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Recalls affecting West Virginia

Data last updated: September 8, 2026 at 1:13 PM UTC

16,444 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 October 30, 2017

Discover VH/Millennium VG Nuclear Medicine Imaging System

A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.

ALL 50 STATES
Full report

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

Recall #:
81736
Lot/product code:
Serial Numbers: 10191 10571 10269 1078 10340 10541 1081 10237 10326 1538 10171 1039 1080 10316 10177 10156 10197 10539 10395 1058 1372 10189 1107 1132 10438 10359 10406 10547 10375 10534 10182 3874990 10139 10555 1141 10354 10338 1056 10481 1035 10210 10572 10281 10190 10179 10193 1016 10300 10501 10284 10446 1119 10146 1100 10178 10041 00000011278NU9 3003 1126 10235 1013 10263 10526 10488 10507 10165 36478041 10239 10398 1025 10143 10390 10260 10435 10422 10445 10222 10357 10218 1046 10491 10353 10180 10530 5004 10256 10288 10333 10516 10556 10379 UNKASM00109201 10462 10557 10195 10581 10468 10560 10463 1890 10417 10334 DUMFMI40849011 10323 10425 10270 10426 1101 10453 10343 10348 10533 10412 10405 10494 DUMFMI40849005 10414 10561 10553 10461 10103 10352 10346 10529 1123 10213 10248 10371 10474 10023 1069 10385 1835 1118 1831 10362 10387 10393 10366 10466 10579 10585 10605 1003 1006 1038 1027 10057 1091 1060 1073 1102 1106 10180 10187 10236 1116 10242 10292 10238 10241 10336 10389 10373 10467 10504 10525 10593 10586 10447 10603 10597 10563 10408 10386 10436 10479 10477 1112 10543 10545 10538 10596 10537 1085 1153 10399 1095 1149 1105 1145 10230 10552 10265 10416 10575 10521 10185 DUMFMI40849014 10567 10480 10433 1814 10312 10167 UNKASM00109204 40772394 10212 10508 10188 10364 10294 10279 10587 10582 UNKASM00109200 10282 10485 10457 10355 DUMFMI40849009 1076 10505 10431 10495 10600 10253 10320 10345 1144 10559 10527 10325 DUMFMI40849019 10360 10396 10606 10514 10522 10268 10206 10564 10328 10456 10486 10489 10342 10562 10589 10520 10368 10424 10434 10448 10240 10402 10487 10249 10403 10428 10531 10313 10397 10598 10450 10591 10483 1155 10303 10519 10550 10439 10363 10599 10548 10314 10297 10401 10250 10401 10121 10400 10540 10207 10194 10476 10584 10204 10595 10594 10570 10040 1289 10175 10164 10384 1010 1072 10146 10133 10449 10283 10410 10169 10276 1066 10209 10376 10381 10244 1756 10420 10332 10216 10454 10124 10158 0000D4360X4372 10374 10378 1021 1074 1042 10518 10224 10590 DUMFMI40849016 10475 10493 10339 10172 10568 10028 10392 10302 10576 10291 10174 10569
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2017

VariCam

A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.

ALL 50 STATES
Full report

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

Recall #:
81736
Lot/product code:
Serial Numbers: 0000000010-203 0000000010-191 000003100-1829 00008125-18-18 00000000010-15 00000000010-63 00008125-16-59 000000099-4-04 00000000010-31 00000000010-82 00008125-16-70 00008125-18-09 00008125-18-16 00000000017-64 10280 00000000010-30 000003681-1803 00000000018-24 000003100-1840 000003101-1502 000003100-1744 00000000017-36 00000000016-86 00000000017-31 1065 1998 1999 000008125-1630 1008 00000000017-20 00000000017-22 00000000017-23 1804 00000000030-14 00000000030-15 00000000010-37 00000000010-44 00000000010-55 00000000030-16 00000000018-39 1704 00000ICPO50612 1697 1696 000000163-1758 00000000018-23 00000000016-73 00000000030-04 00000000010-59 00000000018-22 000003100-1760 000003100-1743 0000000010-134 000003100-1719 343 000003100-1763 61061 00000000010-04 00000000030-11 1649 00000000010-67 00000000010-45 00000000017-27 00000000017-15
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2017

Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939180051870 (Material Description Innova-EU 5 x 180 x 75); b. H74939180061870 (Material Description Innova-EU 6 x 180 x 75); c. H74939180071870 (Material Description Innova-EU 7 x 180 x 75); d. H74939180071870 (Material Description Innova-EU 8 x 180 x 75); e. H74939181051830 (Material Description Innova-EU 5 x 180 x 130); f. H74939181061830 (Material Description Innova-EU 6 x 180 x 130); g. H74939181071830 (Material Description Innova-EU 7 x 180 x 130); h. H74939181081830 (Material Description Innova-EU 8 x 180 x 130); i. H74939259051830 (Material Description Innova-China 5 x 180 x 130); j. H74939259061830 (Material Description Innova-China 6 x 180 x 130); k. H74939259071830 (Material Description Innova-China 7 x 180 x 130); l. H74939259081830 (Material Description Innova-China 8 x 180 x 130); m. H74939259081870 (Material Description Innova-China 8 x 180 x 75); n.H74939293051830 (Material Description Innova 5 x 180 x 130); o. H74939293051870 (Material Description Innova 5 x 180 x 75); p. H74939293061830 (Material Description Innova 6 x 180 x 130); q. H74939293061870 (Material Description Innova 6 x 180 x 75); r. H74939293071830 (Material Description Innova 7 x 180 x 130); s. H74939293071870 (Material Description Innova 7 x 180 x 75); t. H74939293081830 (Material Description Innova 8 x 180 x 130); u. H74939293081870 (Material Description Innova 8 x 180 x 75);

Stent possibly unable to be fully released from the delivery system.

