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Recalls affecting Wisconsin

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

16,927 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 1076709 - 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: 1076709 V60 Ventilator, JAPAN OPT: CFLEX,AVAPS,AT+  Serial Numbers: 100058561 100058562 100058565 100058572 100058573 100058574 100058576 100058835 100058840 100058844 100058845 100058846 100058902 100058903 100058904 100058905 100058906 100058908 100058911 100058914 100058917 100058968 100058970 100058971 100058975 100058977 100058990 100058991 100058994 100058997 100058999 100059002 100059149 100059153 100059163 100059239 100059248 100060123 100060124 100060214 100060215 100060216 100060219 100060220 100060222 100060229 100060232 100060234 100060236 100060239 100060328 100060329 100060330 100060331 100060339 100060340 100060341 100060344 100060345 100060346 100060347 100060388 100060389 100060398 100060400 100060402 100060404 100060406 100060407 100060409 100060410 100060416 100060476 100060483 100060484 100060486 100060487 100060488 100060490 100060491 100060492 100060494 100060496 100064705 100064706 100064707 100064710 100064712 100064830 100064837 100065342 100065346 100065347 100065351 100065353 100065354 100065355 100065356 100065358 100065359 100065360 100065361 100065362 100067432 100067443 100067445 100067447 100067449 100067536 100068184 100068356 100068357 100069968 100070232 100070233 100070234 100070236 100070305 100070307 100070308 100070309 100070396 100070397 100070399 100070400 100070401 100070403 100070404 100070405 100070406 100070407 100070410 100070411 100070412 100070475 100070478 100070479 100070481 100070483 100070485 100070486 100070488 100070489 100070490 100070493 100070495 100070769 100070773 100070775 100070779 100070782 100070856 100070857 100070934 100070970 100070978 100071069 100071076 100071384 100071385 100071387 100071389 100071391 100071392 100071398 100072410 100072411 100072413 100072493 100072593 100072600 100072602 100072603 100072604 100072608 100072675 100072680 100072689 100072694 100074196 100074198 100074204 100074205 100074208 100075092 100075093 100075094 100075097 100075098 100075102 100075103 100075105 100075106 100075165 100075166 100075167 100075168 100075169 100075170 100075171 100075172 100075173 100075174 100075175 100075176 100075177 100075178 100075179 100075180 100075181 100075182 100075183 100075184 100075185 100075186 100075187 100075188 100075294 100075296 100075297 100075298 100075299 100075300 100075301 100075302 100075303 100075304 100075307 100075308 100075309 100075367 100075368 100075372 100075373 100075375 100075377 100075379 100075380 100075382 100078057 100078058 100078059 100078122 100078130 100078131 100078133 100078134 100078135 100078136 100078137 100078138 100078139 100078141 100078142 100078143 100078144 100078146 100078147 100078148 100078149 100078150 100078151 100078152 100078153 100078154 100078155 100078260 100078261 100078262 100078263 100078264 100078265 100078267 100078268 100078270 100078271 100078272 100078273 100078274 100078275 100078276 100078299 100078300 100078301 100078303 100078304 100078305 100078306 100078307 100078308 100078310 100078311 100078312 100078314 100078315 100078316 100078317 100078361 100078363 100078373 100078375 100078376 100078377 100078378 100078380 100078381 100079713 100080234 100080235 100080238 100080270 100080272 100080273 100080274 100080278 100080279 100080280 100080283 100080284 100080287 100080288 100080293 100080296 100080538 100080539 100080646 100080648 100080655 100080703 100080705 100080707 100080710 100080715 100080719 100080720 100080730 100080732 100080735 100080737 100080851 100083533 100083565 100083602 100083812 100083814 100083818 100083826 100083827 100083829 100084956 100084958 100084959 100085081 100085083 100085088 100085091 100085094 100085096 100085097 100085098 100085251 100085335 100085341 100085382 100085384 100085390 100085391 100085392 100085393 100085394 100085396 100085400 100085402 100085403 100085404 100085489 100086237 100086889 100086895 100086899 