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 2234122360 of 27,558 recalls

Medical DeviceJanuary 7, 2015· GE Healthcare

Recalled Item: This correction applies to all GE Healthcare MRI systems with Recalled by GE...

The Issue: At certain sites, the MRU may not be connected to the magnet. In emergency...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 7, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings Recalled by...

The Issue: Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 5, 2015· Arrow International Inc

Recalled Item: ARROW Epidural Needle Component (product number AN-05501). Epidural needles...

The Issue: The product labeling does not specify the 5 year shelf life of the product.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 5, 2015· Clinical Innovations, LLC

Recalled Item: The Ebb Complete Tamponade System Recalled by Clinical Innovations, LLC Due...

The Issue: Clinical Innovations, LLC is voluntarily recalling the Ebb Complete...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 2, 2015· Natus Medical Incorporated

Recalled Item: EPWorks software used in the Xltek Protektor Stimulator Product Usage:...

The Issue: Software error occurs when using remote monitoring; if the remote user tries...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 2, 2015· Arrow International Inc

Recalled Item: ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The...

The Issue: Foreign material found within the kits. The foreign material, white or black...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 2, 2015· Natus Medical Incorporated

Recalled Item: EPWorks software used in the Protektor 32 Product Usage: Uses Recalled by...

The Issue: Software error occurs when using remote monitoring; if the remote user tries...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Clinical Innovations, LLC

Recalled Item: Ebb Complete Tamponade System Recalled by Clinical Innovations, LLC Due to...

The Issue: Potential for a balloon leak in all lots of (CTS-1000) manufactured since...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDLab 1245 System Recalled by Siemens Healthcare Diagnostics Inc Due to...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDPoint 405 Blood Gas Analyzer Recalled by Siemens Healthcare Diagnostics...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDLab 1265 System Recalled by Siemens Healthcare Diagnostics Inc Due to...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 30, 2014· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDPoint 500 Blood Gas Analyzer Recalled by Siemens Healthcare Diagnostics...

The Issue: Neonatal bilirubin (nBili) parameter may have increased variability when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 29, 2014· Baxter Corporation Englewood

Recalled Item: Baxter Recalled by Baxter Corporation Englewood Due to Self-Righting Luer...

The Issue: Self-Righting Luer Tip Caps were manufactured and shipped with a missing...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 29, 2014· Ortho-Clinical Diagnostics

Recalled Item: VITROS Hand-held Barcode Scanner Recalled by Ortho-Clinical Diagnostics Due...

The Issue: In combination with the Batch Programming option (only) for programming...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 29, 2014· Dick's Sporting Goods

Recalled Item: Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG) Recalled...

The Issue: Reports of customers falling from the Inversion Table and sustaining...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Cardinal Health

Recalled Item: Lubricated Intubating Stylet 6FR that is inserted into an endotracheal...

The Issue: A small piece of the stylet sheath has the potential to shear off upon...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Therasage, LLC.

Recalled Item: Portable FAR Infrared Sauna Indications including Recalled by Therasage,...

The Issue: Product distributed without 510(k) approval

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Therasage, LLC.

Recalled Item: FAR-Infrared Heat Home Sauna Recalled by Therasage, LLC. Due to Product...

The Issue: Product distributed without 510(k) approval

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Philips Medical Systems, Inc.

Recalled Item: HeartStart MRx monitor/defibrillator Models M3535A Recalled by Philips...

The Issue: MRx monitor/defibrillator could reboot at an indeterminate time, potentially...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 23, 2014· Therasage, LLC.

Recalled Item: FAR-Infrared Heat Home Sauna Recalled by Therasage, LLC. Due to Product...

The Issue: Product distributed without 510(k) approval

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

Class II — Potential Health HazardOngoing