South Dakota recalls
3221 federal recalls on file affecting South Dakota - 145 South Dakota-specific plus 3076 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideSperm Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwidePregnancy Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideParasite Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideOvulation Test (5 tests)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideMycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideMPOX Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideMenopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideLyme Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideIron Deficiency Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideHPV Antigen Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideHerpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideH pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideGonorrhea test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideFemale Fertility Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideFecal Occult Blood Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideEpstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideDrug Test Small (4 substances)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideIllegally Marketed
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideDiabetes HbA1c Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideD-Dimer Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideChlamydia Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideCandida Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideBlood Type Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideAlcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceMedtronicClass IINationwideAurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-12-10FDA-DeviceEnterixClass IINationwideInSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
- 2025-12-10FDA-DeviceFresenius KabiClass INationwideIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- 2025-12-10FDA-FoodGeneproClass IGenepro Whey 4th Generation Plasma Treated Protein, unflavored, Net Wt. 225g, 30 servings, packaged in a resealable mylar bag, UPC 850053365126, Manufactured For: Genepro Protein, Inc. 15000 Weston Parkway, Cary NC 27513 Front label reads, in part: "* LACTOSE FREE * DAIRY FREE *ALLERGEN FREE" Back label reads, in part: "OTHER INGREDIENTS: Hydrolyzed NiHPRO ProteinIsolate (Pea Protein Isolate, Rice Protein Isolate, Mungbean Protein Isolate, L-Lysine, L-Leucine, L-Threonine, L-Methionine). CONT
Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
- 2025-12-10FDA-FoodCostcoClass IICostco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.
- 2025-12-10FDA-FoodCostcoClass IICostco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material.
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