100086903 100087014 100087015 100087018 100087024 100087026 100087030 100087031 100087048 100087051 100087055 100087056 100087160 100087341 100087355 100087359 100087461 100087467 100087469 100087476 100087480 100087481 100087483 100087486 100087601 100087605 100087610 100087615 100087686 100087690 100087694 100087700 100090529 100090530 100090533 100090534 100090535 100090537 100090538 100090539 100090540 100090541 100090542 100090543 100090544 100090546 100090548 100090549 100090551 100090554 100090555 100090556 100090653 100090655 100090656 100090657 100090659 100090660 100090661 100090662 100090663 100090664 100090666 100090669 100090671 100090673 100090675 100090676 100090678 100090679 100090783 100090785 100090790 100090791 100090795 100090802 100090806 100090807 100090912 100090913 100090915 100090918 100090920 100091021 100091261 100091273 100091377 100091378 100091379 100091394 100091397 100091399 100091403 100091720 100091722 100091723 100091724 100091726 100091728 100091729 100091730 100091732 100091735 100091737 100091738 100091739 100091743 100091745 100091818 100091841 10009184… (truncated, 37611 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 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 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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 R1076709 - 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: R1076709 V60 Ventilator, JAPAN OPT: CFLEX,AVAPS,AT+  Serial Numbers: 100065352 100065365 100065371 100065487 100065493 100067423 100067425 100067428 100067431 100067451 100068214 100069518 100070301 100070306 100070398 100070476 100070491 100070492 100070768 100070774 100070776 100070777 100070778 100070780 100070781 100070859 100070862 100070865 100070921 100070922 100070924 100070928 100070929 100070930 100070935 100070966 100070969 100070973 100070976 100070981 100071071 100071073 100071077 100071123 100071461 100071510 100071511 100072415 100072417 100072418 100072499 100072570 100072606 100072607 100072673 100072676 100072679 100072684 100072685 100072688 100072690 100072695 100074195 100075099 100075100 100075104 100075189 100075293 100075312 100075381 100078120 100078132 100078140 100078145 100078266 100078302 100078313 100078362 100078365 100078366 100078372 100079387 100080231 100080233 100080236 100080237 100080239 100080271 100080275 100080276 100080277 100080282 100080285 100080290 100080291 100080292 100080294 100080295 100080297 100080298 100080421 100080422 100080423 100080424 100080425 100080427 100080428 100080429 100080430 100080528 100080529 100080530 100080532 100080533 100080535 100080536 100080537 100080540 100080541 100080542 100080543 100080544 100080545 100080547 100080552 100080553 100080563 100080642 100080643 100080644 100080647 100080650 100080651 100080652 100080653 100080654 100080657 100080658 100080659 100080704 100080706 100080708 100080711 100080713 100080716 100080717 100080721 100080722 100080723 100080724 100080725 100080726 100080729 100080731 100080733 100080734 100080736 100080740 100080840 100080841 100080843 100080845 100080846 100080847 100080849 100080850 100080852 100081698 100083532 100083534 100083537 100083538 100083539 100083561 100083563 100083564 100083567 100083569 100083577 100083601 100083603 100083811 100083813 100083816 100083817 100083821 100083822 100083823 100083824 100083825 100083828 100083830 100083832 100083833 100083920 100083921 100083922 100083923 100083924 100083925 100083926 100083927 100083929 100083930 100084955 100084957 100085084 100085086 100085087 100085089 100085090 100085092 100085095 100085242 100085245 100085248 100085249 100085250 100085253 100085322 100085323 100085324 100085325 100085326 100085328 100085329 100085331 100085332 100085334 100085336 100085337 100085338 100085339 100085380 100085381 100085383 100085385 100085386 100085387 100085388 100085395 100085397 100085480 100085482 100085484 100085485 100085486 100085487 100085488 100086236 100086783 100086891 100086896 100086902 100087025 100087028 100087049 100087050 100087052 100087093 100087095 100087097 100087103 100087104 100087172 