Product Recalls in South Dakota

Product recalls affecting South Dakota — including food, drugs, consumer products, medical devices, and vehicles distributed to South Dakota. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,491 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,491 in last 12 months

Showing 1140111420 of 27,558 recalls

Medical DeviceJune 22, 2020· Biosense Webster (israel), Ltd.

Recalled Item: CARTO 3 System (Software Version V7.1.80) Recalled by Biosense Webster...

The Issue: Software defect may result in disapperance of tag sites during recalculation...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2020· GE Healthcare, LLC

Recalled Item: CARESCAPE ONE Recalled by GE Healthcare, LLC Due to CARESCAPE ONE may not...

The Issue: CARESCAPE ONE may not provide visual and audible alarms for Ventricular...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 20, 2020· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: Computed Tomography X-ray System Recalled by Shanghai United Imaging...

The Issue: The metal edge overlap of the mylar strip in the gantry was uneven, which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 20, 2020· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: Computed Tomography X-ray System Recalled by Shanghai United Imaging...

The Issue: The metal edge overlap of the mylar strip in the gantry was uneven, which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 20, 2020· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: Computed Tomography X-ray System Recalled by Shanghai United Imaging...

The Issue: The metal edge overlap of the mylar strip in the gantry was uneven, which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 19, 2020· Argon Medical Devices, Inc

Recalled Item: ClosureFast Micro Introducer Sheath Set Recalled by Argon Medical Devices,...

The Issue: Sterile introducer sheath set manufactured under one lot with different...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 19, 2020· Abbott Gmbh & Co. KG

Recalled Item: Alinity ci series System Control Module (SCM) Recalled by Abbott Gmbh & Co....

The Issue: Quality Control results were not properly evaluated for QC failures.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Chembio Diagnostics, Inc

Recalled Item: Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 Recalled by Chembio...

The Issue: FDA revocation of the Emergency Use Authorization due to performance issues

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Chembio Diagnostics, Inc

Recalled Item: Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for...

The Issue: FDA revocation of the Emergency Use Authorization due to performance issues

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Chembio Diagnostics, Inc

Recalled Item: Chembio DPP¿ Micro Reader II for use with the DPP¿ Recalled by Chembio...

The Issue: FDA revocation of the Emergency Use Authorization due to performance issues

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Anjon Holdings

Recalled Item: Anjon Bremer Molded Crown. bone fixation fastener for spinal use. Recalled...

The Issue: High rate of galling of one threaded component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 18, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal Recalled by...

The Issue: Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2020· Beckman Coulter Biomedical GmbH

Recalled Item: DxA 5000 Recalled by Beckman Coulter Biomedical GmbH Due to The DxA 5000...

The Issue: The DxA 5000 instructions for use may be confusing regarding the re-use of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2020· Resource Optimization & Innovation LLC

Recalled Item: regard Migrating Indicator Recalled by Resource Optimization & Innovation...

The Issue: The firm received reports from customer that the Regard Migrating Indicator...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2020· FHC, Inc.

Recalled Item: FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Recalled by FHC,...

The Issue: An electrical sub-circuit was not properly connected. Its purpose is to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset Recalled by CME America, LLC Due to Infusion...

The Issue: Infusion administration sets may have a delivery inaccuracy over plus/minus...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset With Female Luer Recalled by CME America, LLC Due to...

The Issue: Infusion administration sets may have a delivery inaccuracy over plus/minus...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset Recalled by CME America, LLC Due to Infusion...

The Issue: Infusion administration sets may have a delivery inaccuracy over plus/minus...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 16, 2020· CME America, LLC

Recalled Item: BodyGuard BodySet Recalled by CME America, LLC Due to Infusion...

The Issue: Infusion administration sets may have a delivery inaccuracy over plus/minus...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset Recalled by CME America, LLC Due to Infusion...

The Issue: Infusion administration sets may have a delivery inaccuracy over plus/minus...

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

Class I — Serious Health HazardOngoing