State

Hawaii product recalls

73,100 recalls have nationwide distribution and so reach Hawaii. 2,770 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total: 2,770
Critical: 333
Severe: 569
Most recent: 2026-09-23

Of the 2,770 recalls naming Hawaii we have scored against our rubric, 333 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 569 (21%) are Severe.

Which agencies issued them

These figures cover only the 2,770 recalls whose distribution notice names Hawaii specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9426–9450 of 75870

HighFDA (Devices)·Z-0087-2025·2024-10-23
Leica Cryostat Model CM1850 Lacks Fire-Risk Warning for Flammable Sprays
Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.
Product
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0049-2025·2024-10-23
KINOVA Jaco assistive robot recalled for potential fire hazard
Kinova Inc is recalling 949 KINOVA Jaco assistive robots due to a potential fire hazard that may occur if a damaged robot arm interacts with a wheelchair exhibiting electrical leakage.
Product
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0061-2025·2024-10-23
Monarch Inflation Device Syringe Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
Product
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0034-2025·2024-10-23
Bevi Flavor#115 Electrolytes Recalled: Mislabeled, Contains Caffeine
Hydration Labs Inc. is recalling Flavor#115 Electrolytes (3.78L BIB units) distributed nationwide and in Canada because the product is labeled as electrolytes but actually contains caffeine.
Product
Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single unit for use in Bevi Smart Water Cooler machines dispensing flavored waters.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0068-2025·2024-10-23
BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk
BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.
Product
BlueFIRE Inflation Device, REF: IN10140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0108-2025·2024-10-23
Boston Scientific AVVIGO+ Imaging System Grid Display Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error causing incorrect grid overlay display when used with OptiCross 18 catheters, which could affect measurement accuracy.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0090-2025·2024-10-23
Leica Biosystems Cryostat Model CM3050 S lacks warning label for flammable sprays
Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.
Product
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0089-2025·2024-10-23
Cryostat Model CM1950 Lacks Warning on Flammable Spray Use
Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.
Product
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V790000·2024-10-23
Volvo trucks with Bendix EC80 units may lose safety system functions
Volvo Trucks is recalling certain 2020-2025 trucks with Bendix EC80 Advanced Electronic Control Units because electrical noise may cause the ECU to misprocess commands or stop working.
Product
VOLVO — VOLVO VHD, VN, VNRE (ELECTRIC), VAH
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0009-2025·2024-10-23
Duloxetine 20mg Delayed-Release Capsules Recalled for N-Nitroso Impurity
Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·24V789000·2024-10-23
Kenworth and Peterbilt fuel pump barrels may fracture and leak
PACCAR is recalling certain 2025 Kenworth and Peterbilt trucks with Cummins X15 diesel engines because the fuel pump barrels may fracture and cause a fuel leak.
Product
KENWORTH — KENWORTH, PETERBILT W900, 579, T680, C500
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2025·2024-10-23
Cue Health COVID-19 Test Cartridge Recalled for Unapproved Distribution
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
Product
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V792000·2024-10-23
Mack trucks with Bendix EC80 units may lose safety system functions
Mack is recalling certain 2020-2025 trucks with Bendix EC80 Advanced Electronic Control Units because electrical noise may cause the ECU to misprocess commands or stop working.
Product
MACK — MACK PINNACLE (PI/PN), ANTHEM (AN), GRANITE (GR), PIONEER PR (4)
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0101-2025·2024-10-23
AVVIGO+ Medical Imaging System Grid Overlay Display Software Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalitie
Category
Medical Device
Distribution
Distributed nationwide
ModerateNHTSA·24T012000·2024-10-23
Michelin Recalls Specialty Tires Missing DOT Certification Markings
Michelin is recalling certain XVS and TRX specialty tires provided as replacements for a prior recall because they lack the required DOT certification symbol on the sidewalls.
Product
TIRES:MARKINGS recall
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0032-2025·2024-10-23
Great Value Mixed Fruits Variety Pack Recalled for Undeclared Food Dye
Walmart is recalling Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack because FD&C Red No. 3 was not declared on the label. The recall affects 511,164 units distributed nationwide.
Product
Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack, 4 oz, 12 Pack
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0033-2025·2024-10-23
Great Value Cherry Mixed Fruit Recalled for Undeclared Food Colorant
Walmart is recalling Great Value Cherry Mixed Fruit cups nationwide because FD&C Red No 3 was not declared as an ingredient on the label.
Product
Great Value Cherry Mixed Fruit, 4 oz, 4 Count and 12 count plastic cups sealed with clear film.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0109-2025·2024-10-23
Boston Scientific AVVIGO+ Medical Device Grid Overlay Display Error
Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0120-2025·2024-10-23
Medline Heart Overhead Table Pack recalled for incorrect model labeling
Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.
Product
MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0103-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that displays an incorrect grid overlay during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0116-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance Systems Due to Software Display Error
Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0115-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System because a software error displays the wrong grid overlay during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0098-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System because a software anomaly causes an incorrect grid overlay to display during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which inc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0123-2025·2024-10-23
Medical Device Kit Incorrectly Labeled With Wrong Model Number
Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.
Product
MEDLINE KIT CV I II, REF DYNJ906071B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0112-2025·2024-10-23
Medical imaging system software defect causes incorrect grid overlay display
Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide