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Recalls affecting Idaho

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

16,424 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 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

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

McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 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;
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 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

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 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 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 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.

ALL 50 STATES
Full report

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
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
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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.
View official FDA record (opens in a new tab)
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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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
View official FDA record (opens in a new tab)
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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Full report

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.
View official FDA record (opens in a new tab)
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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Full report

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.
View official FDA record (opens in a new tab)
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.
View official FDA record (opens in a new tab)
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 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
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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Full report

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 30, 2019

ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

ALL 50 STATES
Full report

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

Recall #:
83813
Lot/product code:
1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M13F1152G, M13F1153G, M13F1154G, M13F1155G, M13F1164G, M13F1165G, M13F1166G, M13F1168G, M13F1169G, L13F0687G, D23F1925G, D23F1968G, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, J13F0291G, J13F0292G, J13F0300G, M13F0950G, M13F1150G, B23F1313G, M13F0995G, M13F1044G, C23F1699G, J13F0293G, J13F0294G, J13F0295G, J13F0374G, J13F0375G, J13F0378G, J13F0379G, L13F0721G, L13F0729G, L13F0767G, L13F0768G, L13F0769G, M13F1062G, M13F1063G, E23F2068G, M13F1069G, D23F1852G, K13F0415G, K13F0426G, B23F1454G, D23F1971G, D23F1987G, K13F0411G, K13F0387G, L13F0755G, M13F1141G, M13F1142G, J13F0333G, J13F0203G, D23F1936G, M13F0991G, B23F1452G, B23F1509G, D23F1980G, D23F1982G, E23F2064G, J13F0308G, M13F1032G, M13F1034G, M13F1046G, M13F1047G, L13F0669G, A23F1266G, A23F1267G, A23F1297G, C23F1589G, B23F1357G, B23F1358G, M13F1074G, D23F1859G, D23F1933G, F23F2081G, F23F2090G, F23F2091G, F23F2092G, F23F2111G, A23F1263G, B23F1362G, C23F1690G, D23F1877G, D23F1888G, D23F1997G, D23F2014G, J13F0250G