Recalls in Hawaii (page 5)
3886 recalls.
- BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM... recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - Alphenix INFX-8000C/B5 recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported October 14, 2026 · Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and... - ABD HYSTERECTOMY recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - GYN LAPAROSCOPY PACK recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - MAJOR PACK recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - UROLOGY MAJOR recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - HEART PREP TRAY recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - DAVINCI LAP/GYN recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - PLASTICS TRAY recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - LAPAROSCOPIC PROSTATECTOMY recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - ROBOTIC PROSTATECTOMY PACK recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - PACK OPEN HEART CFH recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - CRANIOTOMY PACK recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - ENDOVASCULAR PACK recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - ADULT HEART TRAY SHANDS JACKS recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - GYN LAPAROSCOPY/LAPAROTOMY recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - DAVINCI TRUCUSTOM BUNDLE recall (AVID Medical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Product may be potentially contaminated with a lubricant used during the manufacturing process. - Onkos Surgical Inc. My3D Personalized Pelvic Implant recall (Onkos Surgical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. - Onkos Surgical Inc. My3D Personalized Pelvic Implant recall (Onkos Surgical, Inc.)
Medical deviceClass IIReported October 14, 2026 · Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. - Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog... recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported October 14, 2026 · Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed... - Rollator recall (Medline Industries, LP)
Medical deviceClass IIReported October 14, 2026 · The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator... - Rollator recall (Medline Industries, LP)
Medical deviceClass IIReported October 14, 2026 · The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator... - BARD EP XT DECAPOLAR STEERABLE recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported October 14, 2026 · Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to... - DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE recall (Beckman Coulter Inc.)
Medical deviceClass IIReported October 14, 2026 · Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical... - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE recall (Beckman Coulter Inc.)
Medical deviceClass IIReported October 14, 2026 · Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical... - Sperm Ab ELISA recall (DRG International, Inc.)
Medical deviceClass IIReported October 14, 2026 · Potential for false negative patient results. - Glypto Device recall (Limitless Cryo Spa LLC)
Medical deviceClass IIReported October 14, 2026 · Lack of 510(k) clearance. - HALYARD Laparoscopy Comprehensive Pack II REF: 49332 recall (GRI Medical & Electronic Technology Co., Ltd.)
Medical deviceClass IIReported October 14, 2026 · Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter - Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient... recall (QUANTUM OPS Inc)
Medical deviceClass IIReported October 14, 2026 · Due to a manufacturing issue (inadequate weld) for patient head positioning system. - VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 recall (Steris Corporation)
Medical deviceClass IIReported October 14, 2026 · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization... - VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 recall (Steris Corporation)
Medical deviceClass IIReported October 14, 2026 · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization... - VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061 recall (Steris Corporation)
Medical deviceClass IIReported October 14, 2026 · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization... - VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060 recall (Steris Corporation)
Medical deviceClass IIReported October 14, 2026 · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization... - VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 recall (Steris Corporation)
Medical deviceClass IIReported October 14, 2026 · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization... - VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 recall (Steris Corporation)
Medical deviceClass IIReported October 14, 2026 · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization... - The Conqueror Recalls Avengers Medals Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Magnets
Consumer productReported October 8, 2026 · The recalled medals violate the mandatory safety standard for magnets because the high-powered magnets may detach, posing a deadly ingestion hazard to... - Snow Peak Recalls Propane Fireplace Inserts and Lava Rocks Due to Risk of Serious Injury or Death from Burn and Fire Hazards
Consumer productReported October 8, 2026 · The fireplace's lava rocks can ignite and explode when heated in the propane insert, posing a risk of serious injury or death from burn and fire hazards. - Romorgniz Recalls Six-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported October 8, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Pacearth Direct Recalls PACEARTH Swing Seats Due to Risk of Serious Injury from Fall Hazard
Consumer productReported October 8, 2026 · The seats, metal carabiners or quick links, or webbing straps of the recalled swing seats can break during use, posing a risk of serious injury due to fall... - ONTHEWEI Recalls Baby Bath Seats Due to Risk of Serious Injury or Death to Children from Drowning; Violate Mandatory Standard for Infant Bath Seats
Consumer productReported October 8, 2026 · The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious... - Decathlon America Recalls Van Rysel GRVL AF Bicycles Due to Risk of Serious Injury or Death from Crash Hazard
Consumer productReported October 8, 2026 · The recalled bicycles' front lock nut can loosen during use, causing the front wheel to dislodge or loosen over time, posing a crash hazard. - DR Power Equipment Recalls Pilot and Premier Trimmer Mowers Due to Risk of Serious Injury or Death from Fire and Burn Hazards
Consumer productReported October 8, 2026 · Grass and debris can accumulate in the trimmer mowers and ignite, posing a risk of serious injury or death from fire and burn hazards. - Giant Bicycle Recalls LED-Light Keys Included with SureLock Bike Lock Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries
Consumer productReported October 8, 2026 · The LED-light key that was included with certain SureLock Bicycle Lock sets violates the mandatory safety standard for consumer products with button cell and... - Organiccs Absolutely Pure recall (Pacific Health Sciences Llc)
FoodClass IIReported October 7, 2026 · Undeclared shellfish (crab shell): source of ingredient Glucosamine sulfate - Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER... recall (Beckman Coulter Mishima K.K.)
