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Recalls affecting Hawaii

Data last updated: September 11, 2026 at 1:08 PM UTC

16,303 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled November 5, 2025

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

Defective container - seal not adhering to bottles

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-0227-2026
Lot/product code:
Lot # QB00865, exp. date Feb 2028
Recalling firm:
Lupin Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV07222,PHV09082
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None; Lot Code: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

Product testing did not meet expected stability criteria.

ALL 50 STATES
Full report

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

Recall #:
97911
Lot/product code:
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Recalling firm:
Cepheid
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV08042
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled November 5, 2025

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

ALL 50 STATES
Full report

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

Recall #:
97942
Lot/product code:
UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Recalling firm:
Accriva Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2025

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

ALL 50 STATES
Full report

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

Recall #:
97946
Lot/product code:
Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2025

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

ALL 50 STATES
Full report

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

Recall #:
97946
Lot/product code:
Model No. (UDI): D998-00-0800-31 (10607567109053), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414); ALL SERIAL NO.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Continuous Glucose Monitor (CGM)

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221708952; SKU: CGM-15D; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Sorbitol Intolerance Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612787330; SKU: 2-B130; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

3 in 1 STI Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221704770; SKU: JD-3STI; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Mycoplasma test, IgG and IgM

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221710030; SKU: A-MYC; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

PSA Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612787316; SKU: G670D; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Liver Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221701724; SKU: D-LIV; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Women s Hormone Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612786999; SKU: O935; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Men s Hormone Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612787002; SKU: O934; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Leaky Gut Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785923; SKU: A500; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

IBS Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785930; SKU: IBS; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Fructose Intolerance Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612787323; SKU: 2B120; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Adrenal Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221708488; SKU: 2O320-1CO; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Vitamin D2 and D3 Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221709232; SKU: UD; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Organic Acids Profile Test Large

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221709263; SKU: UOAL; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Mycotoxin Panel Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221709300; SKU: UMT; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

GI Microbiome Profile XL

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221709225; SKU: UGXL; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)