Recalls in Hawaii (page 7)
3886 recalls.
- nGenuity Patient Monitor with Capnography recall (Criticare Technologies, Inc.)
Medical deviceClass IIReported September 30, 2026 · Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. - ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The... recall (Becton, Dickinson and Company)
Medical deviceClass IIReported September 30, 2026 · Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. - Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black... recall (GIAS FOOD INC.)
FoodClass IReported September 30, 2026 · Contamination with Listeria monocytogenes - So Delicious Dairy Free Salted Caramel Cluster Cashewmilk recall (WWF Operating Company)
FoodClass IIReported September 30, 2026 · Product may contain foreign material: small stones and other hard objects. - Clear Eyes Redness Relief recall (Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Clear Eyes Redness Relief recall (Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Exenatide Injection recall (Amneal Pharmaceuticals of New York, LLC)
DrugClass IIReported September 30, 2026 · Defective Delivery System: Possibility of no medication in the prefilled pen. - Olanzapine Tablets recall (Macleods Pharmaceuticals Limited)
DrugClass IIIReported September 30, 2026 · Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. - AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Lubricant Eye Drops-Cameron Pharmaceuticals recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Major LubriFresh P.M. Nighttime Ointment recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Reliable-1 Laboratories Lubricating Tears recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Walgreens Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Walgreens Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Reliable -1 Laboratories recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Medline Convenience Kits: 1) ANTERIOR SPINE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 30, 2026 · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present... - Medline Convenience Kits: 1) MAJOR NEURO VCH recall (Medline Industries, LP)
Medical deviceClass IIReported September 30, 2026 · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present... - Medline Convenience Kits: 1) MFC CRANIOTOMY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 30, 2026 · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present... - Medline Convenience Kits: 1) MAJOR PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 30, 2026 · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present... - Medline Convenience Kits: 1) PEDS SINUS PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 30, 2026 · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present... - PRO+ 40" MRS SURFACE recall (Baxter Healthcare Corporation)
Medical deviceClass IIReported September 30, 2026 · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved... - PRO+ 36" MRS SURFACE recall (Baxter Healthcare Corporation)
Medical deviceClass IIReported September 30, 2026 · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved... - PRO+ MRS SURFACE FOR VERSACARE recall (Baxter Healthcare Corporation)
Medical deviceClass IIReported September 30, 2026 · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved... - Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 30, 2026 · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. - Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 30, 2026 · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. - New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall (New York Embroidery Studio, Inc.)
Medical deviceClass IIReported September 30, 2026 · Gowns do not consistently meet the minimum liquid-barrier performance required. - Cardioroot Woven Collagen Coated Vascular Graft recall (INTERVASCULAR, SAS)
Medical deviceClass IIReported September 30, 2026 · Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). - Brand Name: VOLARA System Product Name: VOLARA recall (Baxter Healthcare Corporation)
Medical deviceClass IIReported September 30, 2026 · Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and... - REF: 81-030415 Myocardial Probe Non-Pyrogenic recall (DeRoyal Industries Inc)
Medical deviceClass IIReported September 30, 2026 · Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. - Presource Convenience Kits: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported September 30, 2026 · The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could... - Presource Convenience Kits: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported September 30, 2026 · The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could... - Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall (Philips Ultrasound, LLC)
Medical deviceClass IIReported September 30, 2026 · Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood... - Brand Name: Pearle Vision 1 day Product Name: recall (CooperVision, Inc.)
Medical deviceClass IIReported September 30, 2026 · A small number of lenses within the affected lot are of the incorrect power. - Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported September 30, 2026 · Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. - Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported September 30, 2026 · Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. - Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported September 30, 2026 · Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. - Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported September 30, 2026 · Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. - SmartPath to dStream for 1.5T recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - MR 7700 and Upgrade to MR 7700 recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - MR 5300 Model Number recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Name recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Ingenia Elition S and Ingenia Elition X recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Ingenia 3.0T and Ingenia 3.0T CX recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Ingenia Ambition S and Ingenia Ambition X recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Ingenia 1.5T recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Evolution upgrade 1.5T and Evolution upgrade 3.0T recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Achieva XR recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Achieva 3.0T recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Achieva 1.5T recall (Philips North America Llc)
Medical deviceClass IIReported September 30, 2026 · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction... - Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS... recall (Medline Industries, LP)
Medical deviceClass IIReported September 30, 2026 · Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush.... - Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK... recall (Medline Industries, LP)
Medical deviceClass IIReported September 30, 2026 · Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush.... - SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head recall (SEASPINE ORTHOPEDICS CORPORATION)
Medical deviceClass IIReported September 30, 2026 · The proximal thread depth of the spinal device is out of design specification. - CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors recall (Fresenius Medical Care Renal Therapies Group, LLC)
Medical deviceClass IIReported September 30, 2026 · Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. - PowerLED 300 Concealed Lighting System recall (Maquet SAS)
Medical deviceClass IIReported September 30, 2026 · The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. - REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post... recall (Ventec Life Systems, Inc.)
