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 2236122380 of 27,558 recalls

Medical DeviceDecember 22, 2014· Cordis Corporation

Recalled Item: Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses...

The Issue: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Flyte Togas are components of the Stryker Flyte System and Recalled by...

The Issue: A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number...

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

Class III — Low RiskOngoing
Medical DeviceDecember 19, 2014· SpineFrontier, Inc.

Recalled Item: lnline Persuader- PedFuse Pedicle Screw System Recalled by SpineFrontier,...

The Issue: A crack may develop in the handle to the Inline Persuader, which may...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Siemens Medical Solutions USA, Inc

Recalled Item: LINAC Accelerators: ARTISTE Recalled by Siemens Medical Solutions USA, Inc...

The Issue: A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Sunrise Medical (US) LLC

Recalled Item: Quickie Q7 Adult Rigid Wheelchair Model EIR4. Recalled by Sunrise Medical...

The Issue: There is the potential for the height adjustable handle to dislodge due to...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Becton Dickinson & Company

Recalled Item: BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula Recalled by...

The Issue: The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Fresenius Kabi USA, LLC

Recalled Item: HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION Recalled by Fresenius Kabi USA, LLC...

The Issue: The lot failed pH specification.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Integra LifeSciences Corporation

Recalled Item: The MAYFIELD¿ Ultra 360 Base Unit for head positioner Recalled by Integra...

The Issue: Through an investigation of complaints, Integra found that there is the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Sunrise Medical (US) LLC

Recalled Item: Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. Recalled by Sunrise...

The Issue: There is the potential for the height adjustable handle to dislodge due to...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· BD Biosciences, Systems & Reagents

Recalled Item: CD8 (Leu-2a) PE (In vitro diagnostic) Recalled by BD Biosciences, Systems &...

The Issue: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· BD Biosciences, Systems & Reagents

Recalled Item: Anti-Lambda APC-H7 Recalled by BD Biosciences, Systems & Reagents Due to Two...

The Issue: Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Philips Medical Systems, Inc.

Recalled Item: Philips IntelliVue Information Center iX (release A.00 Recalled by Philips...

The Issue: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Elekta, Inc.

Recalled Item: Monaco radiation therapy treatment planning system. The Monaco system is...

The Issue: Incorrect CT to ED when using the Monaco Image Statistics Tool.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Synthes, Inc.

Recalled Item: Synthes Electric Pen Drive (EPD) System Recalled by Synthes, Inc. Due to In...

The Issue: In May 2013, the original recall was initiated due to complaints the Hand...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 19, 2014· Elekta, Inc.

Recalled Item: Focal Sim radiation therapy treatment planning system Recalled by Elekta,...

The Issue: Incorrect CT to ED when using the Monaco Image Statistics Tool.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Sysmex Corporation

Recalled Item: The XN-Series modules (XN-10 Recalled by Sysmex Corporation Due to There is...

The Issue: There is a potential for elevated hemoglobin (Hgb) and impedance platelet...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Spinal Elements, Inc

Recalled Item: Ti-Bond Marketing Literature/Labeling Recalled by Spinal Elements, Inc Due...

The Issue: Spinal Elements is recalling the Ti-Bond related brochures that includes...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· St Jude Medical Cardiac Rhythm Management Division

Recalled Item: Merlin@home RF Remote Monitoring Transmitter Recalled by St Jude Medical...

The Issue: Transmitter may initiate a software reset resulting in backup operation in...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Ziemer Usa Inc

Recalled Item: Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform...

The Issue: The devices were not shipped with the Starter Kits.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2014· Roche Diagnostics Operations, Inc.

Recalled Item: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Recalled...

The Issue: Chemical component of the F3 Fluid pack and environmental bacterial...

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

Class II — Potential Health HazardOngoing