100087344 100087350 100087351 100087352 100087353 100087354 100087357 100087358 100087462 100087463 100087464 100087465 100087468 100087471 100087472 100087474 100087475 100087477 100087478 100087482 100087484 100087488 100087489 100087602 100087607 100087608 100087609 100087612 100087613 100087616 100087617 100087682 100087683 100087684 100087685 100087691 100087693 100087695 100087696 100087697 100087698 100087699 100088046 100088054 100088055 100088059 100088060 100088429 100088432 100088433 100088434 100088435 100088437 100088438 100088439 100088859 100089023 100089024 100089025 100089026 100089027 100089028 100089029 100089030 100089031 100089032 100089120 100089121 100089123 100089124 100089125 100089126 100089128 100089129 100089130 100089132 100089133 100089134 100089135 100089136 100089138 100089140 100089141 100089142 100089143 100089144 100089145 100089146 100089147 100089148 100089260 100089261 100089262 100089263 100089264 100089266 100089267 100089268 100089270 100089271 100089272 100089274 100089275 100089276 100089277 100089278 100089279 100089280 100089437 100089438 100089440 100089441 100089443 100089444 100089445 100089446 100089447 100089448 100089450 100089451 100089459 100089460 100089462 100089463 100089464 100089802 100089803 100089804 100090135 100090531 100090545 100090547 100090550 100090552 100090553 100090557 100090652 100090654 100090658 100090665 100090668 100090670 100090672 100090674 100090677 100090680 100090681 100090778 100090779 100090781 100090782 100090784 100090786 100090787 100090788 100090789 100090792 100090794 100090796 100090797 100090798 100090799 100090800 100090801 100090803 100090804 100090805 100090914 100090917 100090919 100090922 100090926 100090927 100090928 100090929 100090930 100091265 100091390 100091393 100091398 100091400 100091402 100091404 100091405 100091721 100091725 100091727 100091731 100091733 100091734 100091736 100091740 100091741 100091742 100091744 100091746 100091819 100091840 100091844 100091846 100091850 100091856 100091861 100091862 100091865 100091866 100091867 100091918 100091919 100100747 100100850 100100995 100100997 100100998 100100999 100101056 100101060 100101062 100101063 100101066 100101067 100101074 100101396 100101400 100101402 1001014… (truncated, 32222 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 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 Plus Ventilator Part Number 1137276 - 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: 1137276 V60 Plus Ventilator, International  Serial Numbers: 100341890 100341897 100343602 100343674 100345138 100345145 100345148 100352752 100352754 100354448 100354454 100354464 100354470 100354838 100354875 100357792 100358141 100358158 100358355 100359515 100381237 100381430 100381436 100381765 100381835 100381850 100384222 100384818 100384821 100384875 100384878 100384903 100387138 100387261 100387407 100387412 100387557 100387860 100387941 100387953 100388063 100388068 100388092 100388630 100388634 100388640 100388641 100388649 100388676 201040204 201040216 100345306 100345307 100346866 100346876 100346889 100346894 100346895 100346896 100346898 100346901 100346907 100346908 100346909 100346910 100346911 100346913 100348081 100348085 100348140 100348146 100352062 100355386 100355900 100355923 100356012 100356258 100356302 100356303 100360343 100360364 100360378 100361206 100361563 100361576 100362006 100362051 100364563 100369571 100369619 100369692 100369705 100369912 100375136 100375594 100375911 100375912 100378897 100378926 100378928 100378931 100378932 100378934 100378937 100297858 100298767 100298799 100298928 100298929 100300520 100302008 100302012 100304689 100304697 100304701 100305136 100305821 100306638 100309643 100310997 100311467 100311473 100311480 100314877 100320637 100327540 100327543 100327548 100336899 100337246 100346856 100346858 100348113 100348114 100348445 100350151 100350153 100352753 100352806 100352809 100352829 100354067 100354070 100354076 100354458 100354867 100355162 100355880 100355911 100355917 100355920 100356279 100358146 100359620 100359623 100360200 100361432 100361971 100362036 100362065 