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Recalls affecting Montana

Data last updated: September 11, 2026 at 1:08 PM UTC

16,414 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89

Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

Full report

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

Recall #:
88880
Lot/product code:
Product Description/List Number/Serial Numbers: ARCHITECT i1000SR UDI: (01)00380740001537(21)I1SR12345(240)01L8601 List Number: 1L86 Serial Numbers: i1SR00101 i1SR00102 i1SR00103 i1SR00104 i1SR00105 i1SR00106 i1SR00107 i1SR00108 i1SR00109 i1SR00110 i1SR00111 i1SR00112 i1SR00113 i1SR00114 i1SR00115 i1SR00116 i1SR00117 i1SR00118 i1SR00119 i1SR00120 i1sr00121 i1SR00122 i1SR00124 i1SR00201 i1SR00202 i1SR00203 i1SR00204 i1SR00205 i1SR00206 i1SR00207 i1SR00208 i1SR00209 i1SR00210 i1SR00211 i1SR00212 i1SR00213 i1SR00214 i1SR00215 i1SR00216 i1SR00217 i1SR00218 i1SR00219 i1SR00220 i1SR00221 i1SR00222 i1SR00223 i1SR00224 i1SR00225 i1SR00226 i1SR00227 i1SR00228 i1SR00229 i1SR00230 i1SR00231 i1SR00232 i1SR00233 i1SR00234 i1SR00235 i1SR00236 i1SR00237 i1SR00238 i1SR00239 i1SR00240 i1SR00241 i1SR00242 i1SR01001 i1SR01002 i1SR01003 i1SR01004 i1SR01005 i1SR01006 i1SR01007 i1SR01008 i1SR01009 i1SR01010 i1SR01011 i1SR01012 i1SR01013 i1SR01014 i1SR01015 i1SR01016 i1SR01017 i1SR01018 i1SR01019 i1SR01020 i1SR01021 i1SR01022 i1SR01023 i1SR01024 i1SR01025 i1SR01026 i1SR01027 i1SR01028 i1SR01029 i1SR01030 i1SR01031 i1SR01032 i1SR01033 i1SR01034 i1SR01035 i1SR01036 i1SR01037 i1SR01038 i1SR01039 i1SR01040 i1SR01041 i1SR01042 i1SR01043 i1SR01044 i1SR01045 i1SR01046 i1SR01047 i1SR01048 i1SR01049 i1SR01050 i1SR01051 i1SR01052 i1SR01053 i1SR01054 i1SR01055 i1SR01056 i1SR01058 i1SR01059 i1SR01060 i1SR01061 i1SR01062 i1SR01063 i1SR01064 i1SR01065 i1SR01066 i1SR01067 i1SR01068 i1SR01069 i1SR01070 i1SR01071 i1SR01072 i1SR01073 i1SR01074 i1SR01075 i1SR01076 i1SR01077 i1SR01078 i1SR01079 i1SR01080 i1SR01082 i1SR01083 i1SR01084 i1SR01085 i1SR01086 i1SR01087 i1SR01088 i1SR01089 i1SR01090 i1SR01091 i1SR01092 i1SR01093 i1SR01094 i1SR01095 i1SR01096 i1SR01097 i1SR01098 i1SR01099 i1SR01100 i1SR01101 i1SR01102 i1SR01103 i1SR01104 i1SR01105 i1SR01106 i1SR01107 i1SR01108 i1SR01109 i1SR01110 i1SR01111 i1SR01112 i1SR01113 i1SR01114 i1SR01115 i1SR01116 i1SR01117 i1SR01118 i1SR01119 i1SR01120 i1SR01121 i1SR01122 i1SR01123 i1SR01124 i1SR01125 i1SR01126 i1SR01127 i1SR01128 i1SR01129 i1SR01130 i1SR01131 i1SR01132 i1SR01133 i1SR01134 i1SR01136 i1SR01137 i1SR01138 i1SR01139 i1SR01140 i1SR01141 i1SR01142 i1SR01143 i1SR01144 i1SR01145 i1SR01146 i1SR01147 i1SR01148 i1SR01149 i1SR01150 i1SR01151 i1SR01152 i1SR01153 i1SR01154 i1SR01155 i1SR01156 i1SR01157 i1SR01158 i1SR01159 i1SR01160 i1SR01161 i1SR01162 i1SR01163 i1SR01164 i1SR01165 i1SR01166 i1SR01167 i1SR01168 i1SR01169 i1SR01170 i1SR01171 i1SR01172 i1SR01173 i1SR01174 i1SR01175 i1SR01176 i1SR01177 i1SR01178 i1SR01179 i1SR01180 i1SR01181 i1SR01182 i1SR01183 i1SR01184 i1SR01185 i1SR01186 i1SR01187 i1SR01188 i1SR01189 i1SR01190 i1SR01191 i1SR01192 i1SR01193 i1SR01194 i1SR01195 i1SR01196 i1SR01197 i1SR01198 i1SR01199 i1SR01200 i1SR01201 i1SR01202 i1SR01203 i1SR01204 i1SR01205 i1SR01206 i1SR01207 i1SR01208 i1SR01209 i1SR01210 i1SR01211 i1SR01212 i1SR01213 i1SR01214 i1SR01215 i1SR01216 i1SR01217 i1SR01218 i1SR01219 i1SR01220 i1SR01221 i1SR01222 i1SR01223 i1SR01224 i1SR01225 i1SR01226 i1SR01227 i1SR01228 i1SR01229 i1SR01230 i1SR01231 i1SR01232 i1SR01233 i1SR01234 i1SR01235 i1SR01236 i1SR01237 i1SR01238 i1SR01239 i1SR01240 i1SR01241 i1SR01242 i1SR01243 i1SR01244 i1SR01245 i1SR01246 i1SR01247 i1SR01248 i1SR01249 i1SR01250 i1SR01251 i1SR01252 i1SR01253 i1SR01254 i1SR01255 i1SR01256 i1SR01257 i1SR01258 i1SR01259 i1SR01260 i1SR01261 i1SR01262 i1SR01263 i1SR01264 i1SR01265 i1SR01266 i1SR01267 i1SR01268 i1SR01269 i1SR01270 i1SR01271 i1SR01272 i1SR01273 i1SR01274 i1SR01275 i1SR01276 i1SR01277 i1SR01278 i1SR01279 i1SR01280 i1SR01281 i1SR01282 i1SR01283 i1SR01284 i1SR01285 i1SR01286 i1SR01287 i1SR01288 i1SR01289 i1SR01290 i1SR01291 i1SR01292 i1SR01293 i1SR01294 i1SR01295 i1SR01296 i1SR01297 i1SR01298 i1SR01299 i1SR01300 i1SR01301 i1SR01302 i1SR01303 i1SR01304 i1SR01305 i1SR01306 i1SR01308 i1SR01309 i1SR01310 i1SR01311 i1SR01312 i1SR01313 i1SR01314 i1SR01315 i1SR01316 i1SR01317 i1SR01318 i1SR01319 i1SR01320 i1SR01321 i1SR01322 i1SR01323 i1SR01324 i1SR01325 i1SR01326 i1SR01327 i1SR01328 i1SR01329 i1SR01330 i1SR01331 i1SR01332 i1SR01333 i1SR01334 i1SR01335 i1SR01336 i1SR01337 i1SR01338 i1SR01339 i1SR01340 i1SR01341 i1SR01342 i1SR01343 i1SR01344 i1SR01345 i1SR01346 i1SR01347 i1SR01348 i1SR01349 i1SR01350 i1SR01351 i1SR01352 i1SR01353 i1SR01354 i1SR01355 i1SR01356 i1SR01357 i1SR01358 i1SR01359 i1SR01360 i1SR01361 i1SR01362 i1SR01363 i1SR01364 i1SR01365 i1SR01366 i1SR01367 i1SR01368 i1SR01369 i1SR01370 i1SR01371 i1SR01372 i1SR01373 i1SR01374 i1SR01375 i1SR01376 i1SR01377 i1SR01378 i1SR01379 i1SR01380 i1SR01381 i1SR01382 i1SR01383 i1SR01384 i1SR01385 i1SR01386 i1SR01387 i1SR01388 i1SR01389 i1SR01390 i1SR01391 i1SR01392 i1SR01393 i1SR01394 i1SR01395 i1SR01396 i1SR01397 i1SR01398 i1SR01399 i1SR01400 i1SR01401 i1SR01402 i1SR01403 i1SR01404 i1SR01405 i1SR01406 i1SR01407 i1SR01408 i1SR01409 i1SR01410 i1SR01411 i1SR01412 i1SR01413 i1SR01414 i1SR01415 i1SR01416 i1SR01417 i1SR01418 i1SR01419 i1SR01420 i1SR01421 i1SR01422 i1SR01423 i1SR01424 i… (truncated, 311449 characters total — see the official FDA record for the full value)
Recalling firm:
Abbott Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers: 0112010 0209001 0214002 0309031 0313007BFIX 0411002 0609010FIX 0710001 0711008 0713011C 0809009 0813032CFIX 091402 1013009C 1013015C 1109017 1214005 2015090019 2015110003 2016030001 2016040012 2016060016 2016090003 2016110002 2017010005 2017060010 2017080010 QTMAA-4-095 QTM-AB-10-149 QTM-M-4-102FIX W110954 W351106 W60413 0114011 0212004 0214007 0312021 0313010B 0413003B 0612001B 0710003 0711008FIX 0713018C 0811017 0813033C 1011010 1013010C 1014004 1111002 2015040009 2015090021 2015110004 2016030002 2016040015 2016060020 2016090004 2016110003 2017020004 2017060013 AFZFIX QTMAA4101 QTM-AB-12-164 QTMY-11-0201 W204996 W381180 W605041 0114013 0212008 0214008 0312024 0313011B 0511002 0612003B 0710008 0711009 0714007 0811021 0813034C 1011010FIX 1013011C 1109008 1213005C 2015060003 2015100004 2015110009 2016040001 2016040018 2016070003 2016090007 2016110004 2017030002 2017080002 ATM-AA-4-106 QTMAA-4-102 QTM-AB-12-165 QTMY-12-0208 W2A1022 W381192 W708311FIX 0115006 0212010 0215005 0312033 0409005 0511003 0612010B 0710008FIX 0712009B 0809004 0811021FIX 0814011FIX 1012006B 1013012C 1109014 1213006C 2015090012 2015100006FIX 2015110010 2016040002 2016060012 2016070007 2016090014 2016120002 2017030005 2017080003 GHILL QTMAA6116 QTMAB3067 QTMY70139 W2B1036 W604009  0115007 0214001 0215007 0313001B 0409006 0511003FIX 0612016B 0711006 0713001C 0809007 0813029C 0814012 1013006C 1013014C 1109015 1214003 2015090015 2015110001 2016020006 2016040007 2016060013 2016080002 2016110001 2017010002 2017030009 2017080006 IUY80207 QTMAA-6-116 QTM-AB-9135 W107893 W2C1054 W604013
