, 4209546, 4209597, 4209598, 4209599, 4209600, 4209601, 4209602, 4209604, 4209605, 4209606, 4209607, 4209608, 4209609, 4209610, 4209611, 4209612, 4209613, 4209614, 4209615, 4209616, 4209621, 4209628, 4209632, 4209634, 4209635, 4209637, 4209639, 4209640, 4209647, 4209667, 4209671, 4209685, 4209694, 4209698, 4209734, 4209764, 4209771, 4209774, 4209775, 4209776, 4209777, 4209778, 4209779, 4209780, 4209781, 4209782, 4209783, 4209784, 4209785, 4209786, 4209787, 4209788, 4209789, 4209790, 4209791, 4209792, 4209793, 4209794, 4209795, 4209796, 4209797, 4209798, 4209799, 4209800, 4209801, 4209802, 4209803, 4209804, 4209805, 4209806, 4209807, 4209808, 4209809, 4209810, 4209811, 4209812, 4209813, 4209814, 4209815, 4209816, 4209817, 4209818, 4209819, 4209820, 4209821, 4209822, 4209823, 4209834, 4209849, 4209859, 4209860, 4209863, 4209927, 4209928, 4209929, 4209930, 4209931, 4209932, 4209933, 4209934, 4209935, 4209936, 4209937, 4209938, 4209939, 4209940, 4209941, 4209942, 4209943, 4209945, 4209946, 4209947, 4209948, 4209949, 4209950, 4209951, 4209952, 4209954, 4209955, 4209956, 4209957, 4209959, 4209960, 4209961, 4209962, 4209963, 4209964, 4209965, 4209966, 4209967, 4209968, 4209969, 4209985, 4209986, 4209987, 4209988  Updated information submitted: Serial numbers removed from 12/23/20 letter: 4200112, 4200117, 4200202, 4201412, 4201490, 4201661; reason: These devices are still in scope and exhibit the issue. However, it was found that none of these devices were distributed to a customer. Therefore, they were removed from the attachment in the letter and are within Stryker control.  Serial Numbers added to the recall letter: 4209292, 4209646, 4209841, 4202629, 4203963; reason: These devices were originally thought to be in Stryker control, but were shipped to customers.   Serial Numbers added to the recall letter: 4209917, 4209922, 4209924; reason: These devices were shipped to Stryker OUS distributor and were thought to be distributed to customers. (Firm later confirmed that the units are under Stryker control.)

Recalling firm:

Mako Surgical Corporation

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

Recall #:

D-0067-2021

Lot/product code:

MET200101, MET200301 EXP 05/2022

Recalling firm:

Nostrum Laboratories Inc

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

Recall #:

D-0068-2021

Lot/product code:

MET100201, MET100401 EXP 05/2022

Recalling firm:

Nostrum Laboratories Inc

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:

D-0103-2021

Lot/product code:

Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, Exp 7/31/2022; C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, Exp 8/31/2022; C240GM, C240GP, C240GQ, C240GR, Exp 9/30/2022; b) C191KR, Exp 7/31/2020

Recalling firm:

Sunstar Americas, Inc.

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

Recall #:

86699

Lot/product code:

Order No. 0350, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)

Recalling firm:

Chromsystems Instruments & Chemicals GmbH

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

Recall #:

86699

Lot/product code:

Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)

Recalling firm:

Chromsystems Instruments & Chemicals GmbH

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

Recall #:

86699

Lot/product code:

Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)

Recalling firm:

Chromsystems Instruments & Chemicals GmbH

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

Recall #:

88137

Lot/product code:

041520022A, 061920022A, and 081120022A

Recalling firm:

Luminex Corporation

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

Recall #:

88137

Lot/product code:

050620026A and 072120026B,

Recalling firm:

Luminex Corporation

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

Recall #:

88137

Lot/product code:

030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A

Recalling firm:

Luminex Corporation

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

Recall #:

88137

Lot/product code:

030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A

Recalling firm:

Luminex Corporation

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

Recall #:

88137

Lot/product code:

030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, 040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, 042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, 070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and 091120024A

Recalling firm:

Luminex Corporation

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

Recall #:

88137

Lot/product code:

030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A

Recalling firm:

Luminex Corporation

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

Recall #:

86697

Lot/product code:

Model: V60 Part Number: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS  Serial Numbers: 100039155 100054624 100054738

Recalling firm:

Respironics California, LLC