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. 2,785 recalls have been distributed to North Carolina in the last 12 months.

54,363 total recalls
2,785 in last 12 months

Showing 95219540 of 29,737 recalls

Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent....

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Recalled...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Recalled by...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 9, 2021· Copan Italia

Recalled Item: COPAN FLOQSwabs Recalled by Copan Italia Due to A sterility assurance level...

The Issue: A sterility assurance level of 10-6 cannot be guaranteed due to intentional...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· PROCEPT BIOROBOTICS CORPORATION

Recalled Item: AQUABEAM Handpiece Recalled by PROCEPT BIOROBOTICS CORPORATION Due to Scope...

The Issue: Scope tube tip may detach from the telescoping tube, which is attached to a...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Ortho8, Inc.

Recalled Item: CIRCUL8 LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to CIRCUL8...

The Issue: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Ortho8, Inc.

Recalled Item: EVEXIA LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to EVEXIA...

The Issue: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Argon Medical Devices, Inc

Recalled Item: Scorpion Portal Vein Access Set - Product Usage: used to Recalled by Argon...

The Issue: As a result of design changes, sheaths have exhibited cracking/breaking at...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Carl Zeiss Meditec, Inc.

Recalled Item: Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX Recalled...

The Issue: Due to failure to acquire pre-market clearance for its high resolution...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 7, 2021· Baxter Healthcare Corporation

Recalled Item: Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recalled by...

The Issue: Software issue: The defect creates a mismatch between linked drug...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit ()- Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Advance Dx, Inc.

Recalled Item: Advance Dx 100 Blood Collection Card Quantity 25 Recalled by Advance Dx,...

The Issue: Due to high glucose test results when using the blood collection cards.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2021· Zeltiq Aesthetics, Inc

Recalled Item: CoolSculpting Elite System The CoolSculpting System SW release 2.0 Recalled...

The Issue: An incorrect error messaging system that could potentially lead to: 1)...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 2, 2021· Hero Health

Recalled Item: The Hero Model 100 (H-100) is a system consisting of Recalled by Hero Health...

The Issue: Due to dispenser prompting for a missed dose that had already been dispensed

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Gibson Bioscience

Recalled Item: Potassium Hydroxide 10% (KOH 10%) Recalled by Gibson Bioscience Due to A lot...

The Issue: A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.

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

Class II — Potential Health HazardOngoing