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers:  Lot/Serial Number 0115001 0115001 0115001 0115002 0115003 0115004 0115005 0115005 0115006 0115007 0115007 0115008 0115009 0115010 0115011 0115012 0115012 0115013 0115014 0115015 0115015 0115016 0115017 0115018 0115019 0115020 0115021 0115022 0115023 0115024 0115025 0115026 0115027 0115028 0115029 0115030 0115031 0115032 0115033 0115034 0115035 0115036 0115037 0115038 0115039 0115040 0215001 0215003 0215004 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215019 0215020 0215021 1114001 1114002 1114003 1114004 1114005 1114006 1114007 1114008 1114009 1114010 1114011 1114012 1114013 1114013 1114014 1114015 1114016 1114017 1114018 1114019 1114020 1114021 1114022 1114023 1114024 1114025 1114026 1114027 1114028 1214001 1214002 1214003 1214004 1214005 1214005 1214006 1214007 2015060001 2015060002 2015060003 2015060004 2015060004 2015060005 2015060006 2015060007 2015060008 2015060009 2015060010 2015060011 2015060011 2015060012 2015060013 2015060014 2015080001 2015080002 2015080003 2015080004 2015080005 2015080006 2015080007 2015080008 2015080009 2015080010 2015080011 2015080012 2015080013 2015080014 2015080015 2015080016 2015080016 2015080017 2015080018 2015080019 2015080020 2015080021 2015080022 2015080023 2015080023 2015080024 2015080025 2015090005 2015090006 2015090007 2015090008 2015090009 2015090010 2015090011 2015090012 2015090013 2015090013 2015090014 2015090015 2015090015 2015090016 2015090017 2015100001 2015100002 2015100003 2015100004 2015110001 2015110002 2015110003 2015110004 2015110005 2015110006 2015110007 2015110007 2015110008 2015110009 2015110010 2015110011 2015110012 2015110013 2015110014 2015110015 2015110016 2015110017 2015110018 2015110019 2016020001 2016020002 2016020003 2016020004 2016020004 2016020005 2016020006 2016020007 2016020008 2016020009 2016020010 2016020011 2016020012 2016020012 2016020013 2016020014 2016020015 2016020016 2016020017 2016020018 2016020019 2016030001 2016030002 2016030003 2016030003 2016030004 2016030005 2016030006 2016030007 2016030008 2016030009 2016030010 2016030011 2016030012 2016030013 2016030014 2016030015 2016030016 2016030017 2016040003 2016040004 2016040005 2016040006 2016040007 2016040008 2016040009 2016040010 2016040011 2016050001 2016050002 2016050003 2016050004 2016050005 2016050006 2016050007 2016050008 2016050009 2016050010 2016050011 2016050012 2016050013 2016050014 2016050015 2016050016 2016050017 2016050018 2016050019 2016050020 2016050021 2016050022 2016050023 2016050024 2016050025 2016050026 2016050027 2016050028 2016050029 2016050030 2016050031 2016050032 2016050033 2016050034 2016060001 2016060002 2016060003 2016060004 2016060005 2016060006 2016060007 2016060008 2016060009 2016060009 2016060010 2016060011 2016060012 2016060013 2016060014 2016060015 2016060016 2016060017 2016060018 2016060019 2016060020 2016060021 2016060022 2016060023 2016060024 2016060025 2016060026 2016060027 2016060028 2016060028 2016060029 2016060031 2016070001 2016070002 2016070003 2016070004 2016070005 2016070005 2016070006 2016070007 2016070008 2016070008 2016070009 2016070010 2016070011 2016070012 2016070013 2016070014 2016070015 2016070016 2016070017 2016070018 2016070019 2016070020 2016070023 2016070024 2016070025 2016070026 2016070027 2016070027 2016070028 2016070029 2016070030 2016070031 2016080001 2016080002 2016080003 2016080004 2016080005 2016080006 2016080007 2016080008 2016080009 2016080010 2016080010 2016080011 2016080012 2016080013 2016080014 2016080015 2016080016 2016080017 2016080018 2016080019 2016080020 2016080021 2016080022 2016080023 2016080024 2016080025 2016080026 2016080026 2016080027 2016080029 2016080030 2016080031 2016080032 2016100001 2016100002 2016100003 2016100004 2016100005 2016100006 2016100007 2016100008 2016100009 2016100010 2016100011 2016100012 2016100013 2016100014 2016100015 2016100016 2016100017 2016100018 2016100019 2016100021 2016100022 2016100023 2016100024 2016100025 2016100026 2016100027 2016100028 2016100029 2016100030 2016100031 2016100032 2016100033 2016100033 2016100034 2016100035 2016120001 2016120002 2016120003 2016120004 2016120005 2016120006 2016120007 2016120008 2016120009 2016120010 2016120011 2017010005 2017010006 2017010007 2017010008 2017010008 2017010009 2017010010 2017010011 2017010012 2017010013 2017010014 2017010015 2017010016 2017010017 2017010018 2017010019 2017010020 2017010021 2017010023 2017010024 2017020006 2017020006 2017020007 2017020008 2017020009 2017020010 2017020011 2017020012 2017020013 2017020014 2017020015 2017020016 2017020017 2017020018 2017020019 2017020020 2017040001 2017040002 2017040003 2017040004 2017040005 2017040006 2017040007 2017040008 2017040009 2017040010 2017040011 2017040012 2017040013 2017040014 2017050001 2017050002 2017050003 2017050004 2017050005 2017050006 2017050007 2017050008 2017050008 2017050009 2017050010 2017050011 2017050012 2017050013 2017050014 2017060001 2017060002 201706000… (truncated, 17167 characters total — see the official FDA record for the full value)
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers: 2018100001 2018100002 2018100003
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers:  0209001 0209002 0209003 0209004 0211001 0211002 0211003 0211004 0211005 0211006 0211007 0211008 0211009 0211010 0211011 0211012 0211013 0211014 0211015 0211016 0211017 0211018 0211019 0211020 0211021 0211022 0211023 0211024 0211025 0211026 0211027 0211028 0211029 0211030 0211031 0211032 0211033 0211034 0211035 0211036 0211037 0211038 0211039 0211040 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215020 0215021 0215022 0215023 0215024 0215025 0215026 0215027 0215028 0215029 0215030 0215031 0215032 0215033 0215034 0215035 0215036 0314014 0314014KF 0314019 0410001 0410002 0410003 0410004 0410005 0410006 0410007 0410008 0410009 0410010 0410011 0410012 0410013 0410014 0410015 0410016 0410017 0410018 0410019 0410020 0410021 0410022 0410023 0410024 0410025 0410026 0410027 0410028 0410029 0410030 0410031 0410032 0410033 0410034 0410035 0410036 0410037 0410038 0410039 0410040 0414009 0414010 0414011 0414013 0414015 0414016 0414019 0414021 0414023 0414024 0510001 0510002 0510003 0510004 0612001B 0612002B 0612003B 0612003BTP 0612004B 0612005B 0612006B 0612007B 0612008B 0612008BTP 0612009B 0612010B 0612011B 0612012B 0612013B 0612014B 0612015B 0612016B 0612017B 0612018B 0612019B 0612020B 0612021B 0612022B 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0612029B 0612030B 0612031B 0612032B 0612033B 0612034B 0612035B 0612036B 0612037B 0612038B 0612039B 0612040B 0613001C 0613002C 0613003C 0613004C 0613005C 0613006C 0613007C 0613008C 0613009C 0613010C 0613011C 0613012C 0613013C 0613014C 0613015C 0613016C 