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. 2,386 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,386 in last 12 months

Showing 2134121360 of 27,558 recalls

Medical DeviceJune 22, 2015· Volcano Corporation

Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...

The Issue: A software issue was discovered where an inaccurate FFR/iFR value could be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2015· Draeger Medical, Inc.

Recalled Item: Fabius MRI Anesthesia Machine Recalled by Draeger Medical, Inc. Due to the...

The Issue: the Fabius MRI or parts of the system were attracted by the magnetic field...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2015· Volcano Corporation

Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...

The Issue: A software issue was discovered where an inaccurate FFR/iFR value could be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2015· Volcano Corporation

Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...

The Issue: A software issue was discovered where an inaccurate FFR/iFR value could be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2015· Nobel Biocare Usa Llc

Recalled Item: Abutment Retrieval Instrument Zirconia CC RP/WP Recalled by Nobel Biocare...

The Issue: One dimension of the affected instrument is incorrect. Therefore this...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2015· Volcano Corporation

Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...

The Issue: A software issue was discovered where an inaccurate FFR/iFR value could be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2015· Volcano Corporation

Recalled Item: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3...

The Issue: A software issue was discovered where an inaccurate FFR/iFR value could be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 19, 2015· CooperSurgical, Inc.

Recalled Item: Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Recalled...

The Issue: Incorrect expiration date on outer carton kit label

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2015· Philips Electronics North America Corporation

Recalled Item: Invivo Expression MRI Patient Monitoring System. Recalled by Philips...

The Issue: The device's labeling inaccurately indicates Endotracheal as a body...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2015· Biomet, Inc.

Recalled Item: A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument....

The Issue: Medium Bone Plate Forceps was assembled with the incorrect grip arm tip....

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2015· Acon Laboratories, Inc.

Recalled Item: Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Recalled by Acon...

The Issue: Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to...

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

Class III — Low RiskOngoing
Medical DeviceJune 16, 2015· Intuitive Surgical, Inc.

Recalled Item: INSTRUMENT ARM DRAPE Recalled by Intuitive Surgical, Inc. Due to Field...

The Issue: Field Safety Notification to advise of an issue that may occur involving the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2015· Sorin Group USA, Inc.

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

The Issue: Potential colonization of organisms, including Mycobacteria, in Sorin Heater...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2015· Sorin Group USA, Inc.

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

The Issue: Potential colonization of organisms, including Mycobacteria, in Sorin Heater...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2015· Etac Supply Center Ab

Recalled Item: Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable...

The Issue: The Supporter toilet armrest has two Fast Nuts fixing the product to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2015· Sorin Group USA, Inc.

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

The Issue: Potential colonization of organisms, including Mycobacteria, in Sorin Heater...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2015· 3M Company - Health Care Business

Recalled Item: Block Versions Used by Dental Offices often to as Recalled by 3M Company -...

The Issue: 3M is initiating a Field Correction to remove the crown indication from all...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2015· BD Biosciences, Systems & Reagents

Recalled Item: BD Flow Cytometers Recalled by BD Biosciences, Systems & Reagents Due to...

The Issue: Instruments installed between June 2007 and September 2011 do not contain...

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

Class III — Low RiskOngoing
Medical DeviceJune 15, 2015· Sorin Group USA, Inc.

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

The Issue: Potential colonization of organisms, including Mycobacteria, in Sorin Heater...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2015· Abbott Point Of Care Inc.

Recalled Item: i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged...

The Issue: Certain lots of PT/INR cartridges may generate a higher than typical number...

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

Class II — Potential Health HazardOngoing