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Recalls affecting Vermont

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

16,253 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 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 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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 2, 2020

Philips Respironics V60 Ventilator Part Number 1053613 - 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 1053613 V60 Ventilator,Intl Opt: CFLEX,AVAPS,PP Serial numbers: 100029460 100086827 100106522 100125955 100173096 100173294 100173478 100173526 100173591 100173593 100173595 100174299 100174305 100174308 100190730 100252781 100252782 100252785 100304095 100304097 100304263 100304264 100304446 100304447 100304448 100304451 100304462 201022963 100190253 201024196 201025984 201025987 201025988 100176847 100176856 100252776 100315180 100315377 100315598 100315602 100315607 100315610 100315889 100350701 100361426 100363749 100370895 100375246 100044066 100074200 100074206 100074207 100085241 100085243 100085327 100102145 100102150 100102152 100102155 100114031 100118553 100118676 100118684 100119491 100120774 100138585 100138589 100146847 100146849 100147395 201008175 201008180 201008192 201008218 201008225 201008226 201013645 201013649 201013650 201014018 201014041 201014042 201014047 201031153 201031164 201031195 201031200 201031214 201031215 201031218 100039855 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10… (truncated, 21745 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 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 V680 Ventilator Part Number 850011 - 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: V680 Part Number: 850011 V680 Ventilator, Finished  Serial Numbers: 201009427 201009428 201009429 201009493 201009494 201009495 201009496 201009498 201009499 201009660 201009661 201009662 201009663 201009664 201009665 201009666 201009667 201009668 201009669 201009670 201009671 201009672 201009673 201009675 201009676 201009677 201009678 201009679 201009674 201008743 201008765 201008766 201008770 201008771 201008776 201008785 201008786 201008805 201009497 201008801 201008741 201008744 201008760 201008764 201008767 201008768 201008772 201008775 201008783 201008808 201008762 201008773 201008781 201008809 201008807 100124645 100124646 100125009 100125011 100125012 100125013 100125014 100125148 100125149 100125150 100125152 100125153 100125154 100125155 201008740 201008742 201008774 201008777 201008802 201008804 100125541 100125544 201008780 201008800 201008803 100125504 100125505 100125509 100125512 100125542 100125545 100125550 100125551 100125552 201008784 100125508 100125546 100125549 100125010 100125516 100125517 100125151 100125515 100125547 201008782 100125513 100125510 100129145 201010488 201010551 201010627 100129141 100129142 100129143 201010254 201010535 201010546 201010674 100126254 100129144 100134076 201010428 201010482 201010490 201010536 201010548 201010620 201010622 201010675 100125518 100129147 100134077 201010255 201010360 201010434 201010485 201010538 201010623 201011218 100125553 100129146 100129148 100134073 100134074 100134075 100134078 100134079 100134180 100134181 100134182 100134183 201010251 201010252 201010256 201010257 201010258 201010259 201010426 201010427 201010429 201010430 201010438 201010484 201010491 201010537 201010539 201010540 201010544 201010545 201010547 201010550 201010552 201010553 201010624 201010625 201010626 201011216 201011217 201011220 100134184 201010439 201010483 100134337 100135409 100125543 100134335 100135396 100135398 100135400 100135401 100135402 100135404 100135405 100135406 100135407 100135631 100135633 100135634 100135635 100135636 100135638 100135639 100135630 100135637 100135642 100135644 100135650 201011219 100135640 100135641 100135643 100135647 100135652 100135397 100135645 100135646 100135648 100135649 100135651 100135653 100135654 100135655 100137426 100137427 100137428 100137429 100137430 100137431 100137433 100137434 100137436 100137437 100137438 100137439 100137440 100137444 100137446 100137447 100137448 100137449 100137450 100138009 100138010 100138011 100138012 100138016 100138017 100138018 100138019 100138508 100138510 100135403 100135632 100137435 100137442 100137443 100137445 100138013  100138080 100138082 100138507 100137432 100137441 100138008 100138081 100138083 100138086 100138087 100138503 100138512 100138513 100138514 100138515 100138522 100138084 100138085 100138509 100138511 100138517 100138518 100138519 100138520 100138521 100138705 100138707 100138814 100138816 100138818 100138943 100139067  100138506 100138516    100138819 100138940 100138941 100138942 100139064 100139066 100139068 100139069 100139070 100139071 100139074 100139075 100139077 100139078 100139079 100139080 100139082 100139083 100139084 100139087 100140238 100140239 100140300 100140301 100140302 100140303 100140304 100140305 100140310 100140311 201012739 201013230 201013231 100139076 100139081 100139088 100140308 100140315 100140317 201012733 201012735  201013213 