0613017C 0613018C 0613019C 0613020C 0613021C 0613022C 0613023C 0711001 0711002 0711003 0711004 0711005 0711006 0711007 0711008 0711009 0711010 0711011 0711012 0711013 0711014 0711015 0711016 0711017 0711018 0711019 0711020 0711022 0711023 0711024 0711025 0711027 0711028 0711029 0711030 0711031 0711032 0711033 0711034 0711035 0711036 0711037 0711038 0711039 0711040 0714001 0714002 0714003 0714004 0714004KF 0714005 0714006 0714007 0714008 0714009 0714009KF 0714010 0714011 0714012 0714013 0714014 0714015 0714016 0714017 0714018 0714019 0714020 0714021 0714022 0714023 0714024 0714025 0714026 0714027 0714028 0910012 0910013 0910014 0910015 0910016 0910017 0910018 0910019 0910020 0910021 0910022 0910023 0910024 0910025 0910026 0910027 0910028 0910029 0910030 0910031 0910032 0910033 0910034 0910035 0910036 0910037 0910038 0910039 0910040 0910041 0910042 0910043 0910044 0910045 0910046 0910047 0910048 0910049 0910050 0910051 0910052 0910053 0910054 0910055 0911002 0911003 1011001 1011002 1011003 1011004 1011005 1011006 1011007 1011008 1011009 1011010 1011011 1011012 1011013 1011014 1011015 1011016 1011017 1011018 1011019 1011020 1011021 1011022 1011023 1011024 1011025 1011026 1011027 1011028 1011029 1011030 1011031 1011032 1011033 1011034 1011035 1011036 1011037 1011038 1011039 1011040 1014001 1014002 1014003 1014004 1014004KF 1014005 1014006 1014007 1014008 1014009 1014010 1014011 1014011KF 1014012 1014013 1014014 1014015 1014016 1014017 1014018 1014019 1014020 1014020KF 1014021 1014022 1014023 1014024 1014025 1209005 1209006 1209007 1209008 1209009 1209010 1209011 1209012 1209013 1209014 1209015 1209016 1209017 1209018 1209019 1209020 1209021 1209022 1209023 1209024 1209025 1209026 1209027 1209028 1209029 1209030 1209031 1209032 1209033 1209034 1209035 1209036 1209037 1209038 1209039 1209040 1209041 1209042 1209043 1209044 1212001B 1212002B 1212003B 1212004B 1212005B 1212006B 1212007B 1212008B 1212008BTP 1212009B 1212010B 1212011B 1212012B 1212013B 1212014B 1212015B 1212016B 1212017B 1212018B 1212019B 1212020B 1212021B 1212022B 1212023B 1212024B 1212025B 2015030001 2015030002 2015050001 2015050002 2015050003 2015050004 2015050005 2015050006 2015050007 2015050008 2015050009 2015050010 2015050011 2015050012 2015050013 2015050014 2015050015 2015050016 2015050017 2015050018 2015050019 2015050020 2015050021 2015050022 2015050023 2015050024 2015050025 2015050026 2015050027 2015050028 2015050029 2015050030 2015050031 2015050032 2015050033 2015050034 2015050035 2015050036 2015050037 2015060001 2015060002 2015060003 2015060004 2015060005 2015060006 2015070001 2015070002 2015070003 2015070005 2015070006 2015070007 2015080001 2015080002 2015080003 2015080004 2015080005 2015080006 2015080007 2015080008 2015080009 2015080010 2015080011 2015080012 2015080013 2015080014 2015080015 2015080016 2015080017 2015080018 2015080019 2015080020 2015080021 2015080022 2015080023 2015080024 2015080025 2015090001 2015090002 2015090003 2015090004 2015090005 2015120001 2015120002 2015120003 2015120004 2015120005 2015120006 2015120007 2015120008 2015120009 2015120010 2015120011 2015120012 2015120013 2015120014 2015120015 2015120016 2015120017 2015120018 2015120019 2015120020 2015120021 2015120022 2015120023 2015120024 2015120025 2015120026 2015120027 2015120028 2015120029 2015120030 2016030001 2016030002 2016030003 2016030004 2016030… (truncated, 5904 characters total — see the official FDA record for the full value)
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers:  0215002 1214007 2015050001  2016060030 2016060031 2016070002 2016070004 2016070012 2016070017 2016070021 2016070022 2016070026 2016070027 2016070028 2016070030 2016070031 2016080002 2016080004 2016080007 2016080009 2016080015 2016080016 2016080017 2016080018 2016080019 2016080020 2016080021 2016080022 2016080025 2016080026 2016080027 2016080029 2016080031 2016080033 2016080034 2016080035 2016080036 2016100002 2016100004 2016100009 2016100010 2016100012 2016100013 2016100014 2016100016 2016100017 2016100018 2016100021 2016100023 2016100024 2016100025 2016100027 2016100028  2015050016 2015050017 2015050018 2015050019 2015050020 2015110007 2016030001 2016030002 2016030006 2016030007 2016030013 2016030015 2016040001 2016040002 2016040004 2016040006 2016040007 2016040010 2016050004 2016050006 2016050007 2016050010 2016050012 2016050013 2016050015 2016050016 2016050019 2016050029 2016050031 2016050034 2016060001 2016060002 2016060003 2016060004 2016060006 2016060007 2016060009 2016060012 2016060013 2016060016 2016060021 2016060022 2016060023 2016060025 2016060026 2016060028 2016060029 2016100029 2016100033 2016100034 2016100035 2016120002 2016120003 2016120004 2016120005 2016120008 2016120010 2016120011 2017010001 2017010002 2017010003 2017010004 2017010005 2017010006 2017010007 2017010009 2017010010 2017010011 2017010012 2017010015 2017010016 2017010018 2017010020 2017010023 2017020001 2017020002 2017020003 2017020004 2017020005 2017020006 2017020008 2017020011 2017020012 2017020013 2017020014 2017020017 2017020019 2017040001 2017040002 2017040003 2017040005 2017040008 2017040015 2017050008 2017050012 2017050013 2017050014 2017050015 2017050016 2017050017 2017060003 2017060004 2017060006 2017060010 2017060011 2017060012 2017060013 2017060014 2017060015 2017070002 2017070003 2017070005 2017070006 2017070009 2017070010 2017070012 2017070013 2017070015 2017080001 2017080003 2017080004 2017080005 2017080007 2017080010 2017080011 2017080015 2017090001 2017090003 2017090006 2017090009 2017090010 2017090014 2017110010 2017110012 2017110013 2017110015 2017110016 2017110017 2017110019 2017110026 2017110027 2017110028 2018100043 2019080030 2019080051 2019080052 2019100001  2019100002 2019100003 2019100017 2019100018 2019100019 2019100020 2020030021 2020040001 2020040002 2020040003 2020040004 2020070021 2020070022 2020070023 2020070024 2020070025 2020120001 2021010002 2021010003 2021010004 2021030041 2021030042 2021030043 2021030044 2021030045 2021040021 2021040022
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers: 2017040001 2017040002 2017040003 2017040004 2017040005 2018030001 2018030002 2018030003 2018030004 2018100004 2018100005 2018100006 2018120001 2018120002 2018120003 2019010001 2019010002 2019010003 2019010004 2019010005 2019030001 2019030002 2019030003 2019030004 2019070001 2019070002 2019070003 2019070004 2019070005 2019070006 2019100001 2019100004 2019100005 2019120001 2019120002 2019120003 2019120004 2019120005 2019120006 2020030001 2020030002 2020030003 2020030004 2020030005 2020060001 2020060002 2020060003 2020060004 2020060005 2020060006 2020080001 2020080002 2020080003 2020080004 2020080005 2020080006 2020110001 2020110002 2020110003 2020110004 2020110005 2020110006 2020120001 2020120002 2020120003 2020120004 2020120005 2020120006 2021010001 2021010002 2021010003 2021010004 2021010005
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