100362515 100362567 100362728 100363719 100363755 100363759 100363798 100364540 100365111 100365141 100365653 100367161 100368606 100371204 100371644 100376389 100378064 100378069 100378077 100378215 100378278 100378301 100378302 100378305 100378538 100378665 100378679 100378680 100378681 100378686 100378993 100379006 100380659 100380822 100380929 100380930 100380964 100380995 100381265 100381726 100381768 100381822 100381823 100381826 100381829 100381830 100381832 100381840 100381841 100381843 100381844 100381845 100381848 100381856 100381901 100381906 100381908 100381911 100381912 100381923 100381924 100381928 100381930 100382181 100382190 100384081 100385057 100385165 100385304 100385305 100388680 201040139 201040199 201040202 201040206 201040208 201040210 201040213 201040214 201040311 201040314 201040327 100342965 100343117 100345137 100345591 100345624 100346213 100346218 100346249 100346261 201038743 100381339 100381905 100383913 100384289 100384873 100385163 100390089 100297860 100357138 100298655 100298659 100321724 100321729 100321905 100322861 100322870 100322890 100322896 100322897 100322901 100322902 100353273 100355396 100355670 100355878 100355890 100355895 100355926 100357131 100357731 100357749 100357770 100358145 100358148 100358312 100358341 100348173 100348175 100348176 100348178 100348440 100351489 100351490 100351495 100351497 100351546 100351553 100359604 100359767 100359949 100289710 100290611 100290612 100290642 100290646 100309491 100309492 100309578 100309641 100309646 100309733 100309736 100309738 100309820 100309823 100318609 100318616 100320638 100321702 100321714 100321720 100321796 100322865 100322879 100322884 100322886 100322887 100325103 100325104 100325108 100325117 100325118 100325260 100341866 100341896 100341904 100341908 100341997 100342528 100342896 100342956 100343113 100343120 100343151 100343158 100343162 100343524 100343544 100343568 100343622 100343700 100344208 100344215 100344219 100344370 100344662 100344668 100344670 100344677 100344679 100344680 100344685 100344686 100344689 100344690 100344969 100344970 100344972 100344973 100344975 100345116 100345122 100345140 100345142 100345143 100345144 100345146 100345147 100345151 100345153 100345154 100345303 100345308 100345312 100345339 100345342 100345345 100345518 100345564 100345566 100345570 100345571 100345573 100345581 100345583 100345608 100346257 100346275 100346277 100346297 100346300 100346302 100346304 100346309 100346318 100346321 100346328 100346330 100346331 100346853 100346875 100348128 100348131 100348145 100348147 100348443 100350134 100350663 100350677 100350712 100350715 100350723 100350725 100350935 100351349 100351350 100351356 100351487 100351492 100351496 100351563 100351564 100351570 100351573 100351577 100351581 100351585 100351707 100351709 100351711 100351713 100351715 100351716 100351718 100351719 100351723 100351730 100351732 100351733 100351858 100352040 100352041 100352043 100352046 100352047 100352048 100352049 100352050 100352051 100352052 100352057 100352061 100352066 100352072 100352074 100352075 100352076 100352077 100352078 100352087 100352091 100352092 100352094 100352102 100352105 100352109 100352111 100352116 100352120 100352121 100352747 100352756 100352758 100352803 100352815 100352816 100353242 100353245 100353274 1… (truncated, 38498 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 100039944 100040070 100045713 100045728 100046139 100064525 100064561 100064565 100064566 100064717 100071592 100071593 100081759 100082460 100083215 100086784 100086887 100087022 100091384 100091385 100101055 100106443 100106507 100106523 100114030 100125962 100136656 100137203 100180416 100181591 100181614 100189483 100189758 100229116 100230021 100252575 100252788 201004061 201004067 201004363 201004374 201004375 201004687 100087603 100129448 100129779 100129782 100129783 100129784 100129785 100173086 100173089 100173090 100173095 100173097 100173219 100173241 100173246 100173252 100173597 100243515 100243631 100243632 100243640 100243912 201007865 201008232 201011112 100118546 100118694 100260182 100260183 201013158 100189466 