201013220 201013221 201013224 201013225 201013226 201013228 201013229 100138504 100139072 100139085 100140312 100140314 100140316 201012732 201012734 201012736 201013209 201013210 201013211 201013212 201013215 201013223 201013227 201013233 201013234 201013235 100139065 100139073 100140309 201012738 201013214 201013236 100139086 100140306 100140313 100142426 100142428 100142429 100142431 100142432 100142434 100142437 100142460 201013217 201013218 201013219 201013222 100135399 100135408     100142637 100142427 100142436 100142438 201013216 201013232 100142634 100142435 100142638 100142640 100142641 100142635 100142636 100142642 201013271 201013272 201013275 201013273 201013276 201013279 201013720 201013725 201013747 100142639 201013274 201013277 201014176 201014178 201014179 201014182 201014183 201014211 201014213 201013713 201013717 201013749 201013887 201014185 201014214 201013890 201014177 201014181 201014184 201014196 201014198 201014199 201014215 201014216 201014217 201014218 201014219 201013709 201013710 201013711 201013712 201013714 201013715 201013716 201013724 201013744 201013748 201013750 201013753 201013888 201013889 201013891 201013893 201014197 201014340 201014180 201014324 201014342 201014388 201014195 100146372 100146374 201014322 201014323 201014326 201014328 201014386 100146369 100146370 100146371 100146373 100146873 201014321 201014325 201014327 201014341 201014343 201014344 100147209 100146442 100146875 100146375 100146876 100147212 201014544 100147217 201014534 201014536 201014542 201014600 201014538 100147215 100146376 100146377 100146440 100146443 100146872 100147218 100147300 20101… (truncated, 33981 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 1053618 - 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: 1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS  Serial Numbers: 100019618 100019631 100019639 100019822 100019823 100019824 100019827 100019838 100019917 100019920 100019922 100019924 100019965 100019966 100019967 100019971 100019972 100020663 100020664 100020665 100020666 100022148 100023892 100023893 100023894 100023896 100023897 100023899 100023905 100023909 100023940 100023941 100023944 100023956 100023995 100023998 100024000 100024003 100024007 100024008 100024688 100025546 100025549 100026087 100026088 100026089 100026090 100026092 100026095 100026124 100027090 100027095 100027100 100027101 100027108 100027114 100027174 100027176 100027181 100027185 100027191 100027199 100027200 100027543 100027546 100027547 100027548 100027550 100027552 100030134 100030201 100030203 100030205 100030206 100030211 100030355 100031913 100031917 100031921 100031937 100031941 100031942 100032336 100032337 100032338 100032339 100032340 100032341 100032343 100032344 100032345 100032346 100032347 100032348 100032349 100032350 100032351 100032352 100032355 100032356 100032357 100032358 100032359 100032360 100032361 100032362 100032363 100032364 100032365 100032463 100033755 100033760 100033763 100033884 100033886 100033888 100033890 100033891 100033892 100033893 100033896 100033899 100033901 100033902 100033903 100033907 100033908 100033909 100033911 100035915 100036162 100036304 100036305 100038186 100038206 100039145 100039146 100039151 100039154 100039156 100039157 100039158 100039159 100039160 100039162 100039165 100039166 100039169 100039171 100039242 100039243 100039246 100039251 100039253 100039255 100039256 100039257 100039258 100039259 100039260 100039262 100039263 100039264 100039265 100039266 100039267 100039269 100039945 100043931 100043934 100043935 100043937 100043944 100043945 100043949 100043955 100043956 100043958 100044057 100044058 100044063 100044067 100044068 100044069 100044070 100044072 100044085 100044192 100044202 100044204 100044206 100044208 100044334 100044336 100044337 100044338 100044339 100044340 100044343 100044344 100044345 100044346 100044351 100044353 100046137 100046147 100046223 100046225 100046226 100046227 100046228 100046229 100046230 100046231 100046236 100046237 100046238 100046240 100046243 100046244 100046246 100046255 100046256 100046390 100046394 100046395 100046397 100046400 100046409 100046411 100046532 100046534 100046536 100046539 100046540 100046548 100046550 100046552 100046553 100046555 100046557 100046560 100046562 100046563 100046648 100046650 100046651 100046652 100046653 100046654 100046655 100046656 100046718 100046719 100046720 100046722 100046723 100046724 100046725 100046726 100046727 100046729 100046730 100046735 100046736 100046738 100046739 100046743 100046896 100046927 100046928 100047065 100050074 100050077 100050079 100050083 100050084 100050085 100050087 100050088 100050089 100050092 100050093 100050094 100050096 100050098 100050099 100050100 100050101 100050102 100050176 100050199 100050200 100050206 100050208 100050211 100050214 100050216 100050217 100050349 100050353 100050355 100050356 100050357 100050358 100050359 100050360 100050361 100050366 100050371 100050374 100050375 100050376 100050377 100050379 100050380 100050381 100050464 100050466 100050467 100050468 100050510 100050511 100050518 100052745 