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Recalls affecting Michigan

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

17,010 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 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 DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off

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

ALL 50 STATES
Full report

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

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

Philips Respironics V60 Ventilator Part Number 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 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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 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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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - 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 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 08-1301-4 - 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 08-4231-0 - 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 08-3301-2 - 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 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 08-2351-8 - 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 08-1251-1 - 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 08-2231-2 - 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 9, 2020

Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.

ALL 50 STATES
Full report

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

Recall #:
86734
Lot/product code:
SMS ID / Serial Number  SMS20200126 41F41E7A3011, SMS20200182 41F41E7A5006, SMS20200184 41F41E7A5008, SMS20180073 41F41DD7C006, SMS20180068 41F41DD7C003, SMS20180075 41F41DD7C007, SMS20180349 41F41DD85007, SMS20180350 41F41DD85009, SMS20180351 41F41DD86007, SMS20180448 41F41DD88001, SMS20190308 41F41E798002, SMS20190335 41F41E799002, SMS20190383 41F41E79A010, SMS20200033 41F41E79B001, SMS20200034 41F41E79B005, SMS20200219 41F41E7A6012, SMS20200301 41F41E7A6051, SMS20200339 41F41E7A7006, SMS20190016 41F41DD88010, SMS20190138 41F41DD8B007, SMS20190268 41F41E797001, SMS20190307 41F41E798003, SMS20200211 41F41E7A6005, SMS20200232 41F41E7A6020, SMS20200236 41F41E7A6024, SMS20200244 41F41E7A6025, SMS20200245 41F41E7A6026, SMS20180141 41F41DD83007, SMS20190008 41F41DD88007, SMS20190009 41F41DD88008, SMS20200325 41F41E7A6055, SMS20180076 41F41DD81002, SMS20190212 41F41DD8C012, SMS20200059 41F41E7A1007, SMS20200212 41F41E7A6010, SMS20200279 41F41E7A6041, SMS20200324 41F41E7A7002, SMS20200332 41F41E7A7005, SMS20200332 41F41E7A7005, SMS20190129 41F41DD8A018, SMS20190213 41F41DD8C013, SMS20200095 41F41E7A2004, SMS20200087 41F41E7A2006, SMS20200088 41F41E7A2007, SMS20200116 41F41E7A3002, SMS20200117 41F41E7A3003, SMS20180205 41F41DD83023, SMS20180230 41F41DD84006, SMS20190171 41F41DD8C002, SMS20190045 41F41DD89003, SMS20180374 41F41DD87004, SMS20200159 41F41DD87004, SMS20190189 41F41DD8C008, SMS20180117 41F41DD82008, SMS20180096 41F41DD82009, SMS20180097 41F41DD82010, SMS20180185 41F41DD83019, SMS20200129 41F41E7A4002, SMS20200130 41F41E7A4003, SMS20200131 41F41E7A4004, SMS20200132 41F41E7A4005, SMS20200206 41F41E7A6004, SMS20180242 41F41DD84019, SMS20190076 41F41DD89010, SMS20190113 41F41DD8A009, SMS20190092 41F41DD89013, SMS20200208 41F41E7A6002, SMS20180066 41F41DD7C004, SMS20180067 41F41DD7C005, SMS20190367 41F41E799010, SMS20190075 41F41DD89009, SMS20200096 41F41E7A2005, SMS20200280 41F41E7A6042, SMS20200348 41F41E7A7004, SMS20180115 41E09E963008, SMS20180082 41F41DD81005, SMS20180245 41F41DD85003, SMS20190160 41F41DD8B014, SMS20200165 41F41E7A4016, SMS20200271 41F41E7A6035, SMS20180065 41F41DD7C002, SMS20180104 41F41DD82011, SMS20200021 41F41E79B003, SMS20200040 41F41E7A1006, SMS20200042 41F41E7A1001, SMS20200148 41F41DD81010,, SMS20180129 41F41DD83001, SMS20180130 41F41DD83002, SMS20180131 41F41DD83003, SMS20180132 41F41DD83004, SMS20180133 41F41DD83005, SMS20180158 41F41DD83008, SMS20180159 41F41DD83009, SMS20180177 41F41DD83015, SMS20180178 41F41DD83016, SMS20190344 41F41DD7C003, SMS20180261 41F41DD85005, SMS20180262 41F41DD85006, SMS20200043 41F41E7A1002, SMS20200044 41F41E7A1003, SMS20200067 41F41E7A1004, SMS20200055 41F41E7A1009, SMS20200062 41F41E7A1010, SMS20180206 41F41DD83026, SMS20180237 41F41DD84013, SMS20180238 41F41DD84014, SMS20190003 41F41DD88004, SMS20200240 41F41E7A6029, SMS20200241 41F41E7A6030, SMS20200078 41F41E7A6032, SMS20180077 41F41DD81001, SMS20180078 41F41DD81003, SMS20200022 41F41E79B004, SMS20200227 41F41E7A6016
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)