ALL 50 STATES
Full report

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

Recall #:
78587
Lot/product code:
a. Innova-EU 5 x 180 x 75 (Batch No. 17520924 18202150 18759183 19079259 19699151 19699152 19699153 19699154 19741583 19750952 19856648 19858137 20818430);  b. Innova-EU 6 x 180 x 75 (Batch No. 17620115 17692708 17855043 18018503 18061521 18074203 18202155 18255925 18353496 18412277 18478379 18751462 18920645 18931139 19021594 19342056 19394346 19426941 19644666 19741582 19946632 20197319 20495963 20818433 21239460 );  c. Innova-EU 7 x 180 x 75 (Batch No. 17612617 17832625 18082136 18394610 19750817 20314145);  d. Innova-EU 8 x 180 x 75 (Batch No. 17520931 18628352 20818435);  e. Innova-EU 5 x 180 x 130 (Batch No. 17379136 17515253 17643398 17796883 17884790 17928403 17999422 18028550 18065189 18193713 18242545 18320365 18412270 18505175 18572704 18754507 18924413 18937020 18945803 19048201 19129188 19264799 19406217 19469659 19654093 19728059 19770174 19858438 19907842 20042126 20109694 20127894 20205065 20260073 20313036 20405381 20427160 20482532 20557178 20642269 20788044 20980789 21091410 21153699 21239470);  f. Innova-EU 6 x 180 x 130 (Batch No. 17339472 17360205 17393388 17507373 17563587 17567306 17621181 17643722 17692709 17751231 17775135 17837622 17893341 17918022 17951215 17977931 18006854 18028547 18065191 18242554 18305612 18412278 18488248 18523620 18688894 18708475 18751464 18802815 18838475 18920656 18999958 19105369 19129190 19178742 19222890 19317120 19367656 19406219 19491632 19597808 19644663 19654080 19664965 19780796 19786768 19815613 19851783 19946633 19984995 20042120 20100778 20127896 20186867 20193387 20260077 20297197 20316561 20378797 20427172 20466862 20478643 20646353 20754062 20797639 20862259 20913445 20980791 21004779 21032769 21178771 21216860 21239475 21276391);  g. Innova-EU 7 x 180 x 130 (Batch No. 17351561 17422684 17524012 17662465 17832627 17860677 17916569 17959306 18010628 18028548 18242534 18242556 18320373 18412269 18530138 18592948 18682281 18708601 18785731 18838474 18923775 19021789 19079547 19129191 19178744 19212926 19238403 19317121 19394343 19465187 19693682 19750818 19844551 19907848 20013943 20089474 20199942 20303720 20316576 20413225 20597205 20616293 20685727 20793173 20913448 21096958 21135270 21216475 21250891);  h. Innova-EU 8 x 180 x 130 (Batch No. 17349971 17360218 17672512 17951214 18065192 18074216 18320379 19129192 19299435 19635495 19728402 19775531 19946636 20109698 20171185 20495967 20646355 20793176 20818437 21075729 21163790 21240950);  i. Innova-China 5 x 180 x 130 (Batch No. 17456003 17456004 17629285 17851466 18077817 18899799 19048094 19474494 19511479 20455112 20539787 20562445 20754066 21045500 21121559 21271047);  j. Innova-China 6 x 180 x 130 (Batch No. 17454410 17454411 17454412 17456007 17542769 17629280 17727197 17851471 17988287 19169697 19291890 19327248 