State

Hawaii product recalls

73,509 recalls have nationwide distribution and so reach Hawaii. 2,772 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total: 2,772
Critical: 333
Severe: 715
Most recent: 2026-10-14

Of the 2,772 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 715 (26%) are Severe.

Which agencies issued them

These figures cover only the 2,772 recalls whose distribution notice names Hawaii specifically. The 73,509 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

23551–23575 of 76281

HighFDA (Devices)·Z-0165-2022·2021-11-03
GORE Cardioform Septal Occluder recalled for incorrect expiration date labeling
W.L. Gore is recalling 138 units of GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the actual 2-year shelf life.
Product
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0181-2022·2021-11-03
Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
Product
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V853000·2021-11-03
Loose Brake Pipe Nut in 2022 Volkswagen Tiguan Vehicles
Volkswagen is recalling 2022 Tiguan vehicles with a loose brake pipe nut near the right-front wheel well. The loose nut could cause brake fluid to leak, reducing braking power and increasing crash risk.
Product
VOLKSWAGEN — VOLKSWAGEN TIGUAN
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2022·2021-11-03
Siemens Atellica CH Protein Reagent Recalled for Carryover Affecting Test Results
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V852000·2021-11-03
2021 Volkswagen ID.4 Steering Gear Defect Poses Loss of Control Risk
Volkswagen is recalling one 2021 ID.4 vehicle with a defective steering gear. A missing or incorrectly assembled drive bushing may cause loss of steering control and increase crash risk.
Product
VOLKSWAGEN — VOLKSWAGEN ID.4
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2022·2021-11-03
GORE CARDIOFORM Septal Occluder devices labeled with incorrect expiration date
W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.
Product
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0176-2022·2021-11-03
ASC PneumoLiner surgical device recalled due to manufacturing orientation defect
Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.
Product
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V855000·2021-11-03
Rolls-Royce Recalls Phantom Vehicles Due to Rearview Camera Display Issue
Rolls-Royce is recalling 2019-2022 Phantom vehicles because the central display may not raise correctly, partially blocking the rearview camera image.
Product
ROLLS-ROYCE — ROLLS-ROYCE PHANTOM
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2022·2021-11-03
Xstrahl Concerto Software Fails to Update Opposing Beam Treatment Parameters
Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.
Product
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0001-2022·2021-11-03
RAPTAR Laser Range Finders Recalled for Field Modification Safety Risk
Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.
Product
RAPTAR Laser Range Finders
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2022·2021-11-03
Septal Occluder Devices Recalled for Incorrect Expiration Date Label
W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.
Product
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
Category
Medical Device
Distribution
47 states
HighCPSC·22016·2021-11-03
Usines Giant Factories Gas Water Heaters Recalled for Carbon Monoxide Risk
Usines Giant Factories is recalling about 168 gas water heaters with Emerson control valves that can short circuit, overheat, and release carbon monoxide. The company will replace the control valve free of charge.
Product
Usines Giant Factories Gas Water Heaters with Emerson control valves
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2022·2021-11-03
Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date
W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.
Product
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0177-2022·2021-11-03
Bivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.
Product
Bivona Aire-Cuf Endotracheal Tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2022·2021-11-03
Bivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.
Product
Bivona Uncuffed Wire Endotracheal Tubes,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2022·2021-11-03
GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.
Product
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0175-2022·2021-11-03
Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results
AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.
Product
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0079-2022·2021-11-03
Rizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities
Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0172-2022·2021-11-03
Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.
Product
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
Category
Medical Device
Distribution
47 states
ModerateCPSC·22015·2021-11-03
Elektron BP-1 Power Handles Recalled for Fire and Burn Hazards
Elektron Power Handle BP-1 units can short circuit and overheat, creating fire and burn risks. Consumers should stop using them immediately and contact Elektron for a full refund.
Product
Elektron BP-1 Power Handles
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0091-2022·2021-11-03
Gatifloxacin Ophthalmic Solution Recalled for Failed Stability Tests
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to failed water loss tests that may affect drug concentration. The recall affects 16,272 bottles distributed nationwide.
Product
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0077-2022·2021-11-03
Afassco Pain Free Plus X-Strength Tablets Recalled for Failed Stability
Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.
Product
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0078-2022·2021-11-03
Rizatriptan Benzoate Tablets Recall Due to Out-of-Specification Impurities
MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.
Product
RIZATRIPTAN — RIZATRIPTAN (RIZATRIPTAN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0076-2022·2021-11-03
Xpect First Aid Extra Strength Pain Away tablets recalled for failed stability specifications
Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away tablets nationwide due to out-of-specification results for Salicylic Acid, a compound related to Aspirin, indicating failed stability testing.
Product
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0075-2022·2021-11-03
Advance Formula Pain Reliever tablets recalled for failed stability specifications
Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for Salicylic Acid, an Aspirin-related compound.
Product
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561…
Category
Drug
Distribution
Distributed nationwide