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. 2,534 recalls have been distributed to South Dakota in the last 12 months.

47,632 total recalls
2,534 in last 12 months

Showing 53215340 of 47,632 recalls

Medical DeviceMay 22, 2024· Thoratec Switzerland GMBH

Recalled Item: 2nd Generation CentriMag Primary Console Recalled by Thoratec Switzerland...

The Issue: Due to a component change, the console part of a circulatory support system...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 22, 2024· Merit Medical Systems, Inc.

Recalled Item: Prelude Roadster Guide Sheath -PG4F90S -PG5F45MP -PG5F45R -PG5F45S Recalled...

The Issue: Due to older version of Instruction for Use (IFU) instructing to ensure that...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 21, 2024· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Chemistry Products FS Diluent Pack 3 Recalled by Ortho-Clinical...

The Issue: VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 21, 2024· CareFusion 303, Inc.

Recalled Item: BD Alaris System Manager Recalled by CareFusion 303, Inc. Due to Due to a...

The Issue: Due to a software issue the PC unit may not connect to the server which...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 21, 2024· Angiodynamics, Inc.

Recalled Item: IsoLoc Prostate Immobilization Treatment Balloon Device Kit Recalled by...

The Issue: A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is...

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

Class II — Potential Health HazardOngoing
DrugMay 20, 2024· Genentech, Inc.

Recalled Item: Cathflo activase (ALTEPLASE) Recalled by Genentech, Inc. Due to Lack of...

The Issue: Lack of Assurance of Sterility: Deformed stoppers observed during filling...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugMay 20, 2024· Pfizer Inc.

Recalled Item: Labetalol Hydrochloride Injection Recalled by Pfizer Inc. Due to Lack of...

The Issue: Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugMay 20, 2024· Pfizer Inc.

Recalled Item: Buprenorphine Hydrochloride Injection Recalled by Pfizer Inc. Due to Lack of...

The Issue: Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceMay 20, 2024· Silkprousa LLC

Recalled Item: Pink Luminous Breast Recalled by Silkprousa LLC Due to Firm is marketing and...

The Issue: Firm is marketing and distributing the Pink Luminous Breast device without...

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

Class II — Potential Health HazardOngoing
DrugMay 17, 2024· Breckenridge Pharmaceutical, Inc

Recalled Item: Duloxetine Delayed-Release Capsules Recalled by Breckenridge Pharmaceutical,...

The Issue: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugMay 17, 2024· GlaxoSmithKline LLC

Recalled Item: Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension Recalled by...

The Issue: Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
Medical DeviceMay 17, 2024· SEASPINE ORTHOPEDICS CORPORATION

Recalled Item: Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade Recalled...

The Issue: Cranial Caudal Blades manufactured incorrectly could result in fracture...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· SEASPINE ORTHOPEDICS CORPORATION

Recalled Item: Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade Recalled...

The Issue: Cranial Caudal Blades manufactured incorrectly could result in fracture...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· Maquet Cardiovascular, LLC

Recalled Item: The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System Recalled by...

The Issue: Potential for there to be a fluid ingress into the handle of the harvesting...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· Siemens Healthcare Diagnostics Inc

Recalled Item: Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Recalled by...

The Issue: Siemens Healthineers has identified an issue with the RAPIDPoint500e system...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· Biomet, Inc.

Recalled Item: RingLoc Bi-Polar Hip System Acetabular Cup Recalled by Biomet, Inc. Due to...

The Issue: 41 mm acetabular outer heads were potentially assembled with a 42 mm locking...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· Maquet Cardiovascular, LLC

Recalled Item: The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for...

The Issue: Potential for there to be a fluid ingress into the handle of the harvesting...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· B Braun Medical Inc

Recalled Item: Stimuplex A Recalled by B Braun Medical Inc Due to The devices are labeled...

The Issue: The devices are labeled "not made with DEHP" or the DEHP free symbol;...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· B Braun Medical Inc

Recalled Item: Stimuplex A Recalled by B Braun Medical Inc Due to The devices are labeled...

The Issue: The devices are labeled "not made with DEHP" or the DEHP free symbol;...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2024· B Braun Medical Inc

Recalled Item: Stimuplex A Recalled by B Braun Medical Inc Due to The devices are labeled...

The Issue: The devices are labeled "not made with DEHP" or the DEHP free symbol;...

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

Class II — Potential Health HazardOngoing