20936472 21020803);  k. Innova-China 7 x 180 x 130 (Batch No. 17456009 17456010 17463352 17727483 19354376);  l. Innova-China 8 x 180 x 130 (Batch No. 17456013 17823505 21130830);  m. Innova-China 8 x 180 x 75 (Batch No. 19491836);  n. Innova 5 x 180 x 130 (Batch No. 18558414);  o. Innova 5 x 180 x 75 (Batch No. 18583366 18611575 18754514);  p. Innova 6 x 180 x 130 (Batch No. 18565240 18583363 18644031 18733070 18741089 18744848 18754518 18771910 18780329 18797248 18813744 18823218 18850635 18872987 18886683 18892198 18900363 18913810 18977667 18988346 19013254 19039706 19116474 19129194 19141572 19151411 19164783 19185695 19185696 19188063 19188064 19199363 19212932 19212933 19222885 19240144 19240152 19252774 19267183 19267184 19288822 19288823 19288824 19399366 19464898 19475060 19501338 19511461 19527257 19540740 19545787 19560851 19589364 19609498 19664968 19752067 20109864 20112178 20159642 20186873 20216044 20233666 20247011 20279930 20370769 20394773 20529709 20594722 20602686 20611981 20627806 20628410 20642280 20800467 21098041 21122201 21239472 21239478);  q. Innova 6 x 180 x 75 (Batch No. 18563662 18611780 18632059 18733071 18741090 18744849 18751309 18759188 18832543 18839009 18844736 18860228 18866635 18872988 18900364 18913805 18913815 18977668 18988347 19013255 19039707 19048089 19141573 19151412 19173253 19199364 19240153 19262043 19288825 19294325 19309204 19338270 19372772 19399367 19426947 19438864 19500739 19511465 19540552 20159643 20233667 20394774 20430591 20485381 20594723 20611982 20754075 20800468 21244560);  r. Innova 7 x 180 x 130 (Batch No. 18558405 18583034 18587957 18620266 18670462 18696465 18713419 18733074 18754519 18785736 18791864 18823243 18886686 18888437 18913807 18920778 18935052 18977677 19006945 19013288 19129197 19139329 19149499 19164785 19173248 19185690 19206077 19228860 19272466 19288833 19309209 19382430 19408968 19408969 19426954 19426955 19464890 19500738 19527254 19597803 19644373 20109866 20138146 20186874 20216046 20244727 20267929 20292468 20611983 20611984 21098798 21135264 21240956);  s. Innova 7 x 180 x 75 (Batch No. 18550162 18563667 18604196 18632052 18661523 18670463 18696466 18713940 18741084 1875… (truncated, 5497 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2017

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939293052030 (Material Description Innova 5 x 200 x 130); b. H74939293052070 (Material Description Innova 5 x 200 x 75); c. H74939293062030 (Material Description Innova 6 x 200 x 130); d. H74939293062070 (Material Description Innova 6 x 200 x 75); e. H74939293072030 (Material Description Innova 7 x 200 x 130); f. H74939293072070 (Material Description Innova 7 x 200 x 75); g. H74939293082030 (Material Description Innova 8 x 200 x 130); h. H74939293082070 (Material Description Innova 8 x 200 x 75)

Stent possibly unable to be fully released from the delivery system.