Hemodialysis Delivery System, Software Version 2.x.

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

ALL 50 STATES
Full report

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

Recall #:
88695
Lot/product code:
Software Version 2.x.;   Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378, 107379, 107380, 107381, 107382, 107383, 107384, 107385, 107386, 107387, 107483, 107484, 107485, 107486, 107487, 107488, 107489, 107490, 107491, 107492, 107493, 107494, 107495, 107496, 107497, 107498, 107499, 107500, 107501, 107502, 107503, 107504, 107505, 107506, 107507, 107508, 107509, 107510, 107511, 107512, 107818, 107819, 107820, 107821, 107822, 107823, 107824, 107825, 107826, 107827, 107878, 107879, 107880, 107881, 107882, 107883, 107884, 107885, 107886, 107887, 108193, 108194, 108195, 108196, 108197, 108198, 108199, 108200, 108201, 108202, 108203, 108204, 108205, 108206, 108207, 108208, 108209, 108210, 108211, 108212, 108303, 108304, 108305, 108306, 108307, 108308, 108309, 108310, 108311, 108312, 108453, 108454, 108455, 108456, 108457, 108458, 108459, 108460, 108461, 108462, 108503, 108504, 108505, 108506, 108507, 108508, 108509, 108510, 108511, 108512, 108777, 108778, 108779, 108780, 108781, 108782, 108783, 108784, 108785, 108786, 108842, 108843, 108844, 108846, 108847, 108848, 108849, 108850, 108851, 100121, 103416, 103417, 103418, 103419, 103420, 103421, 103422, 103423, 103424, 103425, 108845, 108934, 108935, 108936, 108938, 108940, 108942, 108947, 108951, 108952, 108954, 108956, 108958, 109081, 109082, 109083, 109084, 109085, 109086, 109087, 109088, 109089, 109090, 109091, 109092, 109093, 109094, 109095, 109096, 109097, 109098, 109099, 109100, 109171, 109172, 109175, 109176, 109178, 109179, 109180, 109181, 109182, 109183, 109186, 109189, 109190, 109324, 109325, 109326, 109327, 109328, 109329, 109330, 109331, 109332, 109333, 109334, 109335, 109336, 109337, 109338, 109339, 109340, 109341, 109342, 109343, 109344, 109345, 109346, 109347, 109348, 109349, 109350, 109551, 109552, 109553, 109554, 109555, 109556, 109557, 109558, 109559, 109560, 109561, 109562, 109563, 109564, 109565, 109566, 109567, 109568, 109569, 109570, 109571, 109572, 109573, 109574, 109575, 109576, 109577, 109578, 109579, 109580, 109740, 109741, 109742, 109743, 109744, 109745, 109746, 109747, 109748, 109749, 109750, 109751, 109752, 109753, 109754, 109755, 109756, 109757, 109758, 109759, 109760, 109761, 109762, 109763, 109764, 109765, 109766, 109767, 109768, 109769, 109810, 109811, 109812, 109813, 109814, 109815, 109816, 109817, 109818, 109819, 109820, 109821, 109822, 109823, 109824, 109825, 109826, HVER5, 101132, 101209, 101218, 101219, 101220, 101221, 101222, 101223, 101224, 101225, 101226, 101227, 101228, 101279, 101280, 101281, 101282, 101283, 101284, 101285, 101286, 101287, 101288, 101289, 101290, 101291, 101292, 101293, 101321, 101322, 101323, 101324, 101325, 101326, 101327, 101328, 101329, 101330, 101331, 101342, 101343, 101344, 101345, 101346, 101347, 101348, 101349, 101350, 101351, 101352, 101353, 101354, 101355, 101356, 101387, 101388, 101389, 101390, 101391, 101392, 101393, 101394, 101395, 101396, 101397, 101398, 101419, 101420, 101421, 101422, 101423, 101424, 101425, 101426, 101427, 101428, 101448, 101449, 101450, 101451, 101452, 101453, 101454, 101455, 101456, 101457, 101608, 101609, 101610, 101611, 101612, 101613, 101614, 101615, 101616, 101617, 101688, 101689, 101690, 101691, 101692, 101693, 101694, 101695, 101696, 101697, 101749, 101750, 101751, 101752, 101753, 101754, 101755, 101756, 101757, 101758, 101789, 101790, 101791, 101792, 101793, 101794, 101795, 101796, 101798, 102140, 102141, 102142, 102143, 102144, 102145, 102146, 102147, 102148, 102149, 102150, 102151, 102152, 102153, 102154, 102155, 102156, 102157, 102158, 102159, 102306, 102307, 102308, 102309, 102310, 102311, 102312, 102313, 102314, 102315, 102316, 102317, 102318, 102319, 102320, 102321, 102322, 102323, 102324, 102325, 102326, 102327, 102328, 102329, 102330, 102331, 102332, 102333, 102334, 102335, 102336, 102352, 102353, 102354, 102355, 102356, 102358, 102359, 102360, 102361, 102362, 102363, 102364, 102365, 102366, 102397, 102398, 102399, 102400, 102401.102402, 102404, 102405, 102406, 102407, 102408, 102409, 102410, 102411, 102412, 102413, 102414, 102415, 102416, 102417, 102418, 102419, 102420, 102421, 102422, 102423, 102424, 102425, 102426, 102457, 102458, 102459, 102460, 102461, 102462, 102463, 102464, 102465, 102466, 102467, 102468, 102469, 102470, 102471, 102487, 102488, 102489, 102490, 102491, 102492, 102493, 102494, 102495, 102496, 102497, 102498, 102499, 102500, 102501, 102876, 102877, 102878, 102879, 102880, 102881, 102882, 102883, 102884, 102885, 102886, 102887, 102888, 102889, 102890, 102891, 102892, 102893, 102894, 102895, 102896, 102897, 102898, 102899, 102900, 102921, 102922, 102923, 102924, 102925, 102926, 102927, 102928, 102929, 102930, 103186, 103187, 103188, 103189, 103190, 103191, 103192, 103193, 103194, 103195, 103196, 103197, 103198, 103199, 103200, 103201, 103202, 103203, 103204, 103205, 103206, 103207, 103208, 103209, 103210, 103211, 103212, 103213, 103214, 103215, 103216, 103217, 103218, 103219, 103220, 103221, 103… (truncated, 34214 characters total — see the official FDA record for the full value)
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 30, 2021

MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.

Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

ALL 50 STATES
Full report

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

Recall #:
88868
Lot/product code:
Saline DV Breast Implant Codes with lots manufactured impacted by the Recall Product Code/UDI GTIN Code: 3501610/81317001171 Lot Numbers: 9528016 9558223 3501620/81317001195 Lot Numbers: 9576451 9574053 9574859 3501625/81317001201 Lot Numbers: 9539273 9549488 9567250 9583791 9585571 9584309 9587067 3501630/81317001218 Lot Numbers: 9534032 9538574 9546472 9556176 9570169 9570471 9572394 9611046 9611964 9611603 9622517 3501635/81317001225 Lot Numbers: 9529384 9531109 9540916 9544819 9535775 9553669 9552230 9568916 9566957 9565272 9575831 9617819 3501640/81317001232 Lot Numbers: 9533837 9537342 9534030 9534353 9545543 9553337 9550675 9555186 9580874 9583024 9583793 9590274 9592612 9614775 9617814 9614478 3501645/81317001249 Lot Numbers: 9530917 9531112 9535132 9540919 9546777 9550164 9550487 9547976 9549490 9559882 9578300 9580414 9582184 9583026 9582572 9631722 9629900 3501650/81317001256 Lot Numbers: 9529112 9534355 9527435 9542799 9550485 9553671 9553110 9573299 9576971 9576298 9574861 9577403 9576683 9587327 9590029 9589074 9611045 9611601 9629494 3501655/81317001263 Lot Numbers: 9535386 9539275 9547111 9553108 9555184 9555923 9569246 9557445 9597482 9600888 9603191 9598143 9605660 9607486 3501660/81317001270 Lot Numbers: 9533291 9528580 9537339 9553339 9558222 9559143 9561193 9582182 9583025 9591674 9611963 9614772 9614480 9614774 9615516 3501670/81317001287 Lot Numbers: 9527187 9528578 9538081 9542801 9547114 9561195 9567890 9559141 9595692 9597741 9615898 9619996 3501680/81317001294 Lot Numbers: 9530517 9545545 9562724 9584036 9585573 9615518 3501685/81317001300 Lot Numbers: 9541786 9546779 9555187 9574051 9616933 3501690/81317001317 Lot Numbers: 9543357 9547972 9602499 9602765 3501695/81317001324 Lot Numbers: 9544816 9552232 9563943 3502200/81317001355 Lot Numbers: 9532948 9550672 9607487 9611604 3502225/81317001362 Lot Numbers: 9550484 9553670 9595693 9596802 9596397 9598144 3502250/81317001379 Lot Numbers: 9535133 9539276 9551037 9555185 9547973 9550165 9584310 9586121 9604456 9599498 3502275/81317001386 Lot Numbers: 9530516 9533839 9535387 9541225 9550674 9547975 9576452 9576296 9576970 9578064 9608063 9608403 9608792 9612273 3502300/81317001393 Lot Numbers: 9530520 9535778 9536100 9541463 9546473 9561861 9563096 9564279 9565713 9564913 9569248 9589073 9589650 9592613 9592326 9606471 9614988 9615519 9629493 3502325/81317001409 Lot Numbers: 9526975 9528017 9528840 9529386 9530916 9541788 9557442 9555926 9569687 9570166 9571639 9570470 9573063 9578066 9576684 9577401 9596800 9597739 9615895 3502350/81317001416 Lot Numbers: 9530518 9535773 9533290 9535131 9536098 9541227 9546471 9552229 9553109 9556177 9555924 9573300 9570168 9570472 9571641 9572393 9587065 9587328 9589652 9591673 9594299 9606470 9614773 9614987 9610033 9608402 9614989 3502375/81317001423 Lot Numbers: 9544817 9546175 9546177 9550163 9556606 9554350 9555922 9556604 9553338 9567249 9568915 9569689 9584308 9585572 9598142 9599496 9600886 9608064 9625685 9624985 3502400/81317001430 Lot Numbers: 9529875 9538082 9541466 9541784 9545544 9549491 9554347 9563941 9564916 9562722 9592611 9615896 9616495 9617818 3502425/81317001447 Lot Numbers: 9530519 9534033 9538572 9543627 9551034 9559144 9559516 9563098 9567889 9611044 9611600 9612274 9614477 9632676 3502450/81317001454 Lot Numbers: 9531110 9543358 9546178 9553668 9558850 9568917 9569245 9571293 9571640 9570473 9573298 9602500 9603190 9606468 9611602 3502475/81317001461 Lot Numbers: 9540917 9537341 9554349 9567891 9569247 9602497 9603192 9608794 3502500/81317001478 Lot Numbers: 9538080 9543990 9547112 9558851 9558853 9559518 9589651 9590028 9594298 9608795 9610037 9606469 9626607 3502550/81317001485 Lot Numbers: 9532946 9553111 9556175 9557444 9594296 9595426 9596092 9612272 9616497 3502600/81317001492 Lot Numbers: 9535385 9583792 9586122 9587326 9612275 9616499 3502650/81317001508 Lot Numbers: 9538083 9551039 9614479 9615517 3502700/81317001515 Lot Numbers: 9567892 9586783 9588332 9620460 3502750/81317001522 Lot Numbers: 9573064 9576297 9574860 3502800/81317001539 Lot Numbers: 9528841 9525967 9528839 9527436 9550486 9561863 9563939 9565271 9566958 9565269 9564915 9571295 9575830 9630358 9629166 3503210/81317001584 Lot Numbers: 9567251 9595691 3503230/81317001591 Lot Number: 9574052 3503250/81317001607 Lot Numbers: 9545546 9565270 9591675 9608404 9610036 9610034 3503270/81317001614 Lot Numbers: 9541783 9558224 9555925 9611048 9613076 3503290/81317001621 Lot Numbers: 9530727 9541462 9543989 9563095 9561862 9565714 9562723 9559881 3503310/81317001638 Lot Numbers: 9527434 9543628 9538573 9563942 9529385 9582571 9584035 9590027 9602498 9602766 3503330/81317001645 Lot Numbers: 9529113 9529874 9532947 9528015 9541228 9536101 9542800 9552231 9561194 9558852 9559517 9559142 9578299 9580873 9582861 9580875 9582183 9584037 9590273 9588333 9586784 9587066 9616932 9617100 3503380/81317001652 Lot Numbers: 9533838 9530728 9534031 9535776 9540918 9544818 9546778 9550… (truncated, 6220 characters total — see the official FDA record for the full value)
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2021

SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; SC 1409/PGI Supercore 14GA x 9CM; SC 1609/PGI Supercore 16GA x 9CM; SC 1806/PGI Supercore 18GA x 6CM;

Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.

ALL 50 STATES
Full report

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

Recall #:
88814
Lot/product code:
REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; Lot Numbers: 11364350 11365643 11368388 11371872 11374998 11376772 11378864 11382837 11385962 11389848 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; Lot Numbers: 11368389; 11376773; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; Lot Numbers: 11362716; 11363320; 11365935; 11377634; 11381340; 11384192; 11388461; 11388552; 11389139; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; Lot Numbers: 11361702; 11365788; 11371012; 11374235; 11376598; 11379722; 11382768; 11383890; 11388656; 11389138; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; Lot Numbers: 11362759; 11363229; 11364420; 11367439; 11370106; 11372917; 11376074; 11377430; 11378217; 11383193; 11383785; 11384243; 11387238; 11388864; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; Lot Numbers: 11370107; 11375663; 11377819; 11382602; 11385139; 11385965; 11389140; 11390503; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; Lot Numbers: 11372225; 11374410; 11377431; 11384193; 11388505; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; Lot Numbers: 11374411; 11378865; 11383280; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; Lot Numbers: 11366252 11367440; 11376374; 11377820; 11381387; 11385960; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; Lot Numbers: 11366253; 11380018; 11388893; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; Lot Numbers: 11369916; 11378293; 11383587; 11387065; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; Lot Numbers: 11377967; 11382843; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; Lot Numbers: 11364421; 11367443; 11374684; 11379724; 11385966; 11388551; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; Lot Numbers: 11382845; 11388550; 11390251; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; Lot Numbers: 11361701; 11364247; 11367445; 11372366; 11374807; 11378687; 11383192; 11383784; 11388286; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; Lot Numbers: 11371404; 11373084; 11377636; 11380993; 11383194; 11383195; 11387400; 11387833; 11390504; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; Lot Numbers: 11366315; 11372227; 11377432; 11381193; 11382998; 11384716; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; Lot Numbers: 11367446; 11370574; 11375664; 11380589; 11381572; 11388507; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; Lot Numbers: 11368750; 11371876; 11372228; 11376375; 11377429; 11380104; 11384717; 11387148; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; Lot Numbers: 11362655; 11363516; 11372322; 11378295; 11380103; 11382884; 11387584; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; Lot Numbers: 11371356; 11382375; 11389615; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; Lot Number: 11371357; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; Lot Number: 11371359; SC 1409/PGI Supercore 14GA x 9CM; Lot Numbers: 11370550; 11384881; SC 1609/PGI Supercore 16GA x 9CM; Lot Number: 11370552; SC 1806/PGI Supercore 18GA x 6CM; Lot Numbers: 11375600; 11364469;
Recalling firm:
Argon Medical Devices, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 5, 2021

Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs

ALL 50 STATES
Full report

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

Recall #:
88870
Lot/product code:
Serial Numbers: 15916 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103301 103170 103223 103225 103247 15939 103313 103315 100413 100414 100417 100402 14612 14613 101016 101017 101019 101020 101022 101029 101031 101032 101036 18903 15945 15946 103359 15931 100263 103424 15953 103274 15941 15942 103319 103320 103321 103323 103325 103328 103330 103333 103334 103335 103344 100216 103337 15514 15515 100154 100156 100157 14803 14804 18502 15544 15545 100416 102008 103413 15561 101082 101083 101084 18902 14603 100208 100209 102138 103437 15560 101090 102019 102021 102025 102029 15559 101088 15819 15820 102145 102147 103160 15539 100346 100349 103314 102199 15830 102323 102324 102325 15832 15833 103079 122042 123004 15005 15147 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 122006 122026 102214 102216 102219 102222 102272 101096 102181 102242 102068 102069 102078 102080 102093 102097 15828 15829 102221 103123 103124 103131 100163 100165 15135 15136 100306 100309 15552 15553 101045 101052 101053 101054 101056 101059 101063 101064 103300 15564 15565 101099 101100 101101 15556 15557 101060 101068 101069 101070 101071 101072 103265 14602 100064 15546 14611 100422 14906 103307 103312 103019 10654 11657 14122 14123 103331 103362 103393 103402 103419 103252 103261 103267 103269 103270 103276 103277 103280 103281 103022 100279 103381 15543 15551 100408 100410 100411 100412 101043 102162 122029 103194 103145 103148 103152 15920 15537 15538 100345 123047 15836 15837 102285 102286 102338 102183 15943 15948 103345 103368 103415 103416 123053 15123 103245 103249 103250 103264 15949 15904 103080 103082 103086 103088 103089 103090 15530 100231 103290 15804 102030 102031 102304 101094 18600 15547 15548 101008 101093 15821 15523 100175 100176 102226 101097 15935 15936 103306 103341 15909 102269 102273 102276 102278 102279 103114 14809 14810 102283 15823 15824 102193 15803 15809 15506 15507 100070 100071 100074 102155 102157 15902 15903 103040 103042 14312 103039 15009 102174 102182 15813 15814 103130 103200 103234 103053 14900 103116 103117 103119 103288 18900 18901 14902 15927 15928 14802 15901 103008 103216 102237 103189 103208 15541 100391 15536 102010 15841 15842 102295 102296 102302 18099 100006 18098 14299 100005 10731 15524 15525 100184 15950 103352 122011 102274 14905 103283 15937 15938 103308 103310 15925 15926 103115 103244 103246 103014 15923 15924 103242 101018 121014 15818 102143 102091 Expanded Recall 10/27/21 (36 units) Serial Numbers: 15915 103137 103144 103196 103198 15913 103166 103173 123021 103184 103177 103186 103199 103139 103168 102326 103167 103178 103161 103172 14120 103432 102328 15520 15522 102060 102062 15807 15806 102057 102049 102051 103431 101095 101089 15558
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 6, 2021

Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038

The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.

ALL 50 STATES
Full report

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

Recall #:
88865
Lot/product code:
UDI 00630414596754
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 7, 2021

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

Mislabeled product.

