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Recalls affecting Kentucky

Data last updated: September 9, 2026 at 1:18 PM UTC

16,694 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 November 2, 2020

Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Plus Part Number: 1138747 V60 Plus Ventilator, US Serial Numbers: 100360666 100363973 100365901 100365983 100365987 100366525 100366542 100367657 100367660 100367732 100370559 100371789 100371876 100371995 100372119 100372901 100372903 100373102 100373106 100373116 100373117 100374141 100374143 100374149 100374168 100374169 100374171 100374236 100374238 100374283 100374285 100374287 100374291 100374406 100374410 100374453 100374456 100374458 100374459 100376350 100376351 100377022 100377275 100377278 100377304 100377307 100377315 100377334 100378833 100378838 100379236 100379341 100379350 100379351 100379352 100379368 100379432 100379438 100379462 100379465 100380046 100380441 100381016 100381020 100381021 100381023 100381024 100381025 100381029 100381049 100382407 100382409 100382413 100382428 100382429 100382432 100382433 100382436 100382439 100382440 100382446 100382448 100382450 100382454 100382460 100382463 100382468 100382469 100382472 100382479 100382481 100382482 100382486 100382491 100382492 100382494 100382496 100382503 100382507 100382509 100382522 100382526 100382529 100382531 100382547 100382548 100384413 100384416 100384680 100384706 100384707 100384710 100384713 100384715 100384717 100384723 100384732 100384735 100384742 100384743 100384747 100384759 100384763 100385374 100385409 100385416 100385421 100385424 100385432 100385437 100385458 100385499 100386092 100386113 100386133 100386142 100386157 100386161 100386162 100386163 100386180 100386181 100386192 100386194 100386196 100386198 100386199 100386205 100386221 100386226 100389961 100389962 100389964 100389978 100389979 100390065 100392648 100392657 100392800 100392808 100392810 100392811 100392815 100392825 100392826 100392828 100392833 100392838 100392840 100392843 100392848 100392850 100392853 100392854 100392855 100392857 100392861 100392862 100392866 100392870 100392871 100392872 100392873 100392874 100392880 100392881 100392883 100392893 100392895 100392901 100392904 100392910 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100395715 100395716 100395717 100395718 100395719 100395800 100395801 100395802 100395803 100395804 100395805 100395806 100395807 100395808 100395809 100395810 100395994 100395995 100395996 100395997 100395998 100395999 100396000 100396001 100396002 100396003 100396004 100396005 100396006 100396007 100396008 100396009 100396010 100396011 100396012 100396013 100396014 100396015 100396016 100396018 100396019 100396020 100396021 100396022 100396023 100396116 100396117 100396118 100396119 100396121 100396122 100396123 100396124 100396125 100396126 100396127 100396128 100396129 100396130 100396132 100396133 100396134 100396136 100396138 100396139 100396140 100396142 100396144 100396145 100396147 100396148 100396150 100396151 100396152 100396154 100396155 100396156 100396157 100396158 100396159 100396162 100396163 100396164 100396165 100396166 100396167 100396168 100396169 100396170 100396171 100396172 100396173 100396174 100396175 100396176 100396177 100396178 100396521 100396522 100396523 100396524 100396525 100396526 100396528 100396529 100396530 100396531 100396534 100396536 100396537 100396538 100396539 100396563 100396564 100396565 100396566 100396568 100396569 100396570 100396571 100396572 100396573 100396574 100396576 100396577 100396578 100396579 100396587 100396588 100396589 100396591 100396594 100396596 100396597 100396599 100396600 100396601 100396742 100396743 100396744 100396756 100396758 100396759 100396760 100396761 100396762 100396763 100367642 100372347 100374144 100374170 100374457 100374460 100377281 100377293 100377305 100377310 100377311 100377314 100377316 100377324 100377327 100377329 100377330 100377331 100377332 100377336 100377337 100381027 100382403 100382408 100382431 100382434 100382435 100382441 100382442 100382443 100382444 100382445 100382447 100382477 100382515 100382524 100382525 100382527 100382535 100382536 100382538 100382539 100382543 100382546 100384517 100384518 100384748 100385393 100385399 100385403 100385411 100385412 100385414 10… (truncated, 50200 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: DU1053617 V60 Ventilator, US Demo Units Serial Numbers: 100002908 100002911 100002913 100002914 100002916 100002959 100003001 100003003 100003005 100003007 100003018 100003046 100003052 100003081 100003674 100003675 100003685 100003689 100003728 100003736 100003757 