Medical deviceClass IIReported September 30, 2026 · Labeling; Oxygen Cylinders do not contain required medical gas labeling - REF:HF2PC9 HomeFill Oxygen System recall (Ventec Life Systems, Inc.)
Medical deviceClass IIReported September 30, 2026 · Labeling; Oxygen Cylinders do not contain required medical gas labeling - HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve recall (Ventec Life Systems, Inc.)
Medical deviceClass IIReported September 30, 2026 · Labeling; Oxygen Cylinders do not contain required medical gas labeling - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIReported September 30, 2026 · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. - Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module ... recall (Heidelberg Engineering GmbH)
Medical deviceClass IIReported September 30, 2026 · Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a... - Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall (Boston Scientific Corporation)
Medical deviceClass IReported September 30, 2026 · Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged... - Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)
Medical deviceClass IReported September 30, 2026 · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. - INCA recall (CooperSurgical, Inc.)
Medical deviceClass IReported September 30, 2026 · Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP... - INCA recall (CooperSurgical, Inc.)
Medical deviceClass IReported September 30, 2026 · Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP... - ABC Trading Recalls Light-Up Children’s Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported September 24, 2026 · The recalled children’s toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that hold the batteries... - Love To Dream Recalls Portable Sleep Machines Due to Risk of Injury from Fire and Burn Hazards
Consumer productReported September 24, 2026 · The lithium-ion battery in the recalled portable sleep machines can overheat if the charger is not compatible with the unit, posing a risk of injury from fire... - INMO International Technology Limited Recalls INMO Air3 Smart Glasses Due to Risk of Serious Injury or Death from Burn Hazard
Consumer productReported September 24, 2026 · The left temple of the recalled smart glasses can overheat during extended use, posing a risk of serious injury or death due to burn hazard. - Style Homeware Recalls Emerspring Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
Consumer productReported September 24, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - Yuyitop Recalls Aitjunz 8-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 September 24, 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... - Xinan Home Recalls WinxMatrs Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
Consumer productReported September 24, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - NEWDERY Power Banks Recalled Due to Fire and Burn Hazards; Risk of Serious Injury; Sold on Amazon
Consumer productReported September 24, 2026 · The lithium-ion battery in the power banks can explode or ignite, posing fire and burn hazards to consumers. - The Blue Cactus Company Reclining Chair Battery Packs Recalled Due to Fire and Burn Hazards; Sold on Amazon
Consumer productReported September 24, 2026 · The lithium-ion battery in the recalled battery packs can overheat, posing fire and burn hazards to consumers. - Hyperfuels Recalls Methanol and Ethanol Fuel Containers Due to Risk of Serious Injury or Death from Child Poisoning and Flame Jetting; Violates Multiple Federal Safety Standards
Consumer productReported September 24, 2026 · The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under... - 5Color Recalls Children’s Bicycle Helmet and Pads Sets Due to Risk of Serious Injury or Death from Head Injury; Violate Mandatory Standard for Bicycle Helmets
Consumer productReported September 24, 2026 · The helmets in the recalled sets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation... - ZCK01 Recalls Kesyup Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
Consumer productReported September 24, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - Boston Scientific Corporation StoneSmart Connect Console Contents: recall (Boston Scientific Corporation)
Medical deviceClass IIReported September 23, 2026 · A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power... - REF:B5ST Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:B5LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:B12LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:B11LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:2B5ST Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - REF:2B5LT Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported September 23, 2026 · Reusable access port system may crack or seperate during use. - Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT... recall (Wilson-Cook Medical Inc.)
Medical deviceClass IIReported September 23, 2026 · Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). - Happiest Baby recall (Happiest Baby, Inc)
Medical deviceClass IIReported September 23, 2026 · Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. - Happiest Baby recall (Happiest Baby, Inc)
Medical deviceClass IIReported September 23, 2026 · Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Oncology sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Oncology sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Non-Dedicated Gravity Administration Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Plum administration sets recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Philips PIC iX Essentials REF:867093 recall (Philips North America)
Medical deviceClass IIReported September 23, 2026 · Due to software malfunction, patient information system may freeze and become unresponsive. - Philips Patient Information Center iX REF:866389 recall (Philips North America)
Medical deviceClass IIReported September 23, 2026 · Due to software malfunction, patient information system may freeze and become unresponsive. - BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump... recall (BD SWITZERLAND SARL)
Medical deviceClass IReported September 23, 2026 · Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.