100052748 100052750 100052753 100053586 100053694 100053697 100053779 100053782 100053783 100053784 100054411 100054412 100054413 100054416 100054417 100054418 100054419 100054420 100054421 100054423 100054525 100054532 100054534 100054620 100054622 100054625 100054627 100054629 100054630 100054631 100054632 100054633 100054634 100054635 100054636 100054735 100054737 100054739 100054740 100054741 100054742 100054743 100054744 100054745 100054746 100054748 100054750 100054751 100054752 100054753 100054755 100054757 100054813 100054814 100054825 100055258 100055259 100055261 100055262 100055263 100055264 100055266 100055267 100055271 100055272 100055352 100055353 100055355 100055358 100055369 100055370 100055552 100055558 100055559 100055560 100055561 100055563 100055564 100055565 100055566 100055567 100055569 100055570 100055572 100055575 100055576 100055577 100055702 100055712 100055713 100055714 100055715 100055716 100055718 100057203 100057216 100057356 201001557 201001558 201001559 201001560 201001561 201001564 201001569 201001579 201001855 201001856 201001859 201001861 201001866 201001867 201001869 201001990 201001992 201001997 201002040 201002043 201002045 201002046 201002047 201002048 201002178 201002179 201002221 201002222 201002226 201002228 201002230 201002293 201002294 201002299 201002300 201002305 201002331 201002333 201002334 201002335 201002336 201002337 201002342 201002345 201002346 201002347 201002348 201002349 201002350 201002352 201002353 201002542 201002543 201002919 201003041 201003063 201003065 201003073 201003075 201003077 201003079 201003087 201003091 201003094 201003096 201003098 201003099 201003100 201003101 20… (truncated, 5427 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 R1053618 - 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: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS  Serial Numbers: 100039155 100054624 100054738
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 1076716 - 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: 1076716 V60 Ventilator, CHINA OPT: CFLEX, AVAPS  Serial Numbers: 100193935 100194169 100030124 100030335 100030359 100030360 100030761 100030762 100030763 100030764 100030766 100030767 100030768 100030769 100030770 100030771 100030773 100030775 100030776 100030777 100030779 100030782 100030783 100030784 100032461 100032686 100032687 100032688 100032689 100032690 100032691 100032692 100032695 100032697 100032698 100032701 100032702 100035773 100035778 100035779 100035896 100035897 100035898 100035899 100035900 100035901 100035902 100035903 100035904 100035907 100035909 100035910 100035911 100035913 100035914 100035918 100035919 100035926 100036047 100036302 100036306 100036307 100036310 100036311 100036313 100036314 100036316 100036317 100036320 100036432 100036433 100036434 100036439 100037365 100037366 100037367 100037368 100037369 100037370 100037371 100037372 100037373 100037374 100037375 100037376 100037377 100037378 100037379 100037380 100037382 100037383 100037384 100037385 100037386 100037387 100037388 100037389 100037390 100037391 100037392 100037393 100037394 100037395 100037541 100037542 100037548 100037551 100037559 100037561 100037562 100037563 100037564 100039784 100039789 100039973 100040077 100040088 100043091 100043304 100043306 100043307 100043308 100043309 100043310 100043311 100043312 100043318 100043320 100043321 100043941 100043942 100043943 100043946 100043947 100043950 100043953 100046144 100046153 100046155 100046158 100046160 100046161 100046162 100046163 100046546 100046745 100047058 100047068 100049056 100049057 100049058 100049059 100049060 100049061 100049062 100049063 100049064 100049065 100049068 100049069 100049070 100049072 100049076 100049077 100050076 100051086 100051087 100051090 100051091 100051092 100051093 100051094 100051095 100051096 100051097 100051098 100051320 100051321 100051322 100051323 100051324 100051325 100051326 100051327 100051328 100051329 100051330 100051332 100051333 100051334 100051335 100051336 100051337 100051338 100051339 100051340 100051341 100051342 100051343 100051344 100051345 100051346 100051347 100051348 100051349 100051965 100052401 100052403 100052407 100052411 100052413 100052414 100052415 100052416 100052417 100052524 100052525 100052526 100052527 100052528 100052529 100052530 100052531 100052532 100052533 100052534 100052535 100052536 100052537 100052538 100052747 100052841 100052843 100052853 100052942 100052943 100052948 100052952 100052953 100052954 100052955 100052956 100052957 100052958 100052959 100052960 100052961 100052962 100052963 100052964 100052965 100052966 100053047 100053048 100053049 100053051 100053052 100053053 100053054 100053055 100053056 100053057 100053058 100053059 100053060 100053061 100053062 100053063 100053065 100053066 100053067 100053068 100053069 100053071 100053072 100053073 100053074 100053075 100053581 100053582 100053583 100053584 100053585 100053587 100053588 100053589 100053590 100053591 100053592 100053593 100053595 100053597 100053599 100053601 100053678 100053681 100053683 100053687 100053689 100053690 