100003909 100003910 100003913 100003916 100003918 100003919 100004032 100004033 100004077 100004081 100004120 100004122 100004123 100004124 100004125 100004127 100004128 100004131 100004320 100004322 100004323 100004324 100004325 100004508 100004542 100004543 100004545 100004547 100004549 100004550 100004553 100004554 100004555 100004556 100004557 100004558 100004620 100004621 100004622 100004623 100004624 100004625 100004626 100004627 100004982 100004983 100004984 100004985 100004986 100004987 100004988 100004992 100004994 100004995 100004999 100005110 100005116 100005117 100005141 100005147 100005150 100005239 100005241 100005242 100005247 100005251 100005334 100005338 100005347 100005388 100005486 100005489 100005491 100005595 100005690 100005697 100005699 100005987 100006282 100006368 100006884 100006887 100006892 100006893 100006932 100006934 100007044 100007345 100007635 100007712 100008137 100008145 100008148 100008354 100008359 100008422 100008425 100008432 100008644 100008650 100008657 100008854 100008943 100008999 100009000 100009087 100009097 100009098 100009334 100009776 100009856 100009858 100009960 100009973 100010102 100010167 100010202 100010205 100010232 100010518 100011305 100011778 100012044 100012282 100012284 100012290 100012291 100012358 100012542 100012545 100012770 100012896 100012968 100013483 100013600 100013629 100013665 100013666 100013673 100013674 100013675 100015786 100016534 100017356 100024283 100024300 100025783 100025793 100025947 100026813 100026818 100026825 100026948 100027405 100027421 100027744 100029670 100029674 100029677 100029679 100029680 100029682 100029687 100029696 100029698 100029831 100029834 100029836 100029837 100029840 100029841 100029843 100029845 100029846 100029847 100029848 100029851 100029852 100029853 100029854 100029856 100029857 100029860 100030028 100030030 100030033 100030034 100031683 100032466 100032471 100032473 100032474 100032477 100032478 100032479 100032539 100033462 100034676 100034677 100034680 100034691 100034696 100034806 100034807 100034810 100034821 100035425 100035617 100035734 100035745 100035748 100035750 100035751 100035752 100035753 100035757 100035758 100037766 100037774 100037775 100038022 100038420 100038429 100038595 100038597 100038599 100038600 100038608 100038611 100038710 100038712 100038713 100038718 100038719 100038722 100038723 100038725 100038726 100038730 100038733 100039252 100040159 100040163 100040166 100040758 100040848 100040850 100040852 100040854 100040855 100040856 100041393 100041394 100042014 100042015 100042016 100042018 100042019 100042020 100042023 100042024 100042025 100042026 100042027 100042030 100042115 100043383 100043388 100043389 100043390 100043391 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201000055 201000065 201000067 201000078 201000079 201000096 201000097 201000098 201000099 201000100 201000128 201000129 201000130 201000131 201000132 201000133 201000134 201000135 201000145 201000146 201000147 201000148 201000150 201000152 201000153 201000154 201000155 201000156 201000175 201000176 201000196 201000198 201000200 201000201 201000202 201000220 201000297 201000298 201000311 201000312 201000313 201000314 201000315 201000316 201000330 201000331 201000333 201000334 201000337 201000338 201000339 201000340 201000341 201000343 201000380 201000381 201000383 201000384 201000385 201000491 201000494 201000496 201001638 201002012 201002131 201002137 201002138 201002139 201002460 201002461 201002462 201002480 201002556 201002557 201002565 201002571 201002590 201002591 201002597 201002629 201002647 201002651 201002663 201002785 201002802 201002967 201003277 201003279 100031561 Model: V60 Ventilator, Part Number U1053617 V60 Ventilator, USED ENGL OPT:CFLEX, AVAPS,PPV,AT+ Note: U10536… (truncated, 15952 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1137292 V60 Ventilator, Intl Opt CFLEX, AVAPS 3.00 SW  Serial Numbers: 100286055 100286057 100286203 100286204 100286207 100289426 100289690 100289701 100289702 100289703 100289704 100289711 100291365 100291472 100291487 100291842 100309654 100309725 100309726 100309728 100311169 100311171 100314702 100315038 100318590 100318593 100318613 100319271 100319286 100319296 100319298 100319300 100329969 100329972 100329979 100337251 100339218 100340917 100341273 100345558 100345603 100369688 100284364 100284366 100286200 100286201 100286202 100286206 100288337 100289430 100289495 100289498 100289684 100289700 100291197 100291363 100291364 100291370 100291468 100291473 100291474 100291724 100291732 100291825 100291833 100291837 100309647 100309649 100309653 100317131 100317280 100320643 100321695 100321704 