Product Recalls in Hawaii

Product recalls affecting Hawaii — including food, drugs, consumer products, medical devices, and vehicles distributed to Hawaii. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,424 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,424 in last 12 months

Showing 1832118340 of 47,764 recalls

Medical DeviceFebruary 14, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q.zen Biplane Recalled by Siemens Medical Solutions USA, Inc Due to A...

The Issue: A software issue could potentially cause the stand and table movements to be...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 14, 2020· Micro Therapeutics Inc, Dba Ev3 Neurovascular

Recalled Item: ev3 Pipeline Flex Embolization Device. For neurological endovascular use....

The Issue: Embolization device delivery system may fracture at the distal section...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 14, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q Biplane Recalled by Siemens Medical Solutions USA, Inc Due to A...

The Issue: A software issue could potentially cause the stand and table movements to be...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
FoodFebruary 14, 2020· Custom Foods LLC

Recalled Item: Sticky Fingers Bakeries Gluten-Free Scones Recalled by Custom Foods LLC Due...

The Issue: Firm received customer inquiry of why wheat is listed in the ingredient list...

Recommended Action: Do not consume. Return to store for a refund or discard.

Class III — Low RiskOngoing
Refund
Medical DeviceFebruary 14, 2020· ICU Medical, Inc.

Recalled Item: The Cogent Hemodynamic Monitoring System. Recalled by ICU Medical, Inc. Due...

The Issue: Firm identified software issues which leads to the patient ID and patient...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Merit Medical Systems, Inc.

Recalled Item: DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly Recalled by Merit...

The Issue: Vertebral hydraulic assemblies has incorrect expiration date printed on the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Merit Medical Systems, Inc.

Recalled Item: DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly Recalled by...

The Issue: Vertebral hydraulic assemblies has incorrect expiration date printed on the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro...

The Issue: Bilirubin assays may exhibit a positive bias with patients on eltrombopag...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· NuVasive Inc

Recalled Item: NUVASIVE MAGEC 2 Rod X.X mm XX mm Recalled by NuVasive Inc Due to...

The Issue: Post-implantation separation of an actuator end cap component that may...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Insulet Corporation

Recalled Item: Omnipod DASH Personal Diabetes Manager (PDM) Recalled by Insulet Corporation...

The Issue: In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & Recalled by...

The Issue: Bilirubin assays may exhibit a positive bias with patients on eltrombopag...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for...

The Issue: Bilirubin assays may exhibit a positive bias with patients on eltrombopag...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the...

The Issue: Bilirubin assays may exhibit a positive bias with patients on eltrombopag...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the Recalled by...

The Issue: Bilirubin assays may exhibit a positive bias with patients on eltrombopag...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114...

The Issue: Bilirubin assays may exhibit a positive bias with patients on eltrombopag...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 12, 2020· Microbiologics Inc

Recalled Item: Microbiologics QC SETS AND PANELS Recalled by Microbiologics Inc Due to...

The Issue: KWIKSTIK 2 Pack () and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 12, 2020· Microbiologics Inc

Recalled Item: KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog#...

The Issue: KWIKSTIK 2 Pack () and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 12, 2020· Boston Scientific Corporation

Recalled Item: Boston Scientific Recalled by Boston Scientific Corporation Due to Boston...

The Issue: Boston Scientific released a new Software Update Application that was...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 12, 2020· Boston Scientific Corporation

Recalled Item: Boston Scientific Recalled by Boston Scientific Corporation Due to Boston...

The Issue: Boston Scientific released a new Software Update Application that was...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
DrugFebruary 12, 2020· Lupin Pharmaceuticals Inc.

Recalled Item: Memantine Hydrochloride Extended Release Capsules Recalled by Lupin...

The Issue: Failed Dissolution Specifications: Low out of specification results observed...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund