Product Recalls in South Carolina

Product recalls affecting South Carolina — including food, drugs, consumer products, medical devices, and vehicles distributed to South Carolina. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,679 recalls have been distributed to South Carolina in the last 12 months.

51,854 total recalls
2,679 in last 12 months

Showing 1090110920 of 28,688 recalls

Medical DeviceOctober 12, 2020· MEDTRONIC ATS MEDICAL, INC.

Recalled Item: Cardioblate CryoFlex Recalled by MEDTRONIC ATS MEDICAL, INC. Due to There is...

The Issue: There is a potential defect in the seals of the sterile barrier pouch used...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2020· Talladium Inc

Recalled Item: Luminesse ML PMMA Recalled by Talladium Inc Due to Heat-cured...

The Issue: Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make...

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

Class III — Low RiskOngoing
Medical DeviceOctober 9, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: cobas infinity central lab/cobas infinity core license-The cobas infinity IT...

The Issue: Potential Incorrect Validation of Results Due to an Erroneous QC Status When...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation standalone software treatment planning system Recalled by...

The Issue: If a region of interest (ROI) or point of interest (POI) that is from an...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· Canon Medical System, USA, INC.

Recalled Item: CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Recalled by...

The Issue: There is a potential that the cable of the Flat panel detector may break...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· Enterix, Inc.

Recalled Item: InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT)...

The Issue: Product does not meet internal testing criterion; use of the product may...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· Microbiologics Inc

Recalled Item: Catalog 02145P Recalled by Microbiologics Inc Due to Strain should be VIM-1...

The Issue: Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2020· Steris Corporation

Recalled Item: Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning...

The Issue: Potential for cleaning solution intrusion into endoscope

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

Class III — Low RiskOngoing
Medical DeviceOctober 6, 2020· Arjohuntleigh Magog, Inc.

Recalled Item: Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used Recalled by...

The Issue: Risk of Sling Clip breakage while in use with obsolete Flat Dynamic...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 6, 2020· Exactech, Inc.

Recalled Item: Catalog 314-13-23 Recalled by Exactech, Inc. Due to Mislabeling

The Issue: The product may be mislabeled.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 6, 2020· Exactech, Inc.

Recalled Item: Catalog 314-13-33 Recalled by Exactech, Inc. Due to Mislabeling

The Issue: The product may be mislabeled.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Recalled by Becton,...

The Issue: Recent product complaints showing an unexpected cell population exhibiting...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Thera Test Laboratories, Inc.

Recalled Item: EL-Anti-SARS-CoV-2 IgG Kit Recalled by Thera Test Laboratories, Inc. Due to...

The Issue: The cross-reactivity of the device may present an increased level of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Micro-Tech Usa

Recalled Item: Elastic Traction Device Recalled by Micro-Tech Usa Due to FDA has informed...

The Issue: FDA has informed Micro-Tech that the Elastic Traction Device is not...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Bayer Medical Care, Inc.

Recalled Item: Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic...

The Issue: Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Tytek Medical Inc

Recalled Item: TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge Recalled by Tytek...

The Issue: Updated IFU to inlclude: (1) identify the risks associated with the hazard...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Tytek Medical Inc

Recalled Item: TyTek PneumoDart- Intended for introduction into the body to facilitate...

The Issue: Updated IFU to inlclude: (1) identify the risks associated with the hazard...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Tytek Medical Inc

Recalled Item: TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Recalled by...

The Issue: Updated IFU to inlclude: (1) identify the risks associated with the hazard...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2020· Microbiologics Inc

Recalled Item: LYFO DISK(TM) Recalled by Microbiologics Inc Due to Potential E. coli...

The Issue: Potential contamination with Escherichia coli, Staphylococcus epidermidis...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2020· Microbiologics Inc

Recalled Item: QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Recalled by...

The Issue: Potential contamination with Escherichia coli Staphylococcus epidermidis and...

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

Class II — Potential Health HazardOngoing