ALL 50 STATES
Full report

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

Recall #:
90281
Lot/product code:
Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767
Recalling firm:
SCIENCE & BIO MATERIALS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

ALL 50 STATES
Full report

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

Recall #:
88826
Lot/product code:
LOT#: 6000842, 6002045, 6011609, 6034238, 6040517, 6042907. UDI: " Primary: 00886158000594 " Secondary: 30886158000595 " Tertiary: 50886158000599
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

ALL 50 STATES
Full report

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

Recall #:
88826
Lot/product code:
Lot Number 6018382
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

ALL 50 STATES
Full report

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

Recall #:
88826
Lot/product code:
Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

ALL 50 STATES
Full report

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

Recall #:
88826
Lot/product code:
Lot Numbers 6032947 and 6033588 UDI: " Primary: 00886158019961 " Secondary: 30886158019962 " Tertiary: 50886158019966
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 11, 2021

Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property

ALL 50 STATES
Full report

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

Recall #:
89134
Lot/product code:
All units
Recalling firm:
Forbes Rehab Services Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 12, 2021

Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8); 12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3); 13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R); 14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8); 15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33); 16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17); 17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18); 18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24); 19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12); 20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7); 21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6); 22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6); 23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1); 24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4); 25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4); 26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6); 27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4); 28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12); 29. PERFUSION M337112Q 1/B (Model M337112Q); 30. PERFUSION M344130B 1/B (Model M344130B); 31. PERFUSION M392419C 1/B (Model M392419C); 32. PERFUSION M394213B 1/B (Model M394213B); 33. PERFUSION M394213C 1/B (Model M394213C); 34. PERFUSION M490124D 1/B (Model M490124D); 35. PERFUSION M491335A 1/B (Model M491335A); 36. PERFUSION M499709E 1/B (Model M499709E); 37. PERFUSION M960164F 1/B (Model M960164F); 38. PERFUSION M960165E 1/B (Model M960165E); 39. PERFUSION M960169E 1/B (Model M960169E); 40. PERFUSION M960462C 1/B (Model M960462C); 41. PERFUSION M960462D 1/B (Model M960462D); 42. PERFUSION M960463D 1/B (Model M960463D); 43. PERFUSION M960466D 1/B (Model M960466D); 44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3); 45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12); 46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5); 47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9); 48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);

Product is labeled as non-pyrogenic but endotoxin testing was not performed.

ALL 50 STATES
Full report

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

Recall #:
88932
Lot/product code:
Medtronic Perfusion Kits: 1. Model BB10Q85R, (a) GTIN 00763000343057, Lot Numbers: 219164410, 220219784, 220822136, 222227252; (b) GTIN 20763000343068, Lot Numbers: 219822381, 220104257 2. Model BB11C01R, GTIN 00763000312190, Lot Numbers: 218556144, 218790882, 219012584, 219586019 3. Model B7H95R22, GTIN 00763000250904, Lot Numbers: 219586008, 220075503, 220476338 4. Model BB7H95R25, GTIN 00763000451738, Lot Numbers: 221406421 5. Model BB7H99R22, GTIN 00763000250911, Lot Numbers: 219814395, 219886115, 220143946, 220257643, 220434398 6. Model BB7P46R4, GTIN 00643169380967, Lot Numbers: 218503747, 219975261, 220383910, 221017404, 221148797 7. Model BB7P48R4, GTIN 00643169379848, Lot Numbers: 219073386 8. Model BB7W03R8, GTIN 00643169990562, Lot Numbers: 219107651, 219491297, 221590546 9. Model BB7W80R7, GTIN 00763000344535, Lot Numbers: 219380830, 219600017, 222304697, 222400044 10. Model BB8B09R7, GTIN 00763000307189, Lot Numbers: 218613111 11. Model BB8B09R8, GTIN 00763000347574, Lot Numbers: 219291877, 219529760, 219663957, 220095395, 220476333, 221148863, 221765951, 222227240, 222469109 12. Model BB8D40R3, GTIN 00643169655461, Lot Numbers: 219220652, 219482298 13. Model BB8Q16R, GTIN 00643169549364, Lot Numbers: 218657286, 221451556 14. Model BB8V01R8, GTIN 00763000411312, Lot Numbers: 221267645 15. Model HY2V10R33, GTIN 00763000299835, Lot Numbers: 219165752, 220104314 16. Model HY3Z71R17, GTIN 00763000241551, Lot Numbers: 219073460 17. Model HY3Z71R18, GTIN 00763000353728, Lot Numbers: 219435852, 220219913, 220911962 18. Model HY4V00R24, GTIN 00763000082451, Lot Numbers: 219115980, 219436006, 219975242, 220383867 19. Model HY6X29R12, GTIN 00763000280833, Lot Numbers: 218912023, 219061258, 219061259, 219061260, 219390708, 220075525, 220075526, 220281424, 220434431 20. Model HY8L14R7, GTIN 00763000353360, Lot Numbers: 220075494 21. Model HY8P36R6, GTIN 00763000097165. Lot Numbers: 219291532 22. Model HY8V01R6, GTIN 00763000025465, Lot Numbers: 218557263, 218901885 23. Model HY9D36R1, GTIN 00643169855465, Lot Numbers: 219291881, 219291882, 219291883, 219682010, 220144062, 220144063, 220383952, 220383953, 220383954 24. Model HY9L07R4, GTIN 00763000093495, Lot Numbers: 219237962 25. Model HY9L80R4, GTIN 00763000092603, Lot Numbers: 220104289 26. Model HY9M47R6, GTIN 00763000175634, Lot Numbers: 219165837, 219165838, 219452417, 219452418, 220295056, 220295059 27. Model HY9N38R4, GTIN 00643169985148, Lot Numbers: 219061189, 219390629, 220383876, 220954138 28. Model HY9R26R12, GTIN 00763000317942, Lot Numbers: 218790663, 219343932, 219401495, 220337254, 220866450, 220866451 29. Model M337112Q, GTIN 00763000242824, Lot Numbers: 219983643, 219984266, 221053657, 221206757, 221452447, 221516971 30. Model M344130B, GTIN 00643169946415, Lot Numbers: 218419494, 218419495, 220815603, 220883905, 221971754 31. Model M392419C, GTIN 00763000343095, Lot Numbers: 219179139, 220224289, 220637117, 221383886 32. Model M394213B, GTIN 00643169546417, Lot Numbers: 218544365, 218544407 33. Model M394213C, GTIN 00763000446437, Lot Numbers: 221309293, 222084799 34. Model M490124D, GTIN 00763000527471, Lot Numbers: 222060635 35. Model M491335A, GTIN 00763000372187, Lot Numbers: 219712665, 220479358 36. Model M499709E, GTIN 00643169713420, Lot Numbers: 219495811 37. Model M960164F, GTIN 00763000300128, Lot Numbers: 218616224, 218616225, 219868444, 22280711 38. Model M960165E, GTIN 00763000139445, Lot Numbers: 218551983, 218728458, 218728459, 222107381 39. Model M960169E, GTIN 00763000139421, Lot Numbers: 218517966, 220900240, 222047414, 222410763 40. Model M960462C, GTIN 00643169957015, Lot Numbers: 218953465 41. Model M960462D, GTIN 00763000399344, Lot Numbers: 220172291 42. Model M960463D, GTIN 00763000234775. Lot Numbers: 218483662, 218517778, 218742946, 218742949, 220729353, 220801827, 220867180, 220950181, 221143520, 221618074, 221875985 43. Model M960466D, GTIN 00763000090494, Lot Numbers: 219874178 44. Model TL4K33R3, GTIN 00613994288622, Lot Numbers: 220197637 45. Model TL4K95R12, GTIN 00763000247867, Lot Numbers: 219061229, 220383926 46. Model TL6C91R5, GTIN 00643169343641, Lot Numbers: 219435870 47. Model TL6G48R9, GTIN 00763000367909, Lot Numbers: 220004241, 220004242, 220326313, 220911952, 220911998 48. Model TL7X09R3, GTIN 00643169455115, Lot Numbers: 219107641, 219107642, 221000547
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 12, 2021

Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1.

