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. 1,670 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
1,670 in last 12 months

Showing 4094140960 of 47,632 recalls

Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS AST For the In vitro quantitative determination of AST Recalled by AMS...

The Issue: Marketing the devices outside 510(k) requirements

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· Phillips Respironics, Inc.

Recalled Item: Trilogy Ventilators The Respironics Trilogy 100 system provides continuous...

The Issue: Internal testing revealed a potentially defective component on the power...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 11, 2014· Philips Medical Systems (Cleveland), Inc.

Recalled Item: Pinnacle3 Radiation Therapy Planning (RTP) System Recalled by Philips...

The Issue: Philips Medical Systems have recently determined that a software...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· Synthes, Inc.

Recalled Item: The Synthes Hohmann Retractor Recalled by Synthes, Inc. Due to The Synthes...

The Issue: The Synthes Hohmann Retractor was mis-etched on the product and package as...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS BUN UREA NITROGEN For the In vitro quantitative determination Recalled...

The Issue: Marketing the devices outside 510(k) requirements

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

Class II — Potential Health HazardOngoing
DrugFebruary 11, 2014· Viiv Healthcare Company

Recalled Item: Tivicay (dolutegravir) Tablets 50 mg Recalled by Viiv Healthcare Company Due...

The Issue: Cross Contamination with Other Products: Product contains Promacta...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugFebruary 11, 2014· Teva Pharmaceuticals USA

Recalled Item: QVAR¿ (beclomethasone dipropionate HFA) Recalled by Teva Pharmaceuticals USA...

The Issue: Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugFebruary 11, 2014· Hospira Inc.

Recalled Item: 0.9% Sodium Chloride Injection Recalled by Hospira Inc. Due to Lack of...

The Issue: Lack of Assurance of Sterility:Solution leaking through the port cover of...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugFebruary 11, 2014· Baxter Healthcare Corp.

Recalled Item: Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose Recalled by...

The Issue: Non-Sterility: Complaints of leaks and particulate matter identified as mold...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugFebruary 10, 2014· Hospira Inc.

Recalled Item: Bupivacaine HCl Inj. USP Recalled by Hospira Inc. Due to Presence of...

The Issue: Presence of Particulate Matter: Confirmed customer report of visible...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugFebruary 10, 2014· Actavis Elizabeth LLC

Recalled Item: Alprazolam 1 mg Tablets Recalled by Actavis Elizabeth LLC Due to Failed...

The Issue: Failed Tablet/Capsule Specifications: Complaints were received for...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugFebruary 10, 2014· Pinnacle Biologics Inc

Recalled Item: Photofrin (porfimer sodium) for Injection Recalled by Pinnacle Biologics Inc...

The Issue: Stability Data Does Not Support Expiry: Printed expiration date should be...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
Medical DeviceFebruary 10, 2014· Heraeus Kulzer, LLC.

Recalled Item: BencoDental tartar & stain remover ultrasonic cleaning solution Product...

The Issue: As the result of a complaint to Heraeus Kulzer's customer service...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 10, 2014· Thermedx LLC

Recalled Item: The Thermedx Fluid Management System is designed to provide irrigation...

The Issue: A vendor changed the manufacturing process of a component used in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Siemens Medical Solutions USA, Inc

Recalled Item: AXIOM Artis Systems Product usage: Artis zee is a family Recalled by Siemens...

The Issue: Certain units of the AXIOM Artis Systems are using a flat detector cooling...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Baxter Healthcare Corp.

Recalled Item: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product...

The Issue: Baxter Healthcare Corporation has issued an Urgent Device Correction for the...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The Recalled...

The Issue: Potential safety issue related to unintended radial detector motion, which...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For...

The Issue: Potential safety issue related to unintended radial detector motion, which...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Draeger Medical Systems, Inc.

Recalled Item: Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Recalled by...

The Issue: The battery capacity of the optional PS500 Power Supply Unit of the Infinity...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: Elscint APEX Helix Recalled by GE Healthcare, LLC Due to Potential safety...

The Issue: Potential safety issue related to unintended radial detector motion, which...

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

Class II — Potential Health HazardOngoing