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. 2,512 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,512 in last 12 months

Showing 1302113040 of 47,764 recalls

Medical DeviceJanuary 13, 2022· K2M, Inc

Recalled Item: Everest MI XT Outer Dilator Recalled by K2M, Inc Due to Stryker received two...

The Issue: Stryker received two (2) complaints for units from specific lots of Inner...

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

Class II — Potential Health HazardOngoing
DrugJanuary 12, 2022· Ascend Laboratories, LLC

Recalled Item: Metoprolol Succinate Extended-Release Tablets Recalled by Ascend...

The Issue: Failed Dissolution Specifications.

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

Class II — Potential Health HazardOngoing
Refund
DrugJanuary 11, 2022· Exela Pharma Sciences LLC

Recalled Item: 8.4% Sodium Bicarbonate Injection Recalled by Exela Pharma Sciences LLC Due...

The Issue: Lack of Assurance of Sterility

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: 5 Fr. X 65 cm Arrow-Trerotola PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) Recalled by...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) Recalled by...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
DrugJanuary 10, 2022· Teva Pharmaceuticals USA

Recalled Item: Tretinoin Capsules Recalled by Teva Pharmaceuticals USA Due to Failed...

The Issue: Failed Dissolution Specifications; Low Out of specification (OOS) results...

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

Class II — Potential Health HazardOngoing
Refund
DrugJanuary 10, 2022· Ingenus Pharmaceuticals Llc

Recalled Item: Clobetasol Propionate Foam Recalled by Ingenus Pharmaceuticals Llc Due to...

The Issue: CGMP Deviations

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

Class II — Potential Health HazardOngoing
Refund
DrugJanuary 10, 2022· Dr. Reddy's Laboratories, Inc.

Recalled Item: Mucus Relief D Recalled by Dr. Reddy's Laboratories, Inc. Due to Subpotent drug

The Issue: Subpotent drug

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

Class III — Low RiskOngoing
Refund
Medical DeviceJanuary 10, 2022· BASE 10 GENETICS INC

Recalled Item: RNAstill Molecular Transport Medium Vial Recalled by BASE 10 GENETICS INC...

The Issue: The product does not have 510(k) clearance.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 10, 2022· Compass Health Brands (Corporate Office)

Recalled Item: Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx...

The Issue: Wheel spoke may crack causing the wheel to separate from the axle may result...

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

Class II — Potential Health HazardOngoing
DrugJanuary 7, 2022· Teva Pharmaceuticals USA

Recalled Item: Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg...

The Issue: Mislabeling

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

Class III — Low RiskOngoing
Refund
DrugJanuary 7, 2022· Teva Pharmaceuticals USA

Recalled Item: Mimvey (estradiol and norethindrone acetate tablets USP) Recalled by Teva...

The Issue: Mislabeling

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

Class III — Low RiskOngoing
Refund
DrugJanuary 7, 2022· VistaPharm, Inc.

Recalled Item: Clobazam Oral Suspension 2.5 mg/mL Recalled by VistaPharm, Inc. Due to...

The Issue: Failed Stability Specifications

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceJanuary 7, 2022· Orthosoft, Inc. dba Zimmer CAS

Recalled Item: NavitrackER Kit A: Knee Recalled by Orthosoft, Inc. dba Zimmer CAS Due to...

The Issue: The product was released for distribution without passing sterilization...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 7, 2022· Biomet, Inc.

Recalled Item: Comprehensive Shoulder System Primary Shoulder Stem Recalled by Biomet, Inc....

The Issue: The products in scope underwent an incorrect rework operation for the porous...

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

Class II — Potential Health HazardOngoing