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. 2,391 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,391 in last 12 months

Showing 2210122120 of 47,764 recalls

Medical DeviceFebruary 26, 2019· Biomet 3i, LLC

Recalled Item: CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM Recalled by Biomet 3i, LLC Due to...

The Issue: During manufacturing, the screw stop ledge was not made to specification and...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2019· Biomet 3i, LLC

Recalled Item: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM Recalled by Biomet 3i, LLC...

The Issue: During manufacturing, the screw stop ledge was not made to specification and...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2019· Biomet 3i, LLC

Recalled Item: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM Recalled by Biomet 3i, LLC...

The Issue: During manufacturing, the screw stop ledge was not made to specification and...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2019· Biomet 3i, LLC

Recalled Item: CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM Recalled by Biomet 3i, LLC Due to...

The Issue: During manufacturing, the screw stop ledge was not made to specification and...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2019· Biomet 3i, LLC

Recalled Item: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM Recalled by Biomet 3i, LLC...

The Issue: During manufacturing, the screw stop ledge was not made to specification and...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2019· Abbott Gmbh & Co. KG

Recalled Item: Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: Recalled by...

The Issue: The safety interlock covering the septum piercing probes within the bulk...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2019· Abbott Gmbh & Co. KG

Recalled Item: Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: Recalled by...

The Issue: The safety interlock covering the septum piercing probes within the bulk...

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

Class II — Potential Health HazardOngoing
DrugFebruary 25, 2019· Macleods Pharma Usa Inc

Recalled Item: Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg Recalled by Macleods...

The Issue: Failed Content Uniformity Specifications: The product is out of...

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

Class II — Potential Health HazardOngoing
Refund
DrugFebruary 25, 2019· Macleods Pharma Usa Inc

Recalled Item: Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg Recalled by...

The Issue: Failed Content Uniformity Specifications: The product is out of...

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

Class II — Potential Health HazardOngoing
Refund
DrugFebruary 25, 2019· Macleods Pharma Usa Inc

Recalled Item: Telmisartan and Hyrdochlorothiazide Tablets Recalled by Macleods Pharma Usa...

The Issue: Failed Content Uniformity Specifications: The product is out of...

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceFebruary 25, 2019· Nidek, Inc.

Recalled Item: NIDEK Specular Microscope Recalled by Nidek, Inc. Due to The electromagnetic...

The Issue: The electromagnetic noise exceeded the upper limit of the Electromagnetic...

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

Class III — Low RiskOngoing
Medical DeviceFebruary 25, 2019· Cook Medical Incorporated

Recalled Item: Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein...

The Issue: Updates to the Instructions for Use.

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

Class III — Low RiskOngoing
Medical DeviceFebruary 25, 2019· Cook Medical Incorporated

Recalled Item: Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach Recalled...

The Issue: Updates to the Instructions for Use.

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

Class III — Low RiskOngoing
Medical DeviceFebruary 25, 2019· Cook Medical Incorporated

Recalled Item: Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach...

The Issue: Updates to the Instructions for Use.

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

Class III — Low RiskOngoing
Medical DeviceFebruary 25, 2019· Cook Medical Incorporated

Recalled Item: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Recalled by...

The Issue: Updates to the Instructions for Use.

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

Class III — Low RiskOngoing
Medical DeviceFebruary 25, 2019· Cook Medical Incorporated

Recalled Item: Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach Recalled...

The Issue: Updates to the Instructions for Use.

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

Class III — Low RiskOngoing
Medical DeviceFebruary 25, 2019· Cook Medical Incorporated

Recalled Item: Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach Recalled by...

The Issue: Updates to the Instructions for Use.

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

Class III — Low RiskOngoing
DrugFebruary 22, 2019· Golean Detox US

Recalled Item: Golean DETOX capsules Recalled by Golean Detox US Due to Undeclared Sibutramine

The Issue: Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain...

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

Class I — Serious Health HazardOngoing
Refund
DrugFebruary 22, 2019· Akorn, Inc.

Recalled Item: Gentamicin Sulfate Ophthalmic Solution Recalled by Akorn, Inc. Due to Failed...

The Issue: Failed Impurities/Degradation Specifications: High Out-of-Specification...

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

Class II — Potential Health HazardOngoing
Refund
DrugFebruary 22, 2019· Ascend Laboratories LLC

Recalled Item: Tamsulosin Hydrochloride Capsules Recalled by Ascend Laboratories LLC Due to...

The Issue: Failed Dissolution Specifications: High Out-of-Specification dissolution...

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

Class II — Potential Health HazardOngoing
Refund