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Recalls affecting West Virginia

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

16,444 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
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

ALL 50 STATES
Full report

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

Recall #:
D-0311-2019
Lot/product code:
Lot # 3066051, exp. date 3/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

ALL 50 STATES
Full report

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

Recall #:
D-0312-2019
Lot/product code:
Lot # 3079500, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0308-2019
Lot/product code:
NDC 0093-7810-56 & NDC 0093-7810-98 Lot # 20X006
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0310-2019
Lot/product code:
All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0307-2019
Lot/product code:
NDC 0093-7807-56 & 0093-7807-98 Lot # 18X010, 18X011
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0309-2019
Lot/product code:
NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0303-2019
Lot/product code:
NDC 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0304-2019
Lot/product code:
NDC 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012, 24X013
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0306-2019
Lot/product code:
NDC 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X046, 26X047, 26X048, 26X049, 26X050, 26X051
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 27, 2018

SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

ALL 50 STATES
Full report

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

Recall #:
81702
Lot/product code:
BTC93: GTIN/UDI Lot/Serial Numbers 10673978522545 215691544 10673978522545 215691545 10673978522545 215737228 10673978522545 215737229 10673978522545 215782206 10673978522545 215782207 10673978522545 215816859 10673978522545 215816860 10673978522545 215857423 10673978522545 215857424 10673978522545 215903431 10673978522545 215946277 10673978522545 216245142 10673978522545 215875581 10673978522545 215875582 10673978522545 215875583 10673978522545 216045172 10673978522545 216062720 10673978522545 216107788 10673978522545 216150361 10673978522545 216199988 10673978522545 216238209 10673978522545 216245141 10673978522545 216372965 10673978522545 216372966 10673978522545 216372967 10673978522545 216421235 10673978522545 216421236 10673978522545 216438179  BTC98: GTIN/UDI Lot/Serial Numbers 10673978522576 215782205 10673978522576 215903430 10673978522576 216034160 10673978522576 216062718 10673978522576 216238210
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 27, 2018

RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

ALL 50 STATES
Full report

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

Recall #:
81702
Lot/product code:
BT920: GTIN/UDI Lot/Serial Numbers 10673978522460 216044420 10673978522460 216062719 10673978522460 216438180  BT926: GTIN/UDI Lot/Serial Numbers 10673978522477 215782209 10673978522477 215903433 10673978522477 216034158 10673978522477 216107790 10673978522477 216372963 10673978522477 216438301
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

ALL 50 STATES
Full report

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

Recall #:
D-0305-2019
Lot/product code:
NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 28, 2018

IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

ALL 50 STATES
Full report

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

Recall #:
81747
Lot/product code:
IntellaNav Open-Irrigated Ablation Catheter Material Number: M004R96200 Batch: 22208397 Expiration Date: 6/4/2021 Batch: 22389516 Expiration Date: 7/16/2021 Batch: 22525798 Expiration Date: 2/14/2020
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 28, 2018

IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

ALL 50 STATES
Full report

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

Recall #:
81747
Lot/product code:
IntellaTip MiFi Open-Irrigated Ablation Catheter Material Number: M004PM96200 Batch: 20368736 Expiration Date: 3/5/2020 Batch: 20531648 Expiration Date: 4/16/2020 Batch: 20560477 Expiration Date: 4/23/2020 Batch: 20566637 Expiration Date: 4/24/2020 Batch: 20628704 Expiration Date: 5/9/2020 Batch: 20628705 Expiration Date: 5/10/2020 Batch: 20763900 Expiration Date: 6/12/2020 Batch: 20769113 Expiration Date: 6/13/2020 Batch: 21318000 Expiration Date: 10/29/2020 Batch: 21318001 Expiration Date: 10/29/2020 Batch: 21357647 Expiration Date: 11/10/2020 Batch: 21463186 Expiration Date: 12/3/2020 Batch: 21543193 Expiration Date: 12/20/2020 Batch: 21574774 Expiration Date: 1/4/2021 Batch: 22195929 Expiration Date: 5/31/2021 Batch: 22202991 Expiration Date: 6/3/2021 Batch: 22290601 Expiration Date: 6/3/2021 Batch: 22305067 Expiration Date: 6/25/2021 Batch: 22315782 Expiration Date: 6/27/2021 Batch: 22317356 Expiration Date: 6/28/2021 Batch: 22327178 Expiration Date: 7/1/2021 Batch: 22329367 Expiration Date: 7/2/2021 Batch: 22330626 Expiration Date: 7/2/2021 Batch: 22371866 Expiration Date: 7/12/2021 Batch: 22371868 Expiration Date: 7/12/2021 Batch: 22379905 Expiration Date: 7/15/2021 Batch: 22435929 Expiration Date: 7/26/2021 Batch: 22435930 Expiration Date: 7/26/2021 Batch: 22438118 Expiration Date: 7/27/2021 Batch: 22455198 Expiration Date: 7/31/2021 Batch: 22499957 Expiration Date: 8/10/2021 Material Number: M004PM9620K20 Batch: 20371559 Expiration Date: 3/6/2020 Batch: 20542305 Expiration Date: 4/18/2020 Batch: 20548241 Expiration Date: 4/19/2020 Batch: 20639975 Expiration Date: 5/14/2020 Batch: 20677314 Expiration Date: 5/21/2020 Batch: 20772834 Expiration Date: 6/14/2020 Batch: 22321772 Expiration Date: 6/29/2021 Batch: 22326857 Expiration Date: 7/1/2021 Material Number: M004PM9620N40 Batch: 20371742 Expiration Date: 3/8/2020 Batch: 20463744 Expiration Date: 3/28/2020 Batch: 20622763 Expiration Date: 5/8/2020 Batch: 20775597 Expiration Date: 6/14/2020 Batch: 22340824 Expiration Date: 7/4/2021 Batch: 22371871 Expiration Date: 7/12/2021 Batch: 22374909 Expiration Date: 7/13/2021
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 28, 2018

Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

ALL 50 STATES
Full report

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

Recall #:
81747
Lot/product code:
Blazer Open Irrigated Ablation Catheter Material Number: M00496200, Batch: 20399570, Expiration Date: 3/13/2020 Batch: 21778776, Expiration Date: 2/21/2021 Batch: 22152470, Expiration Date: 5/21/2021 Batch: 22499259, Expiration Date: 8/13/2001 Material Number: M0049620N40 Batch::20413170, Expiration Date: 3/16/2020 Batch: 20809676, Expiration Date: 6/22/2020  Material Number: M0049620K20  Batch: 20403945, Expiration Date: 3/13/2020
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2018

System, Tomography Computed Emmission

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

Full report

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

Recall #:
85746
Lot/product code:
Model for Ventry: ASM001605, H3000YT, H3000YW, H3000YY, H3000ZW  Serial Numbers: 11075,11430,11137,11154,11138,11512,11322,11093,11301,11286,11294,11021,11078,11125,11235,11387, 11337, 11288,11396,11147,11039,11427,11328,11471,11251,11424,11448,11421,11450,11203,11468,11363,19016,11069,11127,11284,11124,11229,11057,11143,11515,11190,11001,11027,11297,11306,11061,11151,11161,11441,11248,11067,11247, 11435, 11077, 11513, 11497,  11206,11211,11347,19069,11085,11392,11169,11222,11325,19098,19082,11398,11420,11378,11166,11008,11470,19070,19086,19027 19044,19083,19065,19062,11464,11280,11469,11376,11310,11119,11501,19048,11076,11086,11031,11366,11214,11383,19009,11345, 11358,11183,11422,11004,11307,11074,11503,11276,11054,11270,11189,11142,11244,11060,11145,11260,11092,11431,11038,11170,19109,19015,19040,11087,11462,11465,11117,19085,11179,11414,11150,19012,19108,11365,11255,11176,11089,11374,11017,11279,11359, 11324,11146,11312,11320,19030,11272,11360,11371,11385,11467,11231,11511,11505,11059,11045,11230,11353,11409,11349,11148,11315,11410,11044,11461,19057,11228,11443,11123,11237,11082,11090,11303,11438,11287,11454,11491,11065,11084,11080,11212,11269, 11489,11517,11043,11299,11300,11213,11278,11417,11053,11070,11122,11025,11098,11372,11391,11393,11397,11389,11232,11234, 11063,11180,19002,11018,11051,11096,11485,16001,16007,19008,19097,11095,11210,11490,11030,11033,11309,11022,11403,11330, 11340,11162,11442,11014,11407,11514,11277,11402,11066,11167,11164,11226,11426,11308,11445,11208,11282,11404,11304,11185, 11181,11227,11264,11267,11289,11415,11311,11333,11331,11026,11412,11023,11290,11346,11405,11482,11221,11224,11369,11002, 11003,11118,11444,11449,11344,11029,11439,11182,11436,11356,11423,11478,11494,11215,11246,19072,11058,19080,11105,11475, 11472,11486,11032,11201,11113,11474,11296,16020,11091,11357,11121,11159,11252,11463,11498,11406,11487,11271,11437,11321, 11009,11216,11377,11132,11458,11133,11367,11516,19026,11317,11064,11195,11072,11305,11452,11219,11316,11373,11492,19005, 11062,11382,11245,11314,11103,11394,11400,11429,11432,11433,11323,11342,11007,11205,11202,11281,11129,11225,11010,19025, 11097,11171,11350,11368,11049,11268,11131,11481,11186,11476,00000000VEN002, 0000E3GT09163A, 0000E3GT08038A, 00000000VEN003.
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2018

