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 2090120920 of 27,558 recalls

Medical DeviceOctober 28, 2015· BC Group International Inc

Recalled Item: DA-2006P - Defibrillator / Pacer Analyzer Recalled by BC Group International...

The Issue: Device is not functioning as intended: Two wires running to the ECG...

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

Class III — Low RiskOngoing
Medical DeviceOctober 28, 2015· Quest Medical, Inc.

Recalled Item: Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes...

The Issue: The products have been found to intermittently exhibit a seal failure during...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· Baylis Medical Corp *

Recalled Item: ProTrack Microcatheter. Model/Catalog Numbers CIC38-145 Recalled by Baylis...

The Issue: Microcatheter may have circumferential defects (cracks) along its shaft.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· Medtronic Perfusion Systems

Recalled Item: Medtronic Perfusion Tubing Packs Recalled by Medtronic Perfusion Systems Due...

The Issue: This recall is being initiated due to a potential breach of the Tubing Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2015· Implant Direct Sybron Manufacturing, LLC

Recalled Item: DGDE Recalled by Implant Direct Sybron Manufacturing, LLC Due to Implant...

The Issue: Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2015· Carl Zeiss Meditec AG

Recalled Item: IOL Master 5.5: Software versions 7.5 and 7.7 Recalled by Carl Zeiss Meditec...

The Issue: IOL Master software versions 7.5 and 7.7 calculation printouts and exported...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2015· Carl Zeiss Meditec AG

Recalled Item: IOL Master 500: Software versions 7.5 and 7.7 Recalled by Carl Zeiss Meditec...

The Issue: IOL Master software versions 7.5 and 7.7 calculation printouts and exported...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2015· Merz North America, Inc.

Recalled Item: PROLARYN Injectable Implant 1.0 cc Gel Recalled by Merz North America, Inc....

The Issue: The expiration date encoded in the UDI barcode on the label on the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2015· Merz North America, Inc.

Recalled Item: PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA)...

The Issue: The expiration date encoded in the UDI barcode on the label on the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2015· Merz North America, Inc.

Recalled Item: Radiesse (+) Lidocaine Injectable Implant 1.5cc Recalled by Merz North...

The Issue: The expiration date encoded in the UDI barcode on the label on the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2015· ArthroCare Corporation

Recalled Item: Cavity 8 Gauge Spine Wand indicated for resection Recalled by ArthroCare...

The Issue: There is cracking in the tray when the device is snapped into place. The...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2015· GE Medical Systems, LLC

Recalled Item: GE Healthcare Recalled by GE Medical Systems, LLC Due to GE Healthcare has...

The Issue: GE Healthcare has recently become aware of a potential issue with routine...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2015· Fresenius Medical Care Renal Therapies Group, LLC

Recalled Item: Fresenius 132 Gallon Dry Acid Dissolution Unit Recalled by Fresenius Medical...

The Issue: Dissolution units and replacement motors units do not provide full thermal...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2015· Fresenius Medical Care Renal Therapies Group, LLC

Recalled Item: Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units) Recalled...

The Issue: Dissolution units and replacement motors units do not provide full thermal...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2015· Fresenius Medical Care Renal Therapies Group, LLC

Recalled Item: Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For...

The Issue: Dissolution units and replacement motors units do not provide full thermal...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2015· Otto Bock Healthcare GmbH

Recalled Item: iOS Galileo Application Version 1.1.1 or lower that programs the Recalled by...

The Issue: A software issue can make the foot move into dorsiflexion, unnoticed by the...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2015· Medtronic Vascular, Inc.

Recalled Item: Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152...

The Issue: Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 22, 2015· Mercury Enterprises, Inc. dba Mercury Medical

Recalled Item: Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The...

The Issue: Incorrect use of T-Piece resuscitators will result in complete occlusion of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 22, 2015· Innokas Medical Oy

Recalled Item: CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans Recalled...

The Issue: Monitor may shut down unintentionally without restarting.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 21, 2015· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 4F Recalled by LeMaitre...

The Issue: Manufacturing issue that could cause a pinhole in the formed end of the...

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

Class II — Potential Health HazardOngoing