100329980 100329985 100329990 100341375 100376390 100378223 100378238 100291839 100341895 100343575 100343606 100343657 100343665 100343671 100343688 100345123 100345523 100345524 100345525 100345549 100345562 100345600 100345601 100345615 100354424 100354462 100355897 100356203 100356210 100356213 100356261 100356269 100356285 100356293 100356296 100356305 100356768 100358348 100366950 100367148 100367154 100367160 100367182 100289100 100289422 100289423 100289424 100289425 100289427 100289428 100289431 100289433 100289434 100289436 100289437 100289438 100289480 100289481 100289482 100289485 100289492 100289496 100289680 100289686 100289697 100289698 100289699 100289705 100289706 100289707 100289712 100289713 100291367 100291450 100291464 100291465 100291467 100291469 100291470 100291475 100291477 100291479 100291481 100291482 100291483 100291484 100291485 100291486 100291725 100291726 100291727 100291728 100291729 100291731 100291734 100291735 100291736 100291738 100291829 100291831 100291832 100291834 100291838 100291844 100309579 100309648 100314677 100314683 100314696 100314698 100314699 100314700 100314701 100314703 100314704 100314705 100314706 100314707 100314708 100314709 100314876 100315600 100315894 100316065 100316066 100316905 100316906 100316909 100316910 100316912 100316913 100316914 100317126 100317130 100317132 100317135 100317264 100317269 100317271 100317272 100317273 100317275 100317277 100317278 100317281 100317283 100317284 100317285 100317383 100318591 100318592 100319274 100319290 100319292 100319294 100319295 100319299 100319772 100319773 100319781 100320640 100320650 100321697 100321700 100321701 100321705 100321713 100329968 100329971 100329977 100329978 100329981 100329983 100329986 100329987 100329988 100329991 100329992 100330120 100330122 100330124 100330126 100330128 100330129 100337250 100337253 100337254 100337255 100337256 100338661 100338974 100338976 100338977 100338979 100339025 100339026 100339029 100339030 100339033 100339035 100339038 100339039 100339040 100339041 100339042 100339043 100339044 100339200 100339202 100339203 100339204 100339205 100339206 100339211 100339215 100339216 100339217 100339219 100339885 100340360 100340362 100340363 100340913 100340914 100340916 100340918 100341049 100341051 100341058 100341121 100341122 100341123 100341169 100341266 100341278 100341362 100341367 100341368 100341369 100341371 100341381 100341869 100341879 100341883 100341884 100341886 100341888 100341907 100341996 100342532 100342535 100342542 100342549 100342550 100342553 100342554 100342557 100342560 100342562 100342563 100342567 100342568 100343106 100343518 100343520 100343527 100343536 100343542 100343545 100343546 100343550 100343552 100343554 100343556 100343557 100343564 100343565 100343571 100343573 100343574 100343577 100343579 100343580 100343581 100343582 100343583 100343585 100343586 100343587 100343588 100343589 100343591 100343592 100343594 100343598 100343599 100343600 100343601 100343605 100343610 100343611 100343614 100343615 100343617 100343626 100343631 100343639 100343649 100343652 100343658 100343663 100343664 100343666 100343669 100343680 100343683 100343684 100343690 100343703 100343704 100343705 100343710 100343711 100344136 100344232 100344234 100344371 100345113 100345118 100345119 100345343 100345501 100345504 100345505 100345506 100345507 100345508 100345509 100345510 100345511 100345512 100345513 100345514 100345515 100345516 100345519 100345521 100345522 100345526 100345527 100345528 100345529 100345530 100345531 100345532 100345533 100345534 100345535 100345536 100345537 100345538 100345540 100345541 100345542 100345543 100345545 100345546 100345547 100345551 100345552 100345553 100345555 100345560 100345561 100345563 100345565 100345567 100345568 100345569 100345572 100345574 100345576 100345578 100345579 100345580 100345582 100345584 100345587 100345590 100345595 100345596 100345599 100345602 100345604 100345605 100345606 100345610 100345611 100345613 100345614 100345616 100345619 100345620 100345621 100345622 100345625 100345626 100345848 100346935 100346937 100346941 100346942 100346944 100346945 100346947 100351158 10035… (truncated, 8434 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1053617 V60 Ventilator, English Opt: None Serial Numbers: 201000151 100109977 100090432 100091177 100091771 100092004 100092037 100113859 100008140 100009121 100066005 100067771 100068862 100068864 100068866 100229881 100229933 100229936 100244028 100244036 100244037 100342231 201013345 201030470 201030473 201030478 MX0000810 MX0000813 MX0000825 MX0000828 100002909 100002910 100002912 100002915 100002998 