The processing of collected episode data may fail due to a software error.

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

Recall #:
88907
Lot/product code:
Application software lower than v5.0.0.
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled October 12, 2021

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

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

Recall #:
D-0092-2022
Lot/product code:
Lot #: 163935, Exp: 10/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

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

Recall #:
89104
Lot/product code:
RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615
Recalling firm:
Cook Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

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

Recall #:
88930
Lot/product code:
Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual

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

Recall #:
88849
Lot/product code:
Serial Numbers/UDI: G3024453 (01)04562122959278(11)191029(21)G3024453 G3024456 (01)04562122959278(11)191029(21)G3024456 G3042466 (01)04562122959278(11)191115(21)G3042466 G3042471 (01)04562122959278(11)191115(21)G3042471 G3042477 (01)04562122959278(11)191115(21)G3042477 G3042478 (01)04562122959278(11)191115(21)G3042478 G3042484 (01)04562122959278(11)191115(21)G3042484 G3042486 (01)04562122959278(11)191115(21)G3042486 G3042487 (01)04562122959278(11)191115(21)G3042487 G3042496 (01)04562122959278(11)191115(21)G3042496 G3042499 (01)04562122959278(11)191115(21)G3042499 G3042501 (01)04562122959278(11)191115(21)G3042501 G3042576 (01)04562122959278(11)191220(21)G3042576 G3042578 (01)04562122959278(11)191220(21)G3042578 G3042583 (01)04562122959278(11)191220(21)G3042583 G3042584 (01)04562122959278(11)191205(21)G3042584 G3042585 (01)04562122959278(11)191205(21)G3042585 G3042587 (01)04562122959278(11)191205(21)G3042587 G3042588 (01)04562122959278(11)191220(21)G3042588 G3082956 (01)04562122959278(11)200929(21)G3082956 G3085640 (01)04562122959278(11)200929(21)G3085640 G3085644 (01)04562122959278(11)200929(21)G3085644 G3095193 (01)04562122959278(11)201211(21)G3095193 G3095194 (01)04562122959278(11)201211(21)G3095194 G3095195 (01)04562122959278(11)201211(21)G3095195 G3095197 (01)04562122959278(11)201211(21)G3095197 G3095202 (01)04562122959278(11)201211(21)G3095202 G3095445 (01)04562122959278(11)201228(21)G3095445 G3111596 (01)04562122959278(11)210401(21)G3111596 G3111597 (01)04562122959278(11)210401(21)G3111597 G3111598 (01)04562122959278(11)210401(21)G3111598 G3111605 (01)04562122959278(11)210402(21)G3111605 G3111606 (01)04562122959278(11)210402(21)G3111606 G3114264 (01)04562122959278(11)210428(21)G3114264 G3114267 (01)04562122959278(11)210428(21)G3114267 G3114366 (01)04562122959278(11)210514(21)G3114366 G3114368 (01)04562122959278(11)210514(21)G3114368 G3114372 (01)04562122959278(11)210517(21)G3114372 G3114373 (01)04562122959278(11)210517(21)G3114373 G3114376 (01)04562122959278(11)210517(21)G3114376 G3114379 (01)04562122959278(11)210517(21)G3114379 G3114399 (01)04562122959278(11)210518(21)G3114399 G3114897 (01)04562122959278(11)210519(21)G3114897 G3114902 (01)04562122959278(11)210519(21)G3114902 G3118967 (01)04562122959278(11)210528(21)G3118967 G3118968 (01)04562122959278(11)210528(21)G3118968
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

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

Recall #:
88840
Lot/product code:
Serial Numbers/UDI: 20514657 (01)04562122958868(11)161220(21)20514657; 20659147 (01)04562122958868(11)20181124(21)20659147; 20659148 (01)04562122958868(11)20181124(21)20659148; 20659149 (01)04562122958868(11)20181124(21)20659149; 20659150 (01)04562122958868(11)20181124(21)20659150; 20659153 (01)04562122958868(11)20181126(21)20659153; 20659154 (01)04562122958868(11)20181126(21)20659154; 20659155 (01)04562122958868(11)20181126(21)20659155; 20659156 (01)04562122958868(11)20181126(21)20659156; 205G0225 (01)04562122958868(11)20170418(21)205G0225; 205G0226 (01)04562122958868(11)20170424(21)205G0226; 205P2146 (01)04562122958868(11)20170615(21)205P2146; 205P2147 (01)04562122958868(11)20170615(21)205P2147; 205P2148 (01)04562122958868(11)20170615(21)205P2148; 205P2149 (01)04562122958868(11)20170615(21)205P2149; 205Q0809 (01)04562122958868(11)20170707(21)205Q0809; 205Q0810 (01)04562122958868(11)20170707(21)205Q0810; 205Q0812 (01)04562122958868(11)20170707(21)205Q0812; 205Q0815 (01)04562122958868(11)20171006(21)205Q0815; 205T7139 (01)04562122958868(11)20171006(21)205T7139; 205T7143 (01)04562122958868(11)20171026(21)205T7143; 205V5544 (01)04562122958868(11)20171026(21)205V5544; 205V5545 (01)04562122958868(11)20171030(21)205V5545; 205V5547 (01)04562122958868(11)20171031(21)205V5547; 205V5548 (01)04562122958868(11)20171031(21)205V5548; G3005239 (01)04562122958868(11)20190308(21)G3005239; G3005240 (01)04562122958868(11)20190308(21)G3005240; G3025041 (01)04562122958868(11)20190603(21)G3025041; G3025042 (01)04562122958868(11)20190604(21)G3025042; G3025044 (01)04562122958868(11)20190605(21)G3025044; G3025045 (01)04562122958868(11)20190605(21)G3025045; G3025048 (01)04562122958868(11)20190606(21)G3025048; G3025049 (01)04562122958868(11)20190606(21)G3025049; G3037183 (01)04562122958868(11)20190624(21)G3037183; G3037184 (01)04562122958868(11)20190624(21)G3037184; G3037192 (01)04562122958868(11)20190709(21)G3037192; G3043580 (01)04562122958868(11)20190820(21)G3043580; G3043581 (01)04562122958868(11)20190820(21)G3043581; G3043582 (01)04562122958868(11)20190820(21)G3043582; G3052217 (01)04562122958868(11)20191016(21)G3052217; G3052218 (01)04562122958868(11)20191016(21)G3052218; G3052225 (01)04562122958868(11)20191202(21)G3052225; G3052234 (01)04562122958868(11)20200128(21)G3052234; G3052236 (01)04562122958868(11)20200109(21)G3052236; G3054831 (01)04562122958868(11)20200115(21)G3054831; G3054833 (01)04562122958868(11)20191212(21)G3054833; G3054840 (01)04562122958868(11)20200115(21)G3054840; G3080616 (01)04562122958868(11)20201215(21)G3080616; G3080617 (01)04562122958868(11)20201215(21)G3080617; G3106256 (01)04562122958868(11)20210413(21)G3106256; G3106258 (01)04562122958868(11)20210413(21)G3106258; G3111572 (01)04562122958868(11)20210413(21)G3111572; G3111573 (01)04562122958868(11)20210421(21)G3111573
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)