Medical deviceClass IIReported October 7, 2026 · Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError... - Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)
Medical deviceClass IIReported October 7, 2026 · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter... - Travel Air recall (Percussionaire Corporation)
Medical deviceClass IIReported October 7, 2026 · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter... - Impulsator recall (Percussionaire Corporation)
Medical deviceClass IIReported October 7, 2026 · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter... - Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)
Medical deviceClass IIReported October 7, 2026 · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter... - Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)
Medical deviceClass IIReported October 7, 2026 · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter... - In-Line Valve recall (Percussionaire Corporation)
Medical deviceClass IIReported October 7, 2026 · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter... - Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)
Medical deviceClass IIReported October 7, 2026 · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter... - Fisher Scientific Sure-Vue Urine hCG recall (Alere San Diego, Inc.)
Medical deviceClass IIReported October 7, 2026 · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. - Fisher Scientific Sure-Vue Urine hCG Strip recall (Alere San Diego, Inc.)
Medical deviceClass IIReported October 7, 2026 · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. - Fisher Scientific Sure-Vue Serum/Urine hCG recall (Alere San Diego, Inc.)
Medical deviceClass IIReported October 7, 2026 · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. - McKesson CONSULT hCG Urine Cassette recall (Alere San Diego, Inc.)
Medical deviceClass IIReported October 7, 2026 · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. - Todd's Seeds Variety Pack of Sprouting Seeds - Broccoli recall (TODD'S SEEDS LLC)
FoodClass IReported October 7, 2026 · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) - Todd's Seeds Alfalfa & Mung Bundle recall (TODD'S SEEDS LLC)
FoodClass IReported October 7, 2026 · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) - Todd's Seeds Salad Sprouting Mixture - Broccoli recall (TODD'S SEEDS LLC)
FoodClass IReported October 7, 2026 · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) - Todd's Seeds Sprouting Seed Mix - Broccoli recall (TODD'S SEEDS LLC)
FoodClass IReported October 7, 2026 · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) - Todd's Seeds Broccoli & Friends Sprouting Seed Mix - Broccoli recall (TODD'S SEEDS LLC)
FoodClass IReported October 7, 2026 · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) - Todd's Seeds Alfalfa Sprouting Seeds recall (TODD'S SEEDS LLC)
FoodClass IReported October 7, 2026 · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) - Paroxetine Extended-Release Tablets recall (Apotex Corp.)
DrugClass IIReported October 7, 2026 · Failed dissolution specifications. - Buprenorphine Hydrochloride recall (Par Health USA, LLC)
DrugClass IIReported October 7, 2026 · Crystallization - Zoladex recall (TerSera Therapeutics LLC)
DrugClass IIReported October 7, 2026 · Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. - Estradiol Gel recall (Amneal Pharmaceuticals, LLC)
DrugClass IIReported October 7, 2026 · Defective Container; packets were found to be either empty or partially full. - Ranolazine Extended-Release Tablets recall (Ajanta Pharma USA Inc)
DrugClass IIReported October 7, 2026 · Failed Dissolution Specifications: below specification - Atellica CH Revised C-Reactive Protein recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported October 7, 2026 · The potential for falsely elevated results. - CHARLOTTE CLAW Screw recall (Wright Medical Technology, Inc.)
Medical deviceClass IIReported October 7, 2026 · Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads... - HOPKINS Telescope 30¿ recall (Karl Storz Endoscopy)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect inside packaging label for eyepiece. - Brand Name: Penumbra System recall (Penumbra Inc.)
Medical deviceClass IIReported October 7, 2026 · Due to manufacturing issues reperfusion catheters may fracture. - Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application recall (Tandem Diabetes Care, Inc.)
Medical deviceClass IIReported October 7, 2026 · A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application... - Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported October 7, 2026 · While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable. - Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger... recall (SPECTRUM MEDICAL SRL)
Medical deviceClass IIReported October 7, 2026 · Due to blood-to-glycol leak in the heat exchanger. - Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger... recall (SPECTRUM MEDICAL SRL)
Medical deviceClass IIReported October 7, 2026 · Due to blood-to-glycol leak in the heat exchanger. - Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code:... recall (Micro Therapeutics, Inc.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter. - Evolution upgrade 1.5T amd Evolution upgrade 3.0T recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - Upgrade to MR 7700 recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - Upgrade dStream recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - SmartPath to MR 7700 recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - SmartPath to dStream for 1.5T recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - MR 7700 recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - MR 5300 recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - Ingenia Elition S and Ingenia Elition X. recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - Ingenia Ambition S and Ingenia Ambition X. recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - Ingenia 3.0T and 3.0T CX recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - Ingenia 1.5T recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - Ingenia Blue Seal SE and Blue Seal XE recall (Philips North America)
Medical deviceClass IIReported October 7, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion... - NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I. recall (NOXBOX LTD)
Medical deviceClass IIReported October 7, 2026 · Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors. - Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported October 7, 2026 · Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the... - PALACOS MV pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported October 7, 2026 · Potential for monomer liquid leakage. - PALACOS MV+G pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported October 7, 2026 · Potential for monomer liquid leakage. - PALACOS R+G pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported October 7, 2026 · Potential for monomer liquid leakage. - PALACOS R pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported October 7, 2026 · Potential for monomer liquid leakage. - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported October 7, 2026 · The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece... - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported October 7, 2026 · The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece... - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported October 7, 2026 · The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece... - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported October 7, 2026 · The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece... - Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary... recall (American Contract Systems Inc)
Medical deviceClass IIReported October 7, 2026 · Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the...