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Recalls affecting Kansas

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

16,731 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 Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa 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. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit 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

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

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)
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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
All Lots: Note:This product was not distributed within the US
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-410125, LF-410150,LF-410175,LF-410205,LF-410240,LF-410270,LF-410310,LF-410390,LF-410440,LF-410490,LF-410540,LF-410595,LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; style LX: LX-410145,LX-410175,LX-410195,LX-410225,LX-410255,LX-410290,LX-410330,LX-410365,LX-410405,LX-410455,LX-410515,LX-410570,LX-410625; Style ML: ML-410125,ML-410170,ML-410195,ML-410220,ML-410285; Style MM: MM-410160,MM-410185,MM-410215,MM-410245,MM-410280,MM-410320,MM-410360,MM-410400,MM-410450; Style MF: MF-410140MF-410165,MF-410195,MF-410225,MF-410255,MF-410295,MF-410335,MF-410375,MF-410420,MF-410470,MF-410525,MF-410580,MF-410640; Style MX: MX-410165,MX-410195,MX-410225,MX-410255,MX-410290,MX-410325,MX-410370,MX-410410,MX-410445,MX-410520,MX-410550,MX-410620,MX-410685; Style FL: FL-410140,FL-410190,FL-410220,FL-410250,FL-410320; Style FM:FM-410155,FM-410180,FM-410205,FM-410235,FM-410270,FM-410310,FM-410350,FM-410395,FM-410440,FM-410500,FM-410550,FM-410605,FM-410670; Style FF: FF-410160,FF-410185,FF-410220,FF-410255,FX-410290,FF-410335,FF-410375,FF-410425,FF-410475,FF-410535,FF-410595,FF-410655,FF-410740; Style FX: FX-410185FX-410215,FX-410245,FX-410280,FX-410315,FX-410360,FX-410410,FX-410450,FX-410495,FX-410560,FX-410615,FX-410690,FX-410775 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS   Product Code/UDI  Style LL: LL-410135/10888628003170,LL-410180/10888628003187,LL-410210/10888628003194,LL-410240/10888628003200,LL-410300/10888628003217; Style LM: LM-410140/10888628003224,LM-410190/10888628003231,LM-410220/10888628003248,LM-410250/10888628003255,LM-410320/10888628003262; Style LF: LF-410125/10888628003057,LF-410150/10888628003064,LF-410175/10888628003071,LF-410205/10888628003088,LF-410240/10888628003095,LF-410270/10888628003101,LF-410310/10888628003118,LF-410390/10888628003125,LF-410440/10888628003132,LF-410490/10888628003149,LF-410540/10888628003156,LF-410595/10888628003163; Style LX: LX-410145/10888628003279,LX-410175/10888628003286,LX-410195/10888628003293,LX-410225/10888628003309,LX-410255/10888628003316,LX-410290/10888628003323,LX-410330/10888628003330,LX-410365/10888628003347,LX-410405/10888628003354,LX-410455/10888628003361,LX-410515/10888628003378,LX-410570/10888628003385,LX-410625/10888628003392; Style ML: ML-410125/10888628003538,ML-410170/10888628003545,ML-410195/10888628003552,ML-410220/10888628003569,ML-410285/10888628003576; Style MM: MM-410160 10888628003583,MM-410185/10888628003590,MM-410215/10888628003606,MM-410245/10888628003613,MM-410280/10888628003620,MM-410320/10888628003637,MM-410360/10888628003644,MM-410400/10888628003651,MM-410450/10888628003668; Style MF:MF-410140/10888628003408,MF-410165/10888628003415,MF-410195/10888628003422,MF-410225/10888628003439,MF-410255/10888628003446,MF-410295/10888628003453,MF-410335/10888628003460,MF-410375/10888628003477,MF-410420/10888628003484,MF-410470/10888628003491,MF-410525/10888628003507,MF-410580/10888628003514,MF-410640/10888628003521; Style MX:MX-410165/10888628003675,MX-410195/10888628003682,MX-410225/10888628003699,MX-410255/10888628003705,MX-410290/10888628003712,MX-410325/10888628003729,MX-410370/10888628003736,MX-410410/10888628003743,MX-410445/10888628003750,MX-410520/10888628003767,MX-410550/10888628003774,MX-410620/10888628003781,MX-410685/10888628003798;  Style FL: FL-410140/10888628002746,FL-410190/10888628002753,FL-410220/10888628002760,FL-410250/10888628002777,FL-410320/10888628002784; Style FM:FM-410155/10888628002791,FM-410180/10888628002807,FM-410205/10888628002814,FM-410235/10888628002821,FM-410270/10888628002838,FM-410310/10888628002845,FM-410350/10888628002852,FM-410395/10888628002869,FM-410440/10888628002876,FM-410500/10888628002883,FM-410550/10888628002890,FM-410605/10888628002906,FM-410670/10888628002913; Style FF: FF-410160/10888628002616,FF-410185/10888628002623,FF-410220/10888628002630,FF-410255/10888628002647,FF-410290/10888628002654,FF-410335/10888628002661,FF-410375/10888628002678,FF-410425/10888628002685,FF-410475/10888628002692,FF-410535/10888628002708,FF-410595/10888628002715,FF-410655/10888628002722,FF-410740/10888628002739;  Style FX: FX-410185/10888628002920,FX-410215/10888628002937,FX-410245/10888628002944,FX-410280/10888628002951,FX-410315/10888628002968,FX-410360/10888628002975,FX-410410/10888628002982,FX-410450/10888628002999,FX-410495/10888628003002,FX-410560/10888628003019,FX-410615/10888628003026,FX-410690/10888628003033,FX-410775/10888628003040;
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
All Lots: Note:This product was not distributed within the US
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
All Lots: Note:This product was not distributed within the US
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
All Lots: Note:This product was not distributed within the US
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
All Lots: Note:This product was not distributed within the US
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
All Lots: Note:This product was not distributed within the US
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS;
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2019

Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

ALL 50 STATES
▸Full report

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

Recall #:
83532
Lot/product code:
Model Number: 2082844-001;   Serial Number (UDI Number): TABY70690 (010084068211686221TABY7069011190610), TABY70692 (010084068211686221TABY7069211190611), TABY70708 (010084068211686221TABY7070811190612), TABY70719 (010084068211686221TABY7071911190613), TABY70709 (010084068211686221TABY7070911190612), TABY70724 (010084068211686221TABY7072411190614), TABY70722 (010084068211686221TABY7072211190614), TABY70718 (010084068211686221TABY7064211190603), TABY70717 (010084068211686221TABY7064411190603), TABY70712 (010084068211686221TABY7064511190603), TABY70678 (010084068211686221TABY7067811190607), TABY70725 (010084068211686221TABY7072511190615), TABY70672 (010084068211686221TABY7067211190607), TABY70686 (010084068211686221TABY7068611190610), TABY70688 (010084068211686221TABY7068811190610), TABY70697 (010084068211686221TABY7069711190611), TABY70726 (010084068211686221TABY7072611190616), TABY70729 (010084068211686221TABY7072911190616), TABY70645 (010084068211686221TABY7064711190604), TABY70647 (010084068211686221TABY7066011190605), TABY70646 (010084068211686221TABY7071211190613), TABY70644 (010084068211686221TABY7071711190613), TABY70642 (010084068211686221TABY7071811190613), TABY70732 (010084068211686221TABY7073211190617), TABY70723 (010084068211686221TABY7072311190614), TABY70747 (010084068211686221TABY7074711190619), TABY70748 (010084068211686221TABY7074811190619), TABY70673 (010084068211686221TABY7067311190607), TABY70676 (010084068211686221TABY7067611190607), TABY70693 (010084068211686221TABY7069311190611), TABY70648 (010084068211686221TABY7064811190604), TABY70675 (010084068211686221TABY7067511190607), TABY70694 (010084068211686221TABY7069411190611), TABY70695 (010084068211686221TABY7069511190611), TABY70730 (010084068211686221TABY7073011190617), TABY70734 (010084068211686221TABY7073411190617), TABY70737 (010084068211686221TABY7073711190618), TABY70677 (010084068211686221TABY7067711190607), TABY70698 (010084068211686221TABY7069811190611), TABY70699 (010084068211686221TABY7069911190611), TABY70703 (010084068211686221TABY7070311190612), TABY70706 (010084068211686221TABY7070611190612), TABY70727 (010084068211686221TABY7072711190616), TABY70728 (010084068211686221TABY7072811190616), TABY70660 (010084068211686221TABY7064611190603), TABY70689 (010084068211686221TABY7068911190610), TABY70705 (010084068211686221TABY7070511190612), TABY70707 (010084068211686221TABY7070711190612), TABY70731 (010084068211686221TABY7073111190617), TABY70733 (010084068211686221TABY7073311190617), TABY70652 (Not Available),  TABY70654 (Not Available), TABY70662 (Not Available), TABY70664 (Not Available), TABY70710 (Not Available), TABY70715 (Not Available), TABY70716 (Not Available), TABY70753 (Not Available), TABY70659 (Not Available), TABY70704 (010084068211686221TABY7070411190612),  TABY70755 (010084068211686221TABY7075511190620), TABY70638 (Not Available), TABY70649 (Not Available), TABY70656 (Not Available), TABY70661 (Not Available), TABY70657 (Not Available), TABY70650 (Not Available), TABY70667 (Not Available), TABY70668 (Not Available), TABY70653 (Not Available), TABY70663 (Not Available), TABY70670 (Not Available), TABY70665 (Not Available), TABY70669 (Not Available), TABY70671 (Not Available), TABY70714 (Not Available), TABY70658 (Not Available), TABY70655 (Not Available), TABY70666 (Not Available), TABY70651 (Not Available).
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2019

Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.

The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

ALL 50 STATES
▸Full report

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

Recall #:
85301
Lot/product code:
AS9924-00-0002, RB011-00-0005,RB011-00-0006, RB011-00-0010, RB011-00-0012, RB011-00-0015, RB011-00-0017, RB011-00-0018, RB011-00-0019, RB011-00-0020, RB011-00-0021, RB011-0022, RB011-0023, RB011-0024, RB011-0025, RB011-0026, RB011-0027, RB011-0028, RB011-0029, RB011-0030, RB011-0031, RB011-0032, RB011-0033, RB011-0034, RB011-0035, RB011-0036, RB011-0037, RB011-0038, RB011-0039, RB011-0040, RB011-0041, RB011-0042, RB011-0044, RB011-0045, RB011-0046, RB011-0047, RB011-0048, RB011-0049, RB011-0050, RB011-0051, RB011-0052, RB011-0053, RB011-0054, RB011-0055, RB011-0056, RB011-0057, RB011-0058, RB011-0059, RB011-0060, RB011-0061, RB011-0062, RB011-0063, RB011-0064, RB011-0065, RB011-0066, RB011-0067, RB011-0068, RB011-0069, RB011-0070, RB011-0071, RB011-0072, RB011-0073, RB011-0074, RB011-0075, RB011-0076, RB011-0077, RB011-0078, RB011-0079, RB011-0080, RB011-0081, RB011-0082, RB011-0083, RB011-0084, RB011-0085, RB011-0086, RB011-0087, RB011-0088, RB011-0089, RB011-0090, RB011-0091, and RB011-0092.
Recalling firm:
MOTEK MEDICAL B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 30, 2019

RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Under certain conditions, a marble pattern infrequently appears on the monitor.