System, Tomography Computed Emmission

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

Full report

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

Recall #:
85746
Lot/product code:
Model for Discovery NM 530c: 5248934, 5166674-01, H3000SA, H3001JA, H3001JD.  Serial Numbers:  19016,0000000ME11041,19069,19098,19082,19070,19086,19027,19044,19083,19065,19062,19048,19009,19109,19015,19040,19085,19012, 19108, 19030, 19057,000000109961-1,19002,16001,16007,19008,19097,19072,19080,16020,19026,19005,19025,0000000000ME-4.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2018

Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Full report

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

Recall #:
81783
Lot/product code:
500FR
Recalling firm:
Randox Laboratories Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2018

Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Full report

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

Recall #:
81783
Lot/product code:
498FR
Recalling firm:
Randox Laboratories Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2018

Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Full report

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

Recall #:
81783
Lot/product code:
499FR
Recalling firm:
Randox Laboratories Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 5, 2018

UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Full report

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

Recall #:
82079
Lot/product code:
Systems running software versions: 5.2, 5.3.0, 5.3.1.
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 5, 2018

The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Full report

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

Recall #:
82079
Lot/product code:
Systems running software versions: 5.2, 5.3.0, 5.3.1. Serial #: 605042 605047 605048 605050 606363 606439 901612 901626 605300 605301 605516 900777 605636 606566 606567 606383 606744 606745 605996 606161 606169 606231 606500 606565 606155 606156 606302 606740 606743 604566 604622 604624 604627 604713 606646 606746 604912 604951 606128 606386 606324 605932 606755 603377 604309 605909 604410 605372 604178 604426 604796 604744 602700 603298 603660 603797 603897 605762 604608 606411 604345 602472 603059 603513 603837 601829 602930 603217 604703 605201 605216 606557 604207 604929 605768 605769 605978 602139 606572 602417 601931 606104 602469 604115 604947 604682 604733 601919 602088 606201 601852 604699 605302 603647 606090 602077 602601 605449 603250 605199 605736 604827 603609 605492 604628 602084 602310 605211 605633 606763 606770 602074 604307 606257 604046 602063 603338 603481 604940 605179 602091 604080 606467 604698 602422 605812 604150 603255 605653 605923 603268 605894 601988 605172 602487 605212 605735 603231 603531 604457 602259 606089 602772 606455 604602 604730 604743 605133 603953 602489 605346 605076 604927 605712 604741 604739 605683 604767 604130 602618 602657 606210 604471 606353 603358 603368 604482 603811 603603 603226 602866 603390 602878 602833 605931 601881 606592 603955 602462 602522 606237 600742 602147 602058 603991 604768 605141 605893 605454 603893 603253 603346 603996 602359 602671 602856 603382 603427 603442 604653 602435 604725 604141 604842 601697 602915 603375 604953 605376 603239 603980 605504 605569 606129 602810 602477 605389 603022 604580 604025 601707 601926 602357 602389 602400 603139 603288 603533 602863 605355 605359 605539 602433 606018 606177 606238 606402 606585 606589 606602 606651 606712 606714 606715 606716 606717 606718 606725 606898 606903 605597 604934 604065 603964 603223 603233 605376 603199 604220 606704 603121 603661 604000 603780 603783 601096 604311 606190 603784 604604 606463 606722 604829 605037 605688 602140 603025 603950 605339 605861 604350 603890 603895 605914 603076 605295 603068 605718 603528 602545 602327 606087 602168 605498 603532 602718 602859 605178 605877 602198 605207 605639 606327 603370 606559 603519 602397 605757 603485 605877 