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. 2,562 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,562 in last 12 months

Showing 49414960 of 27,645 recalls

Medical DeviceDecember 11, 2023· Ethicon Endo-Surgery Inc

Recalled Item: ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST)...

The Issue: There is the potential for incomplete staple line formation during the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· Globus Medical, Inc.

Recalled Item: Globus Medical Cranial Drill Recalled by Globus Medical, Inc. Due to...

The Issue: Sterile-packed Cranial Drills may not be sterile due to a breach in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· Getinge Usa Sales Inc

Recalled Item: Flow-i C20 Anesthesia System Recalled by Getinge Usa Sales Inc Due to...

The Issue: Potential cybersecurity vulnerability that could lead to a Denial of Service...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· Globus Medical, Inc.

Recalled Item: Globus Medical Cranial Drill with Stop Recalled by Globus Medical, Inc. Due...

The Issue: Sterile-packed Cranial Drills may not be sterile due to a breach in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· Getinge Usa Sales Inc

Recalled Item: Flow-e Anesthesia System Recalled by Getinge Usa Sales Inc Due to Potential...

The Issue: Potential cybersecurity vulnerability that could lead to a Denial of Service...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· Getinge Usa Sales Inc

Recalled Item: Flow-i C30 Anesthesia System Recalled by Getinge Usa Sales Inc Due to...

The Issue: Potential cybersecurity vulnerability that could lead to a Denial of Service...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· Globus Medical, Inc.

Recalled Item: Globus Medical Cranial Drill with Stop Recalled by Globus Medical, Inc. Due...

The Issue: Sterile-packed Cranial Drills may not be sterile due to a breach in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· Getinge Usa Sales Inc

Recalled Item: Flow-c Anesthesia System Recalled by Getinge Usa Sales Inc Due to Potential...

The Issue: Potential cybersecurity vulnerability that could lead to a Denial of Service...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2023· RONAN MEDICAL LLC

Recalled Item: BrainFeedback Pro 2 Device - is intended as an instrument Recalled by RONAN...

The Issue: Neurofeedback systems removed due to missing design and development...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 8, 2023· WAVi Co.

Recalled Item: WAVi Research EEG Desktop System is comprised of the WAVi Recalled by WAVi...

The Issue: Following an FDA-issued Warning Letter, the firm requested return of their...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 8, 2023· PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recalled Item: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Recalled by...

The Issue: Loss of connectivity between the FlexArm and the Table due to a software...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 8, 2023· Olympus Corporation of the Americas

Recalled Item: Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Recalled by...

The Issue: Single Use Distal Cover MAJ-2315 may unexpectedly detach from the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 8, 2023· Megadyne Medical Products, Inc.

Recalled Item: Product Code 0845 Recalled by Megadyne Medical Products, Inc. Due to...

The Issue: Affected product codes are now limited to use in patients age 12 years or...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 8, 2023· Megadyne Medical Products, Inc.

Recalled Item: Product Code 0848 Recalled by Megadyne Medical Products, Inc. Due to...

The Issue: Affected product codes are now limited to use in patients age 12 years or...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 8, 2023· PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recalled Item: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Recalled by...

The Issue: Loss of connectivity between the FlexArm and the Table due to a software issue.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 8, 2023· Megadyne Medical Products, Inc.

Recalled Item: Product Code 0847 Recalled by Megadyne Medical Products, Inc. Due to...

The Issue: Affected product codes are now limited to use in patients age 12 years or...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 8, 2023· Megadyne Medical Products, Inc.

Recalled Item: Product Code 0846 Recalled by Megadyne Medical Products, Inc. Due to...

The Issue: Affected product codes are now limited to use in patients age 12 years or...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 7, 2023· Medtronic Inc.

Recalled Item: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator Recalled by...

The Issue: During internal review of Polaris battery assembly data from the HiPot...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 7, 2023· TERRAGENE S.A.

Recalled Item: Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco...

The Issue: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 7, 2023· TERRAGENE S.A.

Recalled Item: Terragene Bionova PCD (PCD222-C) Recalled by TERRAGENE S.A. Due to Due to a...

The Issue: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and...

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

Class II — Potential Health HazardOngoing