ALL 50 STATES
Full report

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

Recall #:
78587
Lot/product code:
a. Innova 5 x 200 x 130 (Batch No. 18095733, 18137885, 18233108, 18379812, 18362996, 18420576, 18404859, 18457350, 18478823, 18488703, 18519986, 18696468, 18670333, 18667082, 18756979, 18855752, 18844729, 18872178, 18886680, 18866631, 18892405, 18900294, 18951278, 19039704, 19064055, 19079251, 19111601, 19173251, 19206070, 19238815, 19231426, 19351863, 19309202, 19382422, 19367647, 19426956, 19483869, 19490837, 19501322, 19540549, 19540559, 19569664, 19641827, 19750808, 19742326, 19830060, 19844547, 19873365, 19907333, 19970577, 20014162, 20080095, 20096498, 20112175, 20186872, 20223208, 20216043, 20435880, 20151952, 20444934, 20439618, 20314154, 20336209, 20394072, 20608020, 20608137, 20607734, 20657170, 20420612, 20337854, 20450027, 20616298, 20777472, 20470018, 20672513, 20832034, 20876897, 20871401, 20728970, 20776633, 20851808, 20975844, 21020806, 21124105, 21045072, 21057925, 21091417, 21115593);  b. Innova 5 x 200 x 75 (Batch No. 18343796, 18115802, 18379813, 19013283, 21124110);  c. Innova 6 x 200 x 130 (Batch No. 18152540, 18137923, 18096697, 18119044, 18119040, 18115810, 18230863, 18108301, 18230864, 18211280, 18211281, 18245462, 18230637, 18230636, 18410450, 18428643, 18473268, 18283383, 18343799, 18439907, 18431333, 18368130, 18523235, 18519980, 18661526, 18488709, 18389662, 18498563, 18515152, 18446693, 18733063, 18759192, 18759189, 18766678, 19540741, 18791863, 18832544, 18792872, 18855754, 18860236, 18823216, 18866636, 18844738, 18892194, 18900365, 18870948, 18872541, 18878446, 18900381, 18888435, 18988348, 18961203, 19064043, 18945808, 19072771, 19111551, 19079253, 19151922, 19116475, 19164618, 19206072, 19226126, 19141574, 19245284, 19240145, 19288826, 19288832, 19309205, 19309206, 19367648, 19377502, 19408962, 19426948, 19389007, 19490838, 19511466, 19501332, 19517646, 19545788, 19555598, 19560848, 19569663, 19589370, 19584757, 19641826, 19635253, 19664685, 19654162, 19670616, 19709446, 19728413, 19699320, 19782868, 19693686, 19682956, 19682955, 19830064, 19873362, 19907334, 19905446, 19941738, 19942503, 19918783, 20013959, 19970579, 20014164, 20023939, 20109861, 20188996, 20080098, 20080097, 20188052, 20187538, 20080096, 20109863, 20112179, 20320562, 20830984, 20216045, 20183756, 20158213, 20433364, 20434473, 20233669, 20286988, 20233670, 20303729, 20342627, 20233668, 20607288, 20574727, 20607402, 20455108, 20368051, 20432603, 20511193, 20394775, 20594724, 20635843, 20776979, 20478648, 20821884, 20754076, 20758252, 20821886, 20800469, 20886809, 20825353, 20885852, 20938124, 20913156, 20950528, 20975845, 20997424, 21004412, 21119055, 21117395, 21058225, 21098042, 21071017, 21122202, 21145025, 21145024, 21219047, 21219242, 21219052);  d. Innova 6 x 200 x 75 (Batch No. 18389661, 18623249, 18870949, 18900366, 19161485, 19245285, 19918786, 20635844, 20862432, 21098043);  e. Innova 7 x 200 x 130 (Batch No. 18152541, 18099223, 18130828, 18113523, 18230638, 18217571, 18211282, 18186723, 18240225, 18168041, 18291418, 18339045, 18368242, 18283384, 18339044, 18316737, 18394605, 18385509, 18420569, 18313150, 18488713, 18921110, 18961213, 19072776, 19134318, 19173258, 19161488, 19206078, 19228862, 19255680, 19288830, 19309211, 19377507, 19327253, 19408970, 19436702, 19483875, 19491821, 19501423, 19527344, 19555961, 19545789, 19624864, 19659433, 19693528, 19670619, 19709445, 19830069, 19811429, 19742336, 19918785, 19907336, 19851529, 19974524, 19974523, 20080094, 20001802, 20109860, 20001803, 20188364, 20109862, 20177945, 20181650, 20210393, 20244728, 20321275, 20320380, 20286989, 20434033, 20267930, 20405389, 20381126, 20316570, 20574731, 20607286, 20352590, 20442151, 20466869, 20622461, 20655052, 20495971, 20518171, 20628127, 20777268, 20777261, 20820730, 20731022, 20833824, 20758256, 20886953, 20819295, 20856506, 20910181, 20937554, 21004415, 21119514, 20997428, 21119515, 21045505, 21103020, 21058247, 21138682, 21217652);  f. Innova 7 x 200 x 75 (Batch No. 18336507, 18598712, 18733075, 18802238, 18892409, 18999955, 19151414, 19245286, 19511477, 19569668, 19684652, 19811430, 20699739, 20729796, 20978808, 21122996);  g. Innova 8 x 200 x 130 (Batch No. 18211294, 18313156, 18385119, 18519981, 18583365, 18611781, 18733076, 18754584, 18780335, 18844724, 18977671, 19006855, 19048092, 19072779, 19188060, 19245289, 19304348, 19351866, 19454525, 19501424, 19624788, 19664694, 19684647, 19839023, 19782933, 20014160, 20080099, 20112342, 20216047, 20286991, 20439603, 20386608, 20655679, 20655677, 20329707, 20410534, 20655798, 20357647, 20997431, 21123358, 21123667);  h. Innova 8 x 200 x 75 (Batch No. 18115809, 18313157, 18877978, 19161490, 19624794, 19887625, 20410535, 20862411)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2017

