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. 2,452 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,452 in last 12 months

Showing 1666116680 of 27,558 recalls

Medical DeviceSeptember 15, 2017· Encore Medical, Lp

Recalled Item: EMPOWR PS KNEE(TM) e+ Recalled by Encore Medical, Lp Due to It was reported...

The Issue: It was reported that an implant labeled as 343-13-708 was packaged with...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2017· Encore Medical, Lp

Recalled Item: EMPOWR PS KNEE(TM) e+ Recalled by Encore Medical, Lp Due to It was reported...

The Issue: It was reported that an implant labeled as 343-13-708 was packaged with...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2017· C.R. Bard, Inc.

Recalled Item: Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box Recalled by...

The Issue: Several instances of a catheter caught in the sterile barrier seal and in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2017· C.R. Bard, Inc.

Recalled Item: HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box...

The Issue: Several instances of a catheter caught in the sterile barrier seal and in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2017· C.R. Bard, Inc.

Recalled Item: Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box...

The Issue: Several instances of a catheter caught in the sterile barrier seal and in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2017· Zimmer Biomet, Inc.

Recalled Item: Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa Recalled by...

The Issue: Fracture of the bolt connecting the insertion guide to the intramedullary...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2017· Zimmer Biomet, Inc.

Recalled Item: 14-442000S Antegrade Femoral Nail Instrument Kit Recalled by Zimmer Biomet,...

The Issue: Fracture of the bolt connecting the insertion guide to the intramedullary...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2017· Zimmer Biomet, Inc.

Recalled Item: 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument....

The Issue: Fracture of the bolt connecting the insertion guide to the intramedullary...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· St. Jude Medical, Inc.

Recalled Item: Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse...

The Issue: Analysis of the difference between the actual device longevity and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· Abbott Point Of Care Inc.

Recalled Item: i-STAT DE handheld data processing module for clinical use Recalled by...

The Issue: Issues resulting from upgrade to software version 2.8: (1) Location,...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· Toshiba American Medical Systems Inc

Recalled Item: Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is...

The Issue: During an examination images were displayed on the live monitor,but the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· Zoll Manufacturing Corp.

Recalled Item: LifeVest Wearable Defibrillator Model 4000 Recalled by Zoll Manufacturing...

The Issue: Incorrect service code for properly catching critical defects during...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· St. Jude Medical, Inc.

Recalled Item: Proclaim DRG Implantable Pulse Generator Model 3664 Recalled by St. Jude...

The Issue: Analysis of the difference between the actual device longevity and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· St. Jude Medical, Inc.

Recalled Item: Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Recalled...

The Issue: Analysis of the difference between the actual device longevity and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 8, 2017· Sysmex America, Inc.

Recalled Item: Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets Recalled...

The Issue: There is potential that fluorescent platelet (PLT-F) and immature platelet...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2017· Radiometer America Inc

Recalled Item: AutoCheck5+ Recalled by Radiometer America Inc Due to Radiometer has...

The Issue: Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 5, 2017· Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Recalled Item: Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ Recalled by Medex...

The Issue: Lack of sterility assurance: leaking containers which could lead to exposure...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 5, 2017· Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Recalled Item: Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿...

The Issue: Lack of sterility assurance: leaking containers which could lead to exposure...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 5, 2017· Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Recalled Item: Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ Recalled by Medex...

The Issue: Lack of sterility assurance: leaking containers which could lead to exposure...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 5, 2017· Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Recalled Item: Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ Recalled by Medex...

The Issue: Lack of sterility assurance: leaking containers which could lead to exposure...

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

Class I — Serious Health HazardOngoing