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. 1,920 recalls have been distributed to North Carolina in the last 12 months.

54,363 total recalls
1,920 in last 12 months

Showing 2244122460 of 29,737 recalls

Medical DeviceNovember 3, 2015· Diagnostic Hybrids, Inc.

Recalled Item: MicroVue SC5b-9 Plus EIA (RUO) Recalled by Diagnostic Hybrids, Inc. Due to A...

The Issue: A component of the kit was found to contain bacterial contamination.

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

Class III — Low RiskOngoing
Medical DeviceNovember 3, 2015· Diagnostic Hybrids, Inc.

Recalled Item: MicroVue SC5b-9 Plus EIA (CE-IVD) Recalled by Diagnostic Hybrids, Inc. Due...

The Issue: A component of the kit was found to contain bacterial contamination.

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

Class III — Low RiskOngoing
Medical DeviceNovember 3, 2015· Diagnostic Hybrids, Inc.

Recalled Item: MicroVue CIC-C1q EIA Recalled by Diagnostic Hybrids, Inc. Due to A component...

The Issue: A component of the kit was found to contain bacterial contamination.

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

Class III — Low RiskOngoing
Medical DeviceNovember 2, 2015· Insulet Corporation

Recalled Item: OmniPod¿ Recalled by Insulet Corporation Due to Pod's needle mechanism fails...

The Issue: Pod's needle mechanism fails to deploy or there is a delay in the deployment...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 2, 2015· Insulet Corporation

Recalled Item: OmniPod¿ Recalled by Insulet Corporation Due to Pod's needle mechanism fails...

The Issue: Pod's needle mechanism fails to deploy or there is a delay in the deployment...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 2, 2015· Trumpf Medical Systems, Inc.

Recalled Item: Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted...

The Issue: The firm has received 15 complaints over ten years related to the connection...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 30, 2015· BioHorizons Implant Systems Inc

Recalled Item: RBT Recalled by BioHorizons Implant Systems Inc Due to An incorrect label...

The Issue: An incorrect label reading 10.5mm and not the specified 15mm was placed...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· NxStage Medical, Inc.

Recalled Item: NxStage System One S Cycler (High Permeability Hemodialysis System) Model...

The Issue: Ultrafiltration (UF) Volume software error inaccurate fluid removal

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core Computed Tomography X-ray system Recalled by Philips Medical...

The Issue: Perfusion scan feature may not be available on machines running software...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity CT Computed Tomography X-ray system Recalled by Philips Medical...

The Issue: Perfusion scan feature may not be available on machines running software...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core 128 Computed Tomography X-ray system Recalled by Philips...

The Issue: Perfusion scan feature may not be available on machines running software...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT Computed Tomography X-ray system Recalled by Philips Medical...

The Issue: Perfusion scan feature may not be available on machines running software...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 64 Computed Tomography X-ray system Recalled by Philips Medical...

The Issue: Perfusion scan feature may not be available on machines running software...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT SP Computed Tomography X-ray system Recalled by Philips...

The Issue: Perfusion scan feature may not be available on machines running software...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2015· NxStage Medical, Inc.

Recalled Item: NxStage System One S Cycler (High Permeability Hemodialysis System) Model...

The Issue: Ultrafiltration (UF) Volume software error inaccurate fluid removal

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo Imaging VB36D_HF02. Radiological image processing system. Recalled by...

The Issue: To provide supplementary information regarding the release of the syngo...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· Medtronic Perfusion Systems

Recalled Item: Medtronic Perfusion Tubing Packs Recalled by Medtronic Perfusion Systems Due...

The Issue: This recall is being initiated due to a potential breach of the Tubing Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· Implant Direct Sybron Manufacturing, LLC

Recalled Item: DGDE Recalled by Implant Direct Sybron Manufacturing, LLC Due to Implant...

The Issue: Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· Baylis Medical Corp *

Recalled Item: ProTrack Microcatheter. Model/Catalog Numbers CIC38-145 Recalled by Baylis...

The Issue: Microcatheter may have circumferential defects (cracks) along its shaft.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· BC Group International Inc

Recalled Item: DA-2006P - Defibrillator / Pacer Analyzer Recalled by BC Group International...

The Issue: Device is not functioning as intended: Two wires running to the ECG...

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

Class III — Low RiskOngoing