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

Internal program testing shows that product may not reach the indicated expiration date.

ALL 50 STATES
Full report

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

Recall #:
79181
Lot/product code:
Product Code 1293254, Lot Code 1709228140
Recalling firm:
Wiener Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2017

Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.

The recalled lots have demonstrated unexpected false positive THC results.

ALL 50 STATES
Full report

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

Recall #:
78608
Lot/product code:
Lots 403111, 406741, 396588, 398577, 396587
Recalling firm:
Alere San Diego, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2017

Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.

Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.

ALL 50 STATES
Full report

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

Recall #:
78885
Lot/product code:
Serial Numbers:  152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
Recalling firm:
Carl Zeiss Metrology Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 20, 2017

Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.

ALL 50 STATES
Full report

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

Recall #:
80057
Lot/product code:
MODEL #(s):  453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375,  US1203010398, US1203010407, US1304000043, US1304000046,  US1224000050, US1550001470, US1251000063, US1109010070,  US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396,  US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478,  US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005,  US1231000060, US1537001268, US1537001272, US1537001276, US1537001277, US1537001280, US1537001338, US1202010174,  US1417000023, US1419000042, US1412000038, US1419000004,  US1419000023, US1419000052, US1424000010, US1424000018, US1431000027, US1239000034, US1550001491, US1338000001,  US1550001502, US1550001468, US1611001807, US1611001814,  US1611001826, US1611001831, US1611001850, US1248000004,  US1248000025, US1248000028, US1248000035, US1517000665,  US1517000671, US1517000680, US1443000225, US1724000551,  US1724000561, US1729000573, US1729000601, US1729000604,  US1311000065, US1407000058, US1334000037, US1224000027,  US1304000017, US1517000691, US1517000696, US1352000036, US1652000003, US1652000011, US1652000016, US1652000042, US1505000498, US1505000518, US1505000567, US1337000007, US1337000008, US1343000057, US1352000052, US1203010408,  US1511000639, US1534001157, US1534001158, US1534001163, US1534001165, US1534001167, US1534001171, US1534001220,  US1534001223, US1534001226, US1534001229, US1534001230,  US1534001232, US1534001233, US1534001237, US1537001259,  US1537001265, US1324000046, US1443000180, US1613001985, US1617002038, US1619002059, US1619002079, US1619002081, US1517000666, US1517000669, US1517000685, US1407000059, US1441000164, US1443000181, US1443000195, US1441000163,  US1502000477, US1529001080, US1224000020, US1231000023,  US1231000035, US1231000064, US1231000081, US1231000083,  US1234000001, US1234000004, US1234000006, US1234000055,  US1352000017, US1352000023, US1352000024, US1304000041, US1352000059, US1107010009, US1107010013, US1107010014, US1108010043, US1108010057, US1109010073, US1352000062, US1407000038, US1407000041, US1408000002, US1716000343,  US1716000344, US1716000345, US1720000353, US1720000354,  US1720000363, US1709000268, US1525000986, US1525000991,  US1529000995, US1529001027, US1529001033, US1529001068,  US1107010034, US1109010069, US1201010136, US1505000478,  US1505000511, US1505000513, US1505000546, US1343000092,  US1417000006, US1443000219, US1638002490, US1611001828,  US1611001832, US1611001848, US1611001863, US1505000508,  US1505000528, US1505000529, US1505000540, US1534001217,  US1720000386, US1720000407, US1720000409, US1720000416,  US1720000419, US1720000422, US1720000427, US1720000428, US1446000242, US1244000010, US1251000075, US1224000034, US1244000048, US1608001665, US1609001701, US1609001702, US1609001703, US1609001704, US1609001706, US1609001707,  US1609001708, US1609001709, US1609001712, US1609001714,  US1609001722, US1609001727, US1609001729, US1652000009,  US1652000025, US1652000037, US1652000045, US1652000052, US1652000062, US1652000064, US1652000066, US1248000057, US1331000025, US1331000053, US1331000063, US1331000050,  US1331000069, US1331000070, US1334000001, US1331000001, US1331000002, US1331000003, US1331000012, US1331000022, US1238000001, US1202010150, US1304000045, US1325000027, US1328000007, US1328000008, US1334000025, US1343000049, US1331000007, US1446000243, US1446000287, US1450000325 US1431000040, US1433000064, US1433000067, US1537001311, US1537001331, US1547001372, US1550001454, US1550001472, US1550001476, US1550001484, US1407000012, US1244000068, US1248000007, US1248000010, US1248000015, US1248000024, US1248000030, US1251000023, US1239000014, US1203010353, US1202010152, US1202010198, US1202010212, US1202010235, US1203010374, US1203010395, US1202010180, US1202010181,  US1202010184, US1202010185, US1202010187, US1202010190, US1202010192, US1202010195, US1107010004, US1248000031,  US1248000042, US1248000046, US1248000050, US1248000059,  US1502000401, US1502000409, US1502000427, US1502000431,  US1502000433, US1502000435, US1502000437, US1502000447,  US1502000449, US1502000452, US1438000148, US1505000480,  US1343000022, US1107010035, US1109010082, US1109010087,  US1109010091, US1109010100, US1505000499, US1505000541,  US1505000542, US1443000235, US1446000245 US1446000276 US1324000023, US1324000047, US1325000013, US1325000014, US1325000001, US1325000003, US1325000021, US1224000039, US1331000023, US1343000089, US1611001820, US16110018… (truncated, 14887 characters total — see the official FDA record for the full value)
Recalling firm:
Invivo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2017

CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells

A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.

ALL 50 STATES
Full report

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

Recall #:
80137
Lot/product code:
Versions 6.0.1 or 6.0.2
Recalling firm:
Cellavision AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE MRI SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L310
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ESSENTIO MRI SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L110
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ESSENTIO MRI DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L111
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L301
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L300
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ALTRUA 2 SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model S701
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ESSENTIO SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L100
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ESSENTIO DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L101
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

PROPONENT DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L201
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VISIONIST X4 CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U228
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

PROPONENT EL DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L221
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE MRI EL DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L331
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VISIONIST CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U225 and Model 226
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VALITUDE CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U125
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

PROPONENT VDD SL Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L209 - NOT APPROVED IN US
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VALITUDE X4 CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U128
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)