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 1116111180 of 28,688 recalls

Medical DeviceAugust 31, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001...

The Issue: Potential for Fluid leaks within the instruments, creating an electrical...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Number: IEDAT6 Recalled by Biomet...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Ultradent Products, Inc.

Recalled Item: PermaFlo Flowable Composite 948 Shade: A2 - Product Usage: Recalled by...

The Issue: Due to a potential manufacturing issue (cross contamination), composite is...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TIN ABUTMENT 5.0MM Number: IEDAN5 Recalled by Biomet 3i,...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope...

The Issue: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k)...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Greiner Bio-One North America, Inc.

Recalled Item: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator Recalled by Greiner...

The Issue: Blood collection tubes experienced an issue with separation and clotting

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens epoc BGEM Test Card-In vitro diagnostic device for the Recalled by...

The Issue: Sporadically inconsistent discrepant (low bias) glucose results on card lot...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 27, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: Albumin Gen.2 Recalled by Roche Diagnostics Operations, Inc. Due to Roche...

The Issue: Roche has confirmed customer complaints of low quality (QC) recovery and...

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

Class III — Low RiskOngoing
Medical DeviceAugust 27, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: Tina-quant Complement C4 ver.2 Recalled by Roche Diagnostics Operations,...

The Issue: Roche has confirmed customer complaints of low quality (QC) recovery and...

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

Class III — Low RiskOngoing
Medical DeviceAugust 26, 2020· ev3 Inc.

Recalled Item: Pacific Xtreme (PTCA Balloon Dilation Catheter) Recalled by ev3 Inc. Due to...

The Issue: Labeling discrepancy for the Rated Burst Pressure (RBP) value.

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 26, 2020· Beckman Coulter Inc.

Recalled Item: BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol...

The Issue: Due to alkaline phosphatase (ALP) associated interference causing falsely...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge -...

The Issue: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM HER-2/neu (H2n) assay Recalled by Siemens Healthcare...

The Issue: Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Genicon, Inc.

Recalled Item: Aquas PowerFlow Tube Set - Product Usage: The device delivers Recalled by...

The Issue: The product design incorporating a motor driven impeller pump powered by one...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK...

The Issue: Internal testing at the supplier, revealed that a crimped wire was placed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32 Recalled...

The Issue: Internal testing at the supplier, revealed that a crimped wire was placed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32 Recalled...

The Issue: Internal testing at the supplier, revealed that a crimped wire was placed...

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

Class II — Potential Health HazardOngoing