100053691 100053693 100053695 100053778 100053787 100053789 100053790 100053791 100053792 100055717 100055808 100055809 100055810 100055811 100055812 100055813 100055814 100055816 100055817 100055818 100055819 100055820 100055821 100055822 100057204 100057207 100057208 100057209 100057210 100057211 100057212 100057215 100057352 100057379 100058322 100058323 100058324 100058325 100058326 100058327 100058328 100058329 100058330 100058331 100058332 100058333 100058334 100058335 100058336 100058337 100058338 100058339 100058340 100058341 100058473 100058474 100058475 100058476 100058477 100058478 100058479 100058480 100058481 100058482 100058483 100058484 100058485 100058486 100058488 100058492 100058558 100058560 100058564 100058567 100058569 100058570 100058571 100058833 100058834 100058836 100058838 100058841 100058912 100059167 100059170 100059171 100059247 100059250 100060392 100060393 100060405 100060415 100060585 100060591 100060593 100060594 100060597 100060599 100060600 100061623 100061624 100061628 100061630 100061631 100061632 100061633 100061634 100061643 100061644 100061647 100061648 100063165 100063172 100063173 100063174 100063175 100063176 100063178 100063179 100063271 100063272 100063273 100063274 100063275 100063276 100063277 100063278 100063279 100063280 100063281 100063282 100063283 100063284 100063285 100063286 100063287 100063288 100063290 100063291 100063292 100063294 100063297 100064513 100064514 100064515 100064516 100064517 100064518 100064519 100064520 100064521 100064522 100064523 100064534 100064564 100064569 100064573 100064668 100064671 100064672 100064673 100064674 100064675 100064676 100064677 100064698 100064699 100064703 100064720 100064721 100064722 100064831 100064832 100064833 100064835 100064836 100065341 100065497 100065499 100065508 100065509 100065511 100065515 100065591 100065592 100065598 100065600 100065602 100065605 100067434 100067452 1… (truncated, 102998 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 1053616 - 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: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100087733 100087738 100087932 100087999 100088155 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842 100029849 100030985 100031674 100033326 100033327 100033328 100033329 100033330 100033332 100033333 100033334 100033335 100033336 100033338 100033339 100033340 100033342 100033454 100034684 100034703 100035358 100035365 100035742 100035744 100035755 100037043 100037044 100037049 100037051 100037057 100037059 100037061 100037257 100038935 100038936 100038939 100040185 100042229 100042475 100043439 100043440 100044800 100044801 100047830 100048873 100049578 100049922 100050003 100050633 100050634 100050638 100050891 100052079 100052289 100052290 100052639 100052645 100053142 100053143 100053337 100053356 100053971 100055007 100056058 100056891 100056894 100058686 100058693 100058698 100063885 100064427 100064431 100064439 100064682 100064684 100064784 100064787 100065219 100066227 100071766 100072295 100079339 100079474 100080118 100080120 100080121 100080122 100080123 100080124 100080126 100080127 100081004 100084640 100091078 100095091 100095180 100095333 100095545 100095633 100095634 100096642 100096690 100096788 100096789 100097541 100097922 100097924 100097926 100097927 100104724 201001172 201001189 201001254 201001255 201001256 201001259 201001260 201001682 201001683 201001696 201001699 201001700 201001720 201001729 201001808 201001812 201001814 201001823 201001825 201001826 201001827 201001829 201001830 201001843 201001849 201001873 201001884 201001939 201001944 201002117 201002148 201002184 201002193 201002426 201002427 201002443 201002445 201002448 201002552 201002566 201002574 201002587 201002770 201002778 201002834 201002868 201002873 201002894 201002899 201002900 201003014 201003145 201003149 201003179 201003183 201003185 201003187 201003216 201003219 201003233 201003238 201003263 201003266 201003268 201003269 201003272 201003273 201006557 Amended 07/29/2021: US Products that Faceplates will be replaced Model: V60 Part Number: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842… (truncated, 6780 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 13-2201-5 - 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 08-4231-0 - 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 08-2201-5 - 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 08-2231-2 - 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 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 08-2301-3 - 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

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 08-2351-8 - 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 08-3231-1 - 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

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

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 08-3201-4 - 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 08-2251-0 - 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 08-3251-9 - 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)