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. 2,365 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,365 in last 12 months

Showing 2458124600 of 27,558 recalls

Medical DeviceOctober 9, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is...

The Issue: A labeling correction was initiated related to the Surgical Technique Guide...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2013· Ortho-Clinical Diagnostics

Recalled Item: enGen Track System with enGen Select v5.0 with autoverification enabled...

The Issue: Ortho Clinical Diagnostics issued an Urgent Product Correction Notification...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder...

The Issue: Complaints were received which described the SynFix LR implant holder...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2013· Ortho-Clinical Diagnostics

Recalled Item: enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5...

The Issue: Ortho Clinical Diagnostics issued an Urgent Product Correction Notification...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II Recalled by Smith & Nephew Inc Due to Swapped product....

The Issue: Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2013· Medtronic Vascular, Inc.

Recalled Item: Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm...

The Issue: A small number of units in lot number 0006573585 of the Resolute Integrity...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2013· Mindray DS USA, Inc. dba Mindray North America

Recalled Item: Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)...

The Issue: Mindray has identified an issue with V Series Monitor where the V Dock power...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2013· RTI Surgical, Inc.

Recalled Item: C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " Recalled by...

The Issue: As the result of a recent internal review of regulatory documents, we have...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II Recalled by Smith & Nephew Inc Due to Swapped product....

The Issue: Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2013· Siemens Healthcare Diagnostics, Inc.

Recalled Item: User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension...

The Issue: When utilizing the Routine Inventory screen to enter a User Defined Method...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 7, 2013· Baxter Healthcare Corp.

Recalled Item: 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on...

The Issue: In systems with version 10.4 software Initial Drain logic, the device will...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 4, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products COCM Reagent Recalled by Ortho-Clinical...

The Issue: Inaccurate quality control results.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 3, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual Recalled...

The Issue: Complaints were received for intraoperative reamer head breakages which can...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 3, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes...

The Issue: A potential exists for non conforming Synthes Titanium Trochanteric Fixation...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 3, 2013· Advanced Sterilization Products

Recalled Item: STERITITE Containers: STERITITE Container Kit Recalled by Advanced...

The Issue: Advanced Sterilization Products (ASP) is recalling the SteriTite containers...

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

Class III — Low RiskOngoing
Medical DeviceOctober 3, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to...

The Issue: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Beckman Coulter Inc.

Recalled Item: Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System...

The Issue: Beckman Coulter is initiating a recall for the Access Immunoassay Systems...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Nipro Diagnostics, Inc.

Recalled Item: MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for...

The Issue: Manufactured with an incorrect factory set unit of measure.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Intuitive Surgical, Inc.

Recalled Item: Single Site Bipolar Maryland Forceps Intuitive Surgical Recalled by...

The Issue: A limited number of FDA-cleared instruments for da Vinci Single Site use,...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Intuitive Surgical, Inc.

Recalled Item: Single Site Curved Needed Driver Intuitive Surgical Recalled by Intuitive...

The Issue: A limited number of FDA-cleared instruments for da Vinci Single Site use,...

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

Class II — Potential Health HazardOngoing