201029733 100036150 100036155 100067450 100107006 100160829 100190082 100219300 201026534 100026664 100026678 100029057 100029058 100029066 100029068 100029075 100029077 100029078 100029222 100029240 100037555 100045715 100045723 100059156 100084841 100084845 100084847 100084849 100084850 100085135 100085240 100086454 100114020 100137503 100146859 100181615 100181741 100190804 100229633 201002728 201004021 201004051 201004055 201004056 201004057 201004058 201004060 201004063 201004064 201008173 201029651 201029729 201029762 201029807 100116680 100116681 100116697 100116830 100116831 100116832 100118079 100118080 100118264 100124863 100124968 100147573 201008060 100026672 100026686 100026755 100026760 100029335 100031914 100031916 100037540 100037545 100037546 100037550 100037558 100038202 100038212 100038214 100045670 100045676 100045678 100045681 100045682 100045711 100045714 100045717 100045719 100045721 100045722 100045724 100045727 100045731 100046143 100073255 100085247 100091381 100091383 100104055 100104065 100106520 100114024 100118693 100137022 100137481 100147282 100147563 100174990 100181612 100230020 100237374 100237623 100237625 100237626 100237628 100237629 100237630 100237632 100237635 100237638 100261124 201001547 201001568 201001570 201001576 201002273 201002274 201002276 201002394 201002401 201002576 201002579 201002729 201002740 201002741 201002744 201002746 201002747 201002748 201002749 201002750 201002751 201002754 100038208 100045726 100118695 100125750 201001573 201004062 201004371 100037539 100046136 100046138 100046140 100046142 100046152 100086773 100086886 100091389 100098477 100100310 100103663 100106511 100106517 100118557 100118697 100163749 100164087 100176028 100181587 100181611 100181619 100189468 100189471 100189472 100189480 100189486 100229635 100229636 100229639 100230023 100244201 100251169 100254446 100254791 201002725 201029886 201029948 100029459 100036094 100036143 100036153 100036154 100036156 100036161 100036290 100039849 100040072 100040073 100045725 100045732 100046145 100046149 100046900 100050086 100050097 100064567 100064571 100064572 100064574 100064575 100064576 100064669 100064670 100064962 100071513 100071514 100073256 100075378 100075407 100081757 100082431 100082435 100082436 100082462 100087174 100091098 100091099 100091380 100091386 100091387 100091388 100091392 100091396 100100859 100101061 100101068 100101081 100103676 100104050 100104053 100104057 100104068 100104071 100104072 100106524 100106734 100114023 100114026 100114029 100118349 100118687 100118690 100118691 100118692 100125175 100125178 100125721 100125753 100125757 100125758 100125760 100125762 100125852 100125953 100125954 100125956 100125957 100125958 100136805 100136886 100137131 100146858 100147384 100147393 100147566 100147577 100163934 100174175 100174964 100174970 100174974 100174986 100176029 100176846 100180942 100181592 100181600 100189463 100189467 100189476 100189491 100189748 100190008 100190080 100190190 100190739 100190801 100190802 100195440 100195643 100195647 100195651 100195657 100195676 100195867 100195876 100195897 100196405 100196432 100219288 100219294 100219296 100219297 100219298 100219299 100219301 100219305 100219306 100228999 100229101 100230024 100230074 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 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 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 08-1251-1 - 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 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 08-2301-3 - 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 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 08-2251-0 - 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)
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 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 08-3201-4 - 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

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)
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

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 08-4231-0 - 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)