ALL 50 STATES
▸Full report

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

Recall #:
85299
Lot/product code:
RadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.
Recalling firm:
Eizo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 30, 2019

RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Under certain conditions, a marble pattern infrequently appears on the monitor.

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

Recall #:
85299
Lot/product code:
RadiForce GX560 - 1.0003 or earlier
Recalling firm:
Eizo Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled August 1, 2019

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

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

Recall #:
83491
Lot/product code:
Part Numbers:   1. 7590310-24;   2. 7590310-40;   3. 7590311-24;   4. 7590311-40;   5. 7590312-24;   6. 7590312-40;   7. 7590313-24;   8. 7590313-40;   9. 7590314-24;   10. 7590314-40;   11. 7590315-24;   12. 7590315-40;   13. 7590316-24;   14. 7590316-40;   15. 7590317-24;   16. 7590317-40;   17. 7590318-24-5;   18. 7590318-24-7;   19. 7590318-40-5;   20. 7590318-40-7;   21. 7590319-24-5;   22. 7590319-40-5;   23. 7590440;   24. 7590441;   25. 7590442;   26. 7590443;   27. 7590444;   28. 7590445;   29. 7590446;   30. 7590447;   31. 7590450-5;   32. 7590450-8
Recalling firm:
GN Otometrics
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Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Bizcocho de Guayaba y Coco (Guava-Coconut Pudding Cake); Peso Neto 14 ONZ. (397 G)

Failure to declare Sodium Metabisulfite.

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-2106-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
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Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Bizcocho de Queso y Guayaba (Cheese-Guava Pudding Cake); Peso Neto 14 ONZ. (397 G)

Failure to declare FD&C Yellow #5 and FD&C Yellow #6.

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-2105-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2019

Proteus XR/a (SlOK : K993090)

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

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

Recall #:
83647
Lot/product code:
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2019

Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

Samples in the identified lot were found to have incomplete or open packaging seals.

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

Recall #:
83551
Lot/product code:
Lot Number 19CAB954
Recalling firm:
Medline Industries Inc
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Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Brazo Gitano Guayaba Queso (Guava- Cheese Cake Roll); Peso Neto 12 ONZ. (340 G)

Failure to declare Soy, FD&C Yellow #5 and #6 and lack of Keep Refrigerated labeling.

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-2104-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2019

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

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

Recall #:
84859
Lot/product code:
Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
Recalling firm:
RESPIRATORY THERAPEUTICS GROUP LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2019

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

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

Recall #:
85324
Lot/product code:
Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
Recalling firm:
Intuitive Surgical, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

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

Recall #:
83558
Lot/product code:
Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/2019), 213898 (7/27/2019), 213901 (7/27/2019), 213902 (7/27/2019), 213904 (7/27/2019), 213910 (7/27/2019), 213919 (7/27/2019), 213921 (7/27/2019), 213937 (7/27/2019), 213938 (7/27/2019), 213943 (7/27/2019), 213946 (7/27/2019), 213961 (7/28/2019), 213972 (7/28/2019), 213975 (7/28/2019), 213976 (7/28/2019), 213979 (7/28/2019), 213982 (7/28/2019), 213983 (7/28/2019), 214020 (7/31/2019), 214030 (7/31/2019), 214032 (7/31/2019), 214036 (7/31/2019), 214042 (7/31/2019), 214083 (7/31/2019);
Recalling firm:
Boston Scientific Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.

Reports received of the device fracturing during insertion.