, J13F0252G, J13F0255G, K13F0462G, K13F0464G, K13F0518G, K13F0533G, L13F0691G, L13F0692G, L13F0741G, M13F0917G, M13F0927G, M13F0939G, M13F0972G, M13F0973G, M13F0993G, M13F0994G, M13F1033G, M13F1045G, M13F1048G, M13F1051G, M13F1070G, M13F1106G, M13F1107G, M13F1108G, M13F1114G, M13F1146G, D23F1867G, L13F0631G, C23F1809G, D23F1835G, L13F0607G, C23F1777G, J13F0222G, J13F0219G, C23F1800G, C23F1801G, C23F1802G, J13F0072G, B23F1346G, B23F1347G, B23F1348G, D23F1853G, M13F1073G, D23F1854G, D23F1855G, D23F1856G, B23F1516G, B23F1526G, B23F1527G, C23F1649G, C23F1779G, K13F0566G, J13F0245G, M13F0940G, D23F1958G, E23F2079G, E23F2072G, K13F0431G, K13F0432G, K13F0435G, K13F0563G, K13F0564G, K13F0565G, A23F1250G, A23F1257G, B23F1316G, J13F0313G, J13F0314G, J13F0315G, A23F1246G, A23F1249G, C23F1728G, C23F1757G, D23F1994G, M13F1040G, L13F0616G, L13F0861G, J13F0273G, A23F1282G, K13F0475G, C23F1767G, C23F1769G, C23F1770G, C23F1772G, D23F1846G, J13F0367G, J13F0368G, D23F1946G, B23F1510G, B23F1512G, B23F1513G, B23F1517G, B23F1521G, B23F1529G, B23F1530G, B23F1534G, B23F1539G, B23F1544G, C23F1725G, C23F1726G, K13F0524G, L13F0724G, L13F0730G, A23F1196G, A23F1198G, B23F1473G, L13F0809G, L13F0810G, L13F0811G, L13F0813G, L13F0814G, C23F1817G, C23F1818G, D23F1839G, M13F0949G, J13F0048G, J13F0189G, J13F0280G, J13F0281G, J13F0348G, M13F1049G, M13F1050G, C23F1723G, D23F1967G, K13F0402G, K13F0406G, K13F0407G, M13F0969G, M13F0975G, M13F0941G, M13F0948G, J13F0324G, B23F1518G, B23F1538G, M13F1052G, M13F1053G, M13F1066G, M13F1067G, K13F0506G, E23F2030G, B23F1423G, B23F1498G, C23F1750G, C23F1756G, D23F1864G, D23F1879G, D23F1960G, D23F2614G, M13F1130G, M13F1131G, D23F2001G, E23F2069G, M13F0976G, M13F1054G, M13F1136G, M13F1137G, M13F1148G, M13F1149G, A23F1286G, M13F1030G, M13F1031G, B23F1309G, J13F0323G, J13F0271G, L13F0614G, L13F0615G, L13F0663G, M13F0945G, M13F0946G, A23F1294G, B23F1528G, M13F1098G, C23F1786G, A23F1224G, A23F1240G, A23F1269G, B23F1329G, B23F1546G, B23F1547G, D23F1841G, D23F1845G, D23F1848G, D23F1947G, D23F1953G, D23F1954G, D23F1956G, D23F2013G, D23F2016G, D23F2017G, J13F0242G, J43F0481G, L13F0612G, M13F1122G, C23F1585G, L13F0637G, A23F1291G, A23F1293G, C23F1791G, L13F0713G, L13F0714G, L13F0685G, B23F1363G, C23F1789G, C23F1790G, C23F1813G, D23F1926G, D23F1966G, D23F1969G, D23F2000G, D23F2018G, D23F2019G, J13F0026G, J13F0247G, J13F0316G, J13F0317G, J13F0382G, J13F0383G, J13F0384G, K13F0390G, K13F0463G, L13F0753G, L13F0840G, L13F0841G, L13F0842G, M13F1056G, M13F1160G, B23F1372G, D23F1908G, D23F2012G, E23F2031G, L13F0594G, L13F0606G, M13F1110G, M13F1111G, M13F1112G, M13F1113G, M13F1115G, M13F1116G, M13F1117G, M13F1118G, M13F1119G, K13F0465G, K13F0482G, K13F0483G, L13F0596G, L13F0602G, D23F1998G, L13F0772G, M13F1089G, M13F1143G, M13F0928G, F23F2080G, C23F1785G, C23F1795G, D23F1913G, A23F1247G, A23F1248G, A23F1251G, A23F1252G, A23F1253G, B23F1305G, B23F1306G, B23F1314G, B23F1317G, B23F1318G, B23F1320G, B23F1376G, B23F1407G, B23F1408G, B23F1409G, B23F1410G, B23F1457G, B23F1458G, B23F1459G, B23F1460G, B23F1461G, B23F1462G, B23F1463G, B23F1464G, B23F1472G, B23F1474G, B23F1481G, B23F1482G, B23F1491G, B23F1492G, B23F1493G, B23F1494G, C23F1695G, C23F1696G, C23F1697G, C23F1698G… (truncated, 535363 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2019

SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

Problem with packaging sealing process which affects sterility.

ALL 50 STATES
Full report

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

Recall #:
83714
Lot/product code:
Lot Numbers 1240 through 1313. Item numbers:   1. 321151-30C;   2. 331151-30C;   3. 321151-31C;   4. 341151-30C;   5. 321151-31A;   6. 341151-31A;   7. 341151-31B;   8. 331151-31B
Recalling firm:
Pajunk GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2019

Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

ALL 50 STATES
Full report

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

Recall #:
83797
Lot/product code:
Product Number / CFN GTIN Lot EUP1506X 00643169559813 217238068 EUP1506X 00643169618695 217291131 EUP1506X 00643169559813 217354645 EUP1506X 00643169979475 217473721 EUP1506X 00643169618695 217473914 EUP1506X 00643169979475 217506615 EUP1506X 00643169979475 217576082 EUP1506X 00643169559813 217638054 EUP1506X 00643169559813 217833021 EUP1506X 00643169979475 217876349 EUP1510X 00643169559820 217225186 EUP1510X 00643169559820 217238070 EUP1510X 00643169618633 217262907 EUP1510X 00643169559820 217371289 EUP1510X 00643169979413 217396792 EUP1510X 00643169979413 217451079 EUP1510X 00643169979413 217473910 EUP1510X 00643169618633 217473911 EUP1510X 00643169979413 217518609 EUP1510X 00643169559820 217602408 EUP1510X 00643169559820 217610624 EUP1510X 00643169618633 217630776 EUP1510X 00643169559820 217656465 EUP1510X 00643169618633 217704793 EUP1510X 00643169979413 217704794 EUP1510X 00643169979413 217803293 EUP1510X 00643169559820 217804976 EUP1510X 00643169979413 217817346 EUP1510X 00643169979413 217939845 EUP1510X 00643169979413 217960062 EUP1512X 00643169979338 217282165 EUP1512X 00643169559837 217282749 EUP1512X 00643169559837 217290758 EUP1512X 00643169618558 217291003 EUP1512X 00643169618558 217396342 EUP1512X 00643169979338 217451080 EUP1512X 00643169559837 217518423 EUP1512X 00643169979338 217584296 EUP1512X 00643169618558 217728406 EUP1512X 00643169559837 217791032 EUP1512X 00643169618558 217803295 EUP1512X 00643169979338 217817347 EUP1512X 00643169559837 217833023 EUP1512X 00643169979338 217876348 EUP1515X 00643169618688 217216700 EUP1515X 00643169979468 217216702 EUP1515X 00643169559844 217225187 EUP1515X 00643169979468 217270937 EUP1515X 00643169979468 217291129 EUP1515X 00643169618688 217291133 EUP1515X 00643169559844 217379139 EUP1515X 00643169979468 217387047 EUP1515X 00643169618688 217396791 EUP1515X 00643169979468 217451566 EUP1515X 00643169618688 217518610 EUP1515X 00643169979468 217518611 EUP1515X 00643169979468 217584297 EUP1515X 00643169979468 217601078 EUP1515X 00643169979468 217630784 EUP1515X 00643169559844 217638060 EUP1515X 00643169559844 217727985 EUP1515X 00643169618688 217728244 EUP1515X 00643169618688 217775695 EUP1515X 00643169979468 217777586 EUP1515X 00643169559844 217786006 EUP1515X 00643169618688 217791230 EUP1515X 00643169979468 217960063 EUP1515X 00643169559844 217961583 EUP1520X 00643169559851 217253539 EUP1520X 00643169618923 217270929 EUP1520X 00643169979703 217270933 EUP1520X 00643169559851 217313635 EUP1520X 00643169979703 217339009 EUP1520X 00643169979703 217370779 EUP1520X 00643169979703 217387049 EUP1520X 00643169979703 217427611 EUP1520X 00643169979703 217444053 EUP1520X 00643169979703 217480193 EUP1520X 00643169559851 217488906 EUP1520X 00643169618923 217506621 EUP1520X 00643169979703 217518608 EUP1520X 00643169618923 217518614 EUP1520X 00643169979703 217577127 EUP1520X 00643169618923 217682939 EUP1520X 00643169618923 217775696 EUP1520X 00643169559851 217791033 EUP1520X 00643169559851 217875827 EUP2006X 00643169559868 217290755 EUP2006X 00643169559868 217325279 EUP2006X 00643169979574 217473906 EUP2006X 00643169979574 217506617 EUP2006X 00643169979574 217601073 EUP2006X 00643169559868 217602407 EUP2006X 00643169979574 217616434 EUP2006X 00643169559868 217646822 EUP2006X 00643169979574 217682942 EUP2006X 00643169618794 217721594 EUP2006X 00643169559868 217791029 EUP2006X 00643169559868 217913568 EUP2010X 00643169559875 217313603 EUP2010X 00643169559875 217371290 EUP2010X 00643169559875 217465238 EUP2010X 00643169618862 217490849 EUP2010X 00643169618862 217506623 EUP2010X 00643169559875 217535671 EUP2010X 00643169979642 217542638 EUP2010X 00643169979642 217557954 EUP2010X 00643169979642 217584304 EUP2010X 00643169979642 217602587 EUP2010X 00643169979642 217616444 EUP2010X 00643169559875 217656461 EUP2010X 00643169979642 217682944 EUP2010X 00643169559875 217728347 EUP2010X 00643169979642 217728410 EUP2010X 00643169559875 217860167 EUP2010X 00643169979642 217891539 EUP2012X 00643169979307 217225194 EUP2012X 00643169979307 217246462 EUP2012X 00643169979307 217270930 EUP2012X 00643169979307 217282164 EUP2012X 00643169979307 217291005 EUP2012X 00643169559882 217325272 EUP2012X 00643169618527 217339010 EUP2012X 00643169979307 217339011 EUP2012X 00643169559882 217339173 EUP2012X 00643169559882 217347821 EUP2012X 00643169559882 217379135 EUP2012X 00643169618527 217379610 EUP2012X 00643169979307 217379612 EUP2012X 00643169979307 217387051 EUP2012X 00643169618527 217387053 EUP2012X 00643169559882 217418683 EUP2012X 00643169559882 217465237 EUP2012X 00643169979307 217451567 EUP2012X 00643169559882 217479184 EUP2012X 00643169559882 217518421 EUP2012X 00643169559882 217535675 EUP2012X 00643169979307 217557965 EUP2012X 00643169979307 217584406 EUP2012X 00643169979307 217602590 EUP2012X 00643169979307 217630783 EUP2012X 00643169559882 217646823 EUP2012X 00643169559882 217668159 EUP2012X 00643169979307 217704795 EUP2012X 00643169559882 217713354 EUP2012X 00643169618527 217713408 EUP201… (truncated, 27676 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular Galway DBA Medtronic Ireland
View official FDA record (opens in a new tab)