Product Recalls in North Carolina

Product recalls affecting North Carolina — including food, drugs, consumer products, medical devices, and vehicles distributed to North Carolina. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,789 recalls have been distributed to North Carolina in the last 12 months.

54,363 total recalls
2,789 in last 12 months

Showing 87018720 of 29,737 recalls

Medical DeviceJanuary 14, 2022· Stryker Corporation

Recalled Item: 1688 Camera Control Unit (CCU) Recalled by Stryker Corporation Due to A...

The Issue: A software defect in the camera control unit (CCU) will cause the image on...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2022· Sunstar Americas, Inc.

Recalled Item: BUTLER Clear Dip Recalled by Sunstar Americas, Inc. Due to Product lacks...

The Issue: Product lacks premarket clearance.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2022· Lusys Laboratories, Inc.

Recalled Item: LuSys 2nd Generation of COVID-19 Viral Antigen Test For all Recalled by...

The Issue: COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 13, 2022· Nextremity Solutions

Recalled Item: Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone...

The Issue: During insertion of the middle phalanx implant into bone, the driver may...

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

Class II — Potential Health HazardOngoing
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
Medical DeviceJanuary 13, 2022· Lusys Laboratories, Inc.

Recalled Item: Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For...

The Issue: COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 13, 2022· Lusys Laboratories, Inc.

Recalled Item: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and Recalled by...

The Issue: COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 13, 2022· K2M, Inc

Recalled Item: Everest MI XT Inner 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
Medical DeviceJanuary 13, 2022· Nextremity Solutions

Recalled Item: Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone...

The Issue: During insertion of the middle phalanx implant into bone, the driver may...

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

Class II — Potential 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 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: 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 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 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
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· Shimadzu Medical Systems

Recalled Item: MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 Recalled by Shimadzu Medical Systems...

The Issue: It was found that the irradiated x-ray may exceed the xray radiation dose...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 10, 2022· Shimadzu Medical Systems

Recalled Item: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 Recalled by Shimadzu Medical...

The Issue: It was found that the irradiated x-ray may exceed the xray radiation dose...

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

Class II — Potential Health HazardOngoing