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. 2,396 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,396 in last 12 months

Showing 2048120500 of 27,558 recalls

Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 4600 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Therakos Inc

Recalled Item: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog...

The Issue: The Mallinckrodt (Therakos) post-market monitoring process detected an...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· ConMed Corporation

Recalled Item: Hip Preservation System Signature Series PreBent Burs under the following...

The Issue: Metal shavings released from burs during use are due to contact between the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 250 Chemistry Systems Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Arjo, Inc. dba ArjoHuntleigh

Recalled Item: The Concerto Basic Shower Trolley is intended for assisted hygiene care...

The Issue: Reports of the bolts connecting the stretcher to the hydraulic piston and...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Baxter Corporation Englewood

Recalled Item: Baxter Recalled by Baxter Corporation Englewood Due to All lots of RAPIDFILL...

The Issue: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 5 Recalled by Ortho-Clinical Diagnostics Due to Increased U90-382 or...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 350 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Northeast Laboratory Services, Inc.

Recalled Item: NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.:...

The Issue: Product marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Stryker Spine

Recalled Item: Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine...

The Issue: Reported jamming of the impaction handle when assembled to the Inserter...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· EndoChoice, Inc.

Recalled Item: Fuse 1C Colonoscope Recalled by EndoChoice, Inc. Due to The bending section...

The Issue: The bending section of the device may partially separate from the insertion...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· NeoCoil, LLC

Recalled Item: NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil Recalled by NeoCoil, LLC...

The Issue: Potential for higher than specified surface temperatures. Use of 3.0T GEM...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter Recalled by C.R....

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter Recalled by C.R. Bard,...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Elekta, Inc.

Recalled Item: Oncentra External Beam - VMAT - Radiation therapy planning system Recalled...

The Issue: When using the option "Tumor Overlap Fraction" in VMAT planning it has been...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· GE Medical Systems, LLC

Recalled Item: Mavig Monitor Suspension System Recalled by GE Medical Systems, LLC Due to...

The Issue: GE Healthcare has recently become aware of a reported incident in which a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView are gamma cameras Recalled by Philips Medical Systems (Cleveland)...

The Issue: The firm discovered four issues with the BrightView Family systems. Issue 1:...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Arthrex, Inc.

Recalled Item: Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC Recalled by...

The Issue: Devices reported to have a smooth texture to the outer surface of the metal,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Merge Healthcare, Inc.

Recalled Item: RadSuite Recalled by Merge Healthcare, Inc. Due to Potential incorrect...

The Issue: Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.

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

Class II — Potential Health HazardOngoing