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. 2,447 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,447 in last 12 months

Showing 1724117260 of 27,558 recalls

Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS 80mm Curved Rod. Part of MAXIMIS Pedicle Screw Recalled by...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Recalled by...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Recalled by...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Recalled by Valorem...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Rod Checker. Part of MAXIMIS Pedicle Screw Spinal Recalled...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. Part of MAXIMIS Recalled by Valorem...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS 300mm Straight Rod. Part of MAXIMIS Pedicle Screw Recalled...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Marking Pin (Round Jaw). Part of MAXIMIS Pedicle Recalled...

The Issue: Devices are not consistent with Quality System Requirements.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 20, 2017· Beckman Coulter Inc.

Recalled Item: UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Recalled by...

The Issue: The firm has identified that a fitting in some Slidemaker Stainer units may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 20, 2017· Keystone Dental Inc

Recalled Item: Multi-Unit Abutment Angled Recalled by Keystone Dental Inc Due to Abutments...

The Issue: Abutments are unable to accept the final abutment screw

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 19, 2017· Nova Biomedical Corporation

Recalled Item: Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Recalled by...

The Issue: Software- scheduled A-QC analysis could initiate prior to a patient result...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 19, 2017· ConMed Corporation

Recalled Item: STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary Recalled by ConMed...

The Issue: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 19, 2017· ConMed Corporation

Recalled Item: STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets...

The Issue: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 19, 2017· Elekta, Inc.

Recalled Item: iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning...

The Issue: Incorrect PEC values.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 16, 2017· Maquet Datascope Corp - Cardiac Assist Division

Recalled Item: CS 100 Intra-Aortic Balloon Pump Recalled by Maquet Datascope Corp - Cardiac...

The Issue: The device failed to pump due to an electrical test failure code #58 (power...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 16, 2017· Keystone Dental Inc

Recalled Item: Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant...

The Issue: An 8mm diameter bone tap was laser marked as 7mm diameter and was packed...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 16, 2017· Maquet Datascope Corp - Cardiac Assist Division

Recalled Item: CS 300 Intra-Aortic Balloon Pump Recalled by Maquet Datascope Corp - Cardiac...

The Issue: The device failed to pump due to an electrical test failure code #58 (power...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 16, 2017· Maquet Datascope Corp - Cardiac Assist Division

Recalled Item: CS 100i Intra-Aortic Balloon Pump Recalled by Maquet Datascope Corp -...

The Issue: The device failed to pump due to an electrical test failure code #58 (power...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 15, 2017· Steris Corporation

Recalled Item: Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box Recalled by...

The Issue: On June 15, 2017, STERIS identified that the purple ink located on the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 15, 2017· Steris Corporation

Recalled Item: Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box Recalled by...

The Issue: On June 15, 2017, STERIS identified that the purple ink located on the...

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

Class II — Potential Health HazardOngoing