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. 2,452 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,452 in last 12 months

Showing 1694116960 of 27,558 recalls

Medical DeviceJuly 13, 2017· Medtronic Vascular Galway DBA Medtronic Ireland

Recalled Item: Solarice Rapid Exchange Balloon Dilatation Catheter Recalled by Medtronic...

The Issue: Stylette removal difficulties on the Euphora and Solarice products.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 13, 2017· Pentax of America Inc

Recalled Item: Video Cystoscope models ECY-1570 and ECY-1570K Recalled by Pentax of America...

The Issue: The video cytoscopes lack 510(k) premarket notification clearance.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 13, 2017· Bios S.r.l.

Recalled Item: THERMI250 Radiofrequency System. Intended to provide heating for the purpose...

The Issue: In some systems, the unit continues to emit RF energy after the PAUSE button...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 13, 2017· Microline Surgical, Inc.

Recalled Item: The ReNew Reusable Grasper and Dissector Tips are to be Recalled by...

The Issue: The heat-shrink insulation tube may split during autoclave...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 13, 2017· Medtronic Vascular Galway DBA Medtronic Ireland

Recalled Item: Euphora Rapid Exchange Balloon Dilatation Catheter Recalled by Medtronic...

The Issue: Stylette removal difficulties on the Euphora and Solarice products.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 11, 2017· Olympus Scientific Solutions Americas

Recalled Item: Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA...

The Issue: Instruments may, under certain specific circumstances listed below, fail to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 11, 2017· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT - Model 728306 Computed Tomography X-ray systems Recalled by...

The Issue: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 11, 2017· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT SP - Model 728311 Brilliance iCT - Model Recalled by Philips...

The Issue: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 7, 2017· Qualigen Inc

Recalled Item: Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit Recalled...

The Issue: Specific lots have been reported to produce falsely lower than expected...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 7, 2017· Ondamed Inc

Recalled Item: Ondamed Biofeedback Device Recalled by Ondamed Inc Due to The firm was...

The Issue: The firm was marketing the Ondamed System in the US without marketing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2017· Edwards Lifesciences, LLC

Recalled Item: Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product...

The Issue: The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2017· Novo Nordisk Inc

Recalled Item: Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product...

The Issue: A small number of batches may crack or break if exposed to certain...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2017· Teleflex Medical

Recalled Item: LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600...

The Issue: Teleflex Medical is recalling the affected product because there may be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2017· Roche Diagnostics Corporation

Recalled Item: Roche / Hitachi MODULAR Analyzer Systems-Immunoassay...

The Issue: A software malfunction can occur on the cobas e 411 and Elecsys 2010...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2017· Roche Diagnostics Corporation

Recalled Item: cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number:...

The Issue: A software malfunction can occur on the cobas e 411 and Elecsys 2010...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2017· Phadia US Inc

Recalled Item: Phadia 1000 Instrument Recalled by Phadia US Inc Due to The "Retry" command...

The Issue: The "Retry" command does not function properly which could cause a shortage...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2017· Cosman Medical, LLC

Recalled Item: Nitinol TC Reusable Electrodes (TCN) Recalled by Cosman Medical, LLC Due to...

The Issue: After multiple reprocessing cycles, the epoxy resin which holds the TCN...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 30, 2017· Alcon Research, Ltd.

Recalled Item: ORA System with VerifEye Recalled by Alcon Research, Ltd. Due to Some ORA...

The Issue: Some ORA Carts have the potential to return an incorrect IOL power...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 30, 2017· Sorin Group USA, Inc.

Recalled Item: STOCKERT Heater-Cooler System 3T Recalled by Sorin Group USA, Inc. Due to...

The Issue: Plastic heat exchanger fibers separating the blood compartment from the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 30, 2017· Elekta, Inc.

Recalled Item: MOSAIQ Medical Charged-Particle Radiation Therapy System Recalled by Elekta,...

The Issue: The table shift in the vertical direction was inverted during the use of CMA...

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

Class II — Potential Health HazardOngoing