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

Recall #:
85218
Lot/product code:
Lot numbers 14LDDOCB, 15CNDOBC, 15DIDOCC, and 7FGAD.
Recalling firm:
CTL Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

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

Recall #:
83558
Lot/product code:
Model A219, Serial Number (Use Before Date) - 213636 (7/21/2019), 213637 (7/21/2019), 213638 (7/21/2019), 213639 (7/21/2019), 213640 (7/21/2019), 213641 (7/21/2019), 213642 (7/21/2019), 213643 (7/21/2019), 213644 (7/21/2019), 213645 (7/21/2019), 213646 (7/21/2019), 213647 (7/21/2019), 213648 (7/21/2019), 213649 (7/21/2019), 213650 (7/21/2019), 213651 (7/21/2019), 213652 (7/21/2019), 213653 (7/21/2019), 213654 (7/21/2019), 213655 (7/21/2019), 213656 (7/21/2019), 213657 (7/21/2019), 213658 (7/21/2019), 213659 (7/21/2019), 213660 (7/21/2019), 213661 (7/21/2019), 213662 (7/21/2019), 213663 (7/21/2019), 213665 (7/21/2019), 213666 (7/21/2019), 213667 (7/21/2019), 213668 (7/21/2019), 213669 (7/21/2019), 213670 (7/21/2019), 213671 (7/21/2019), 213672 (7/21/2019), 213673 (7/21/2019), 213674 (7/21/2019), 213675 (7/21/2019), 213676 (7/21/2019), 213677 (7/21/2019), 213678 (7/21/2019), 213679 (7/21/2019), 213680 (7/21/2019), 213681 (7/21/2019), 213682 (7/21/2019), 213683 (7/21/2019), 213684 (7/21/2019), 213685 (7/21/2019), 213686 (7/24/2019), 213687 (7/24/2019), 213688 (7/24/2019), 213689 (7/24/2019), 213690 (7/24/2019), 213691 (7/24/2019), 213692 (7/24/2019), 213693 (7/24/2019), 213694 (7/24/2019), 213695 (7/24/2019), 213696 (7/24/2019), 213697 (7/24/2019), 213698 (7/24/2019), 213699 (7/24/2019), 213700 (7/24/2019), 213701 (7/24/2019), 213702 (7/24/2019), 213703 (7/24/2019), 213704 (7/24/2019),  213705 (7/24/2019), 213706 (7/24/2019), 213707 (7/24/2019), 213708 (7/24/2019), 213709 (7/24/2019), 213710 (7/24/2019), 213712 (7/24/2019), 213713 (7/24/2019), 213714 (7/24/2019), 213715 (7/24/2019), 213716 (7/24/2019), 213717 (7/24/2019), 213718 (7/24/2019), 213719 (7/24/2019), 213720 (7/24/2019), 213721 (7/24/2019), 213722 (7/24/2019), 213723 (7/24/2019), 213724 (7/24/2019), 213726 (7/24/2019), 213727 (7/24/2019), 213728 (7/24/2019), 213730 (7/24/2019), 213731 (7/24/2019), 213732 (7/24/2019), 213733 (7/24/2019), 213734 (7/24/2019), 213735 (7/24/2019), 213736 (7/24/2019), 213737 (7/24/2019), 213738 (7/24/2019), 213739 (7/24/2019), 213740 (7/24/2019), 213741 (7/24/2019), 213742 (7/24/2019), 213743 (7/24/2019), 213744 (7/24/2019), 213745 (7/24/2019), 213746 (7/25/2019), 213747 (7/25/2019), 213748 (7/25/2019), 213749 (7/25/2019), 213750 (7/25/2019), 213751 (7/25/2019), 213752 (7/25/2019), 213753 (7/25/2019), 213754 (7/25/2019), 213755 (7/25/2019), 213756 (7/25/2019), 213757 (7/25/2019), 213758 (7/25/2019), 213759 (7/25/2019), 213760 (7/25/2019), 213761 (7/25/2019), 213762 (7/25/2019), 213763 (7/25/2019), 213764 (7/25/2019), 213765 (7/25/2019), 213766 (7/25/2019), 213767 (7/25/2019), 213768 (7/25/2019), 213769 (7/25/2019), 213770 (7/25/2019), 