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. 2,812 recalls have been distributed to North Carolina in the last 12 months.

54,363 total recalls
2,812 in last 12 months

Showing 37613780 of 29,737 recalls

Medical DeviceJune 7, 2024· Randox Laboratories Ltd.

Recalled Item: RX Series CYSC- Cystatin C Reagent -Intended for in vitro Recalled by Randox...

The Issue: Cystatin C Reagent marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 7, 2024· Rygel Advanced Machines d/b/a Omtech Laser

Recalled Item: OMTech Desktop Laser Engraver Recalled by Rygel Advanced Machines d/b/a...

The Issue: Lack of redundant interlocks, missing required labels and certification...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 5, 2024· Beckman Coulter Mishima K.K.

Recalled Item: DxC 500 AU Clinical Chemistry Analyzer Recalled by Beckman Coulter Mishima...

The Issue: There are two software bug issues with the analyzer. Issue 1: When a...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 5, 2024· Philips North America Llc

Recalled Item: SENSE XL TORSO COIL 1.5T. 16-element receive only coil for Recalled by...

The Issue: Potential for coils to heat up and harm patients (burn).

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 5, 2024· Philips North America Llc

Recalled Item: SENSE XL TORSO COIL 3.0T. 16-element receive only coil for Recalled by...

The Issue: Potential for coils to heat up and harm patients (burn).

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 5, 2024· Philips North America Llc

Recalled Item: SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil Recalled by...

The Issue: Potential for coils to heat up and harm patients (burn).

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 4, 2024· Beckman Coulter, Inc.

Recalled Item: Dxl 9000 Access Immunoassay Analyzer Recalled by Beckman Coulter, Inc. Due...

The Issue: The analyzers were built with nonconforming USB cables made with brass...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2024· Zyno Medical LLC

Recalled Item: Zyno Medical Z800 Recalled by Zyno Medical LLC Due to Zyno Medical has found...

The Issue: Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Microtek Medical Inc.

Recalled Item: Bag Decanter II Recalled by Microtek Medical Inc. Due to During sterile...

The Issue: During sterile barrier testing performed on the decanter product line, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Microtek Medical Inc.

Recalled Item: Vial Decanter Recalled by Microtek Medical Inc. Due to During sterile...

The Issue: During sterile barrier testing performed on the decanter product line, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Microtek Medical Inc.

Recalled Item: Bottle Decanter Recalled by Microtek Medical Inc. Due to During sterile...

The Issue: During sterile barrier testing performed on the decanter product line, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Microtek Medical Inc.

Recalled Item: C-Flow Bag Decanter Recalled by Microtek Medical Inc. Due to During sterile...

The Issue: During sterile barrier testing performed on the decanter product line, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Microtek Medical Inc.

Recalled Item: Transfer Device Recalled by Microtek Medical Inc. Due to During sterile...

The Issue: During sterile barrier testing performed on the decanter product line, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Qiagen Sciences LLC

Recalled Item: QIAcube Connect MDx - IVD Instrument designed to perform automated Recalled...

The Issue: Heater shaker module does not perform heating if the temperature is set...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: RTL190395: 2008K@HOME MACHINE Recalled by Fresenius Medical Care Holdings,...

The Issue: An increased number of complaints were reported on the Blood Pump Rotor (P/N...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: RTLR190395: 2008K@HOME MACHINE Recalled by Fresenius Medical Care Holdings,...

The Issue: An increased number of complaints were reported on the Blood Pump Rotor (P/N...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part...

The Issue: An increased number of complaints were reported on the Blood Pump Rotor (P/N...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: 190395: 2008K@HOME MACHINE Recalled by Fresenius Medical Care Holdings, Inc....

The Issue: An increased number of complaints were reported on the Blood Pump Rotor (P/N...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part...

The Issue: An increased number of complaints were reported on the Blood Pump Rotor (P/N...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 3, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare...

The Issue: An increased number of complaints were reported on the Blood Pump Rotor (P/N...

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

Class II — Potential Health HazardOngoing