100002999 100003000 100003002 100003004 100003006 100003019 100003040 100003041 100003042 100003043 100003044 100003045 100003047 100003048 100003049 100003050 100003051 100003053 100003080 100003082 100003083 100003084 100003085 100003086 100003087 100003088 100003089 100003090 100003091 100003092 100003148 100003149 100003658 100003659 100003661 100003662 100003663 100003664 100003665 100003666 100003667 100003668 100003669 100003670 100003671 100003672 100003673 100003680 100003681 100003682 100003683 100003684 100003686 100003687 100003688 100003690 100003691 100003692 100003725 100003726 100003727 100003729 100003730 100003731 100003732 100003733 100003734 100003735 100003737 100003738 100003739 100003746 100003747 100003748 100003749 100003750 100003751 100003752 100003753 100003754 100003755 100003756 100003758 100003759 100003760 100003860 100003861 100003862 100003863 100003864 100003901 100003902 100003903 100003904 100003905 100003906 100003907 100003908 100003911 100003912 100003914 100003915 100003917 100004016 100004017 100004018 100004019 100004020 100004021 100004022 100004023 100004024 100004025 100004026 100004027 100004028 100004029 100004030 100004034 100004035 100004072 100004074 100004075 100004076 100004078 100004079 100004080 100004082 100004083 100004084 100004085 100004121 100004126 100004129 100004130 100004132 100004133 100004134 100004135 100004136 100004137 100004138 100004139 100004321 100004541 100004544 100004546 100004551 100004552 100004559 100004980 100004981 100004989 100004990 100004991 100004993 100004996 100004997 100004998 100005100 100005101 100005102 100005103 100005104 100005105 100005106 100005107 100005108 100005109 100005111 100005112 100005113 100005114 100005115 100005118 100005119 100005140 100005142 100005143 100005144 100005145 100005146 100005148 100005149 100005151 100005152 100005153 100005154 100005155 100005156 100005157 100005158 100005159 100005235 100005236 100005237 100005238 100005240 100005243 100005245 100005246 100005248 100005249 100005250 100005252 100005253 100005254 100005325 100005326 100005327 100005328 100005329 100005330 100005331 100005332 100005333 100005335 100005336 100005337 100005339 100005340 100005341 100005342 100005344 100005348 100005349 100005353 100005354 100005355 100005356 100005357 100005358 100005359 100005387 100005389 100005390 100005391 100005393 100005394 100005395 100005396 100005397 100005398 100005399 100005400 100005401 100005402 100005403 100005404 100005405 100005484 100005485 100005487 100005488 100005490 100005492 100005493 100005494 100005495 100005496 100005497 100005498 100005499 100005500 100005501 100005502 100005503 100005581 100005582 100005583 100005584 100005585 100005586 100005587 100005588 100005589 100005590 100005591 100005592 100005593 100005594 100005596 100005597 100005598 100005600 100005683 100005684 100005685 100005686 100005687 100005688 100005689 100005691 100005692 100005693 100005694 100005695 100005696 100005698 100005700 100005701 100005702 100005760 100005761 100005762 100005763 100005764 100005765 100005766 100006211 100006212 100006213 100006214 100006215 100006216 100006218 100006219 100006280 100006281 100006283 100006285 100006286 100006287 100006288 100006365 100006366 100006367 100006369 100006370 100006371 100006372 100006373 100006374 100006375 100006376 100006377 100006378 100006379 100006380 100006381 100006382 100006383 100006384 100006390 100006391 100006392 100006393 100006394 100006395 100006396 100006397 100006398 100006399 100006400 100006401 100006402 100006403 100006404 100006405 100006407 100006408 100006409 100006520 100006521 100006522 100006523 100006524 100006525 100006526 100006527 100006528 100006529 100006530 100006531 100006532 100006533 100006534 100006535 100006536 100006537 100006538 100006539 100006587 100006588 100006589 100006590 100006591 100006592 100006593 100006594 100006595 100006596 100006597 100006598 100006599 100006600 100006601 100006602 100006603 100006604 100006605 100006606 100006687 100006688 100006689 100006690 100006691 100006692 100006693 100006694 100006695 100006696 100006697 100006698 100006699 100006700 100006703 100006705 100006706 100006882 100006885 100006889 100006890 100006894 100006895 100006896 100006897 100006898 100006899 100006900 100006928 100006930 100006931 100006935 100006936 100006937 100006938 100006942 100006943 100006944 100006945 100006946 100006947 100007030 100007031 100007032 100007033 100007034 100007035 100007036 100007037 100007038 100007039 100007040 100007041 100007042 1000070… (truncated, 942803 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2020

EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.

This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.

ALL 50 STATES
Full report

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

Recall #:
86847
Lot/product code:
Serial numbers CU4.0-01062 CU4.0-01063 CU4.0-01066 CU4.0-01068 CU4.0-01069 CU4.0-01070 CU4.0-01072 CU4.0-01073 CU4.0-01074 CU4.0-01076 CU4.0-01078 CU4.0-01079 CU4.0-01081 CU4.0-01083 CU4.0-01084 CU4.0-01086 CU4.0-01088 CU4.0-01089 CU4.0-01090 CU4.0-01091 CU4.0-01093 CU4.0-01094 CU4.0-01095 CU4.0-01096 CU4.0-01097 CU4.0-01100 CU4.0-01101 CU4.0-01102 CU4.0-01103 CU4.0-01104 CU4.0-01106 CU4.0-01107 CU4.0-01108 CU4.0-01110 CU4.0-01113 CU4.0-01114 CU4.0-01115 CU4.0-01116 CU4.0-01117 CU4.0-01119 CU4.0-01121 CU4.0-01123 CU4.0-01124 CU4.0-01126 CU4.0-01127 CU4.0-01128 CU4.0-01129 CU4.0-01130 CU4.0-01131 CU4.0-01132 CU4.0-01133 CU4.0-01134 CU4.0-01135 CU4.0-01138 CU4.0-01141 CU4.0-01142 CU4.0-01143 CU4.0-01144 CU4.0-01146 CU4.0-01147 CU4.0-01149 CU4.0-01151 CU4.0-01152 CU4.0-01153 CU4.0-01154 CU4.0-01157 CU4.0-01158 CU4.0-01159 CU4.0-01160 CU4.0-01161 CU4.0-01162 CU4.0-01163 CU4.0-01164 CU4.0-01165 CU4.0-01166 CU4.0-01167 CU4.0-01170 CU4.0-01173 CU4.0-01174 CU4.0-01175 CU4.0-01176 CU4.0-01177 CU4.0-01178 CU4.0-01179 CU4.0-01185 CU4.0-01186 CU4.0-01191 CU4.0-01195 CU4.0-01198 CU4.0-01203 CU4.0-01205 CU4.0-01215 CU4.0-01231 CU4.0-01233 CU4.0-01234 CU4.0-01237 CU4.0-01239 CU4.0-01245 CU4.0-01248 CU4.0-01251 CU4.0-01252 CU4.0-01255 CU4.0-01268 CU4.0-01289 CU4.0-01292 CU4.0-01299
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2020

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Manufacturing error that may have resulted in a cathode component being not meeting quality requirements. All devices met final functional testing requirements.

ALL 50 STATES
Full report

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

Recall #:
90429
Lot/product code:
GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029  Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC034 20LXAC069 20NXAC040
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC038 20NXAC032
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC042
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC090 20NXAC044
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC031  Additional affected lots as of 3/17/21: 20NXAC004 20LXAC033 20NXAC003 20LXAC032
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20NXAC005 20LXAC098 20NXAC037 20NXAC039  Additional affected lots as of 3/17/21: 20NXAC008 20LXAC063
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC024 20LXAC072 20LXAC073 20LXAC085 20NXAC017 20NXAC030 20LXAC074 20LXAC023 20LXAC104  Additional affected lots as of 3/17/21: 20LXAC066 20LXAC089
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC048 20LXAC053 20LXAC047 20NXAC016 20LXAC094 20NXAC009 20LXAC049 20LXAC054 20NXAC025 20NXAC024  Additional Affected lots as of 3/17/21: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 20NXAC016
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20NXAC034
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC052  Additional affected lot as of 3/17/21: 20LXAC088
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC097  Additional affected lot as of 3/17/21: 20NXAC033
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC056 20LXAC057 20NXAC038 20LXAC041 20LXAC055  Additional affected lots as of 3/17/21: 20NXAC013 20NXAC035
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC061 20NXAC036 20LXAC062  Additional affected lots as of 3/17/21: 20LXAC099 20LXAC086 20NXAC014
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC043 20LXAC044 20LXAC045 20LXAC059 20LXAC060 20LXAC079 20LXAC095 20NXAC026  Additional lots as of 3/17/21: 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC011
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC032 20NXAC003
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC092 20NXAC006 20NXAC027
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2020

Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

ALL 50 STATES
Full report

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

Recall #:
86855
Lot/product code:
Lot Numbers: 20LXAC051
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)