213771 (7/25/2019), 213772 (7/25/2019), 213773 (7/25/2019), 213774 (7/25/2019), 213775 (7/25/2019), 213776 (7/25/2019), 213777 (7/25/2019), 213778 (7/25/2019), 213779 (7/25/2019), 213780 (7/25/2019), 213782 (7/25/2019), 213783 (7/25/2019), 213784 (7/25/2019), 213785 (7/25/2019), 213786 (7/25/2019), 213787 (7/25/2019), 213788 (7/25/2019), 213789 (7/25/2019), 213790 (7/25/2019), 213791 (7/25/2019), 213792 (7/25/2019), 213793 (7/25/2019), 213794 (7/25/2019), 213795 (7/25/2019), 213796 (7/25/2019), 213797 (7/25/2019), 213798 (7/25/2019), 213799 (7/25/2019), 213800 (7/25/2019), 213801 (7/25/2019), 213802 (7/25/2019), 213803 (7/25/2019), 213804 (7/25/2019), 213805 (7/25/2019), 213806 (7/25/2019), 213807 (7/25/2019), 213808 (7/25/2019), 213809 (7/25/2019), 213810 (7/25/2019), 213811 (7/25/2019), 213812 (7/25/2019), 213813 (7/25/2019), 213814 (7/25/2019), 213815 (7/25/2019), 213816 (7/26/2019), 213817 (7/26/2019), 213818 (7/26/2019), 213819 (7/26/2019), 213820 (7/26/2019), 213821 (7/26/2019), 213822 (7/26/2019), 213823 (7/26/2019), 213824 (7/26/2019), 213826 (7/26/2019), 213827 (7/26/2019), 213828 (7/26/2019), 213830 (7/26/2019), 213831 (7/26/2019), 213832 (7/26/2019), 213833 (7/26/2019), 213834 (7/26/2019), 213835 (7/26/2019), 213836 (7/26/2019), 213837 (7/26/2019), 213838 (7/26/2019), 213839 (7/26/2019), 213840 (7/26/2019), 213841 (7/26/2019), 213843 (7/26/2019), 213844 (7/26/2019), 213845 (7/26/2019), 213846 (7/26/2019), 213847 (7/26/2019), 213848 (7/26/2019), 213849 (7/26/2019), 213850 (7/26/2019), 213851 (7/26/2019), 213852 (7/26/2019), 213853 (7/26/2019), 213854 (7/26/2019), 213855 (7/26/2019), 213856 (7/26/2019), 213857 (7/26/2019), 213858 (7/26/2019), 213860 (7/26/2019), 213861 (7/26/2019), 213862 (7/26/2019), 213863 (7/26/2019), 213864 (7/26/2019), 213865 (7/26/2019), 213866 (7/26/2019), 213867 (7/26/2019), 213868 (7/26/2019), 213869 (7/26/2019), 213870 (7/26/2019), 213871 (7/26/2019), 213872 (7/26/2019), 213874 (7/26/2019), 213875 (7/26/2019), 213876 (7/26/2019), 213877 (7/26/2019), 213878 (7/26/2019), 213879 (7/26/2019), 213880 (7/26/2019), 213881 (7/26/2019), 213882 (7/26/2019), 213883 (7/26/2019), 213884 (7/26/2019), 213885 (7/26/2019), 213886 (7/27/2019), 213887 (7/27/2019), 213888 (7/27/2019), 213889 (7/27/2019), 213890 (7/27/2019), 213892 (7/27/2019), 213893 (7/27/2019), 213894 (7/27/… (truncated, 8125 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.

Reports received of the device fracturing during insertion.

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

Recall #:
85218
Lot/product code:
Lot numbers 14LEDODB, 15CNDOGC, and 15DJDOEC .
Recalling firm:
CTL Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

Reports received of the device fracturing during insertion.

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

Recall #:
85218
Lot/product code:
Lot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD.
Recalling firm:
CTL Medical Corporation
View official FDA record (opens in a new tab)