605879 604771 603081 604447 606325 604613 604931 603912 604225 602173 602969 605137 605029 605282 603786 605668 606704 606818 606876 606129 606504 606555 606726 606727 604248 604756 606240 605344 604817 606158 603460 602305 605197 606091 605576 604414 604043 606672 606035 606279 602846 606040 603342 603234 605979 602552 603561 603563 603070 606374 603518 602105 603530 602933 603971 602183 604973 605936 603658 604742 602644 606401 604541 603079 602955 606123 606625 602985 602934 606199 603506 604679 604748 603334 603674 604455 606073 603806 602149 606260 603607 603608 604612 605396 606904 604500 604581 605433 606901 602285 605644 605658 604899 604487 602888 605009 605621 604643 605095 602758 604676 604595 603549 602321 604978 606407 606709 603565 606361 606773 606776 606552 606554 606555 606562 606568 606570 606571 606573 602145 606025 606203 606205 606649 603191 602426 602903 603072 603283 604887 602838 602983 603020 604567 605665 606157 605659 602029 602543 605453 605544 602046 605190 604894 602846 604368 604373 605369 601793 602668 604027 604955 605198 605458 602381 605542 602430 606458 602332 602843 606213 606214 603731 603452 605686 603795 605185 604737 602904 604029 604036 605451 601713 604736 603854 605895 602705 604387 604443 603141 603064 601596 601886 605661 604214 602643 605455 604880 602261 604690 604869 602986 606896 606902 602707 605631 606229 602699 602024 603986 606830 606833 606183 601837 603156 605905 606173 603286 602152 604865 606590 604870 604537 601759 603744 605377 602932 605489 605791 605918 603679 602261 602411 605176 605715 606079 606329 602749 605324 604556 603455 605332 606382 603269 603321 603502 602808 605558 601976 601781 601934 602543 605820 603804 604640 603098 604707 604929 604950 605737 603814 601825 605250 605379 661824 605729 604731 605758 603360 603169 605946 603296 603978 605263 602736 603918 602280 604089 604828 605365 605518 603339 606309 606560 606561 606751 606753 604550 604059 604629 602338 602811 602344 603809 602954 602652 606070 602733 606510 604146 605284 605007 603857 602821 605134 606650 603232 604588 604634 605481 603175 605442 603773 603656 601245 602756 603969 604958 603149 602030 604183 604174 602265 606608 606627 606695 606700 606701 606704 606375 606377 604547 602748 603165 601762 605953 602083 600873 601473 606077 603591 603344 603474 605568 605903 604319 601840 605407 602886 606640 605708 605338 606551 602647 603035 606162 602209 602910 602191 604205 601907 604208 605469 602709 604424 606742 606880 603436 605214 605915 603743 604787 604567 605774 602225 604784 606057 603369 602588 605342 602161 604289 603622 602853 602159 602482 604683 605406 605860 605354 602828 606644 606459 603194 605588 602761 605571 606114 606116 603192 604763 604975 604978 605897 602950 6… (truncated, 19957 characters total — see the official FDA record for the full value)
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 6, 2018

BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.

Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.

ALL 50 STATES
Full report

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

Recall #:
81750
Lot/product code:
Product Code A319418AM;  Lot NGCT1929;  Exp. Date 11/30/2018
Recalling firm:
Bard Medical Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 13, 2018

MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.

ALL 50 STATES
Full report

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

Recall #:
81785
Lot/product code:
MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher.   UDI 858164002084 858164002091 858164002107 858164002220 858164002237
Recalling firm:
Elekta, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 20, 2018

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

ALL 50 STATES
Full report

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

Recall #:
D-0505-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lot BP02C008, exp 03/2019; [1000-count bottle] Lots BEF7D006, exp 03/2020
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)