State

South Dakota product recalls

73,478 recalls have nationwide distribution and so reach South Dakota. 2,686 additional recalls listed South Dakota specifically in their distribution scope.

What the numbers show

Total: 2,686
Critical: 401
Severe: 747
Most recent: 2026-10-14

Of the 2,686 recalls naming South Dakota we have scored against our rubric, 401 (15%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 747 (28%) are Severe.

Which agencies issued them

These figures cover only the 2,686 recalls whose distribution notice names South Dakota specifically. The 73,478 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

22776–22800 of 76164

SevereFDA (Devices)·Z-0451-2022·2022-01-26
Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage
Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.
Product
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V034000·2022-01-26
Audi vehicles recalled for rear axle misalignment causing premature tire wear
Certain 2019-2021 Audi vehicles are recalled for rear axle misalignment that may cause premature tire wear and increase crash risk. Dealers will inspect and adjust the alignment at no charge, replacing any worn tires as needed.
Product
AUDI — AUDI S5, A4 ALLROAD, S7, Q5
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0501-2022·2022-01-26
Draeger Fabius MRI Anesthesia Machines recalled due to misrouted oxygen hoses
Draeger Medical recalls 26 Fabius MRI Anesthesia Machines due to incorrectly routed internal oxygen hoses. The misrouting can cause oxygen flow to deviate from set levels, risking inadequate patient oxygenation.
Product
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V033000·2022-01-26
2021 Toyota Venza Hybrid rear turn signal lighting system failure recall
Toyota is recalling certain 2021 Venza Hybrid vehicles due to water intrusion in rear turn signal lights, which can cause electrical short circuits and lighting failure, increasing crash risk.
Product
TOYOTA — TOYOTA VENZA HYBRID
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2022·2022-01-26
Dental implant kits recalled for mislabeled implant dimensions
Straumann USA LLC is recalling certain Neodent Easypack dental implant kits due to mislabeling where packaging does not match the implant dimensions inside. Affected units contain 3.5x8mm implants instead of the labeled 3.5x13mm size.
Product
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·22058·2022-01-26
Eguana Technologies Evolve Home Energy Storage Systems Recalled for Fire Hazard
Eguana Technologies is recalling about 245 Evolve Home Energy Storage Systems because the lithium-ion battery modules can overheat and pose a fire hazard. Consumers should contact the company immediately to schedule a free repair or battery replacement.
Product
Evolve Home Energy Storage Systems
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·22060·2022-01-26
Geri-Care Over-the-Counter Drugs Recalled for Non-Child-Resistant Packaging
Geri-Care Pharmaceuticals is recalling about 800 bottles of over-the-counter acetaminophen and aspirin tablets because the packaging is not child resistant, posing a poisoning risk to young children.
Product
Over-the-counter drugs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2022·2022-01-26
Gentueri Viral Transport Medium Recalled Due to Turbidity and Discoloration
Gentueri Inc is recalling 4,150 units of Gentueri Viral Transport Medium (VTM) nationwide due to visual turbidity and discoloration that may compromise diagnostic samples in transit.
Product
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2022·2022-01-26
VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results
Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0500-2022·2022-01-26
ImagePilot diagnostic imaging software versions 1.92 and 1.93 measurement error recall
Konica Minolta's ImagePilot versions 1.92 and 1.93 software may provide incorrect measurement calculations if improper power sequences are used with AeroDR or Momentum Panel systems.
Product
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2022·2022-01-26
Voyager Rollator Walkers Recalled for Wheel Separation and Fall Risk
Compass Health Brands is recalling 3,734 Voyager Rollator walkers due to cracking wheel spokes that may cause wheels to separate from the axle, potentially resulting in patient falls and injuries.
Product
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0511-2022·2022-01-26
Microbiological Reference Products Recalled for Bacterial Contamination
Microbiologics Inc is recalling KWIK-STIK and LYFO DISK microbiological reference products contaminated with Staphylococcus epidermidis. Fifty-nine kits were distributed to multiple U.S. states and countries.
Product
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0512-2022·2022-01-26
Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.
Product
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·22057·2022-01-26
Children's Nightgowns Recalled for Flammability Standard Violation
AOSKERA is recalling approximately 1,000 children's nightgowns sold on Amazon.com from October 2020 through May 2021 because they fail to meet federal flammability standards for children's sleepwear, posing a burn injury risk.
Product
Children's Nightgowns
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0497-2022·2022-01-26
Senior Living Nurse Call Systems Failing to Alarm Due to Memory Issue
Stanley Security Solutions is recalling 11 Senior Living Arial Emergency and Nurse Call Systems because they fail to alarm due to increased memory consumption, potentially preventing nursing staff from responding to resident emergencies.
Product
Senior Living Arial Emergency and Nurse Call Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0499-2022·2022-01-26
FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error
Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.
Product
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0508-2022·2022-01-26
Cardinal Infant Heel Warmer recalled due to unapproved labeling changes
Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.
Product
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2022·2022-01-26
Medical Device Mattress Recalled for Labeling Non-Compliance with FDA Requirements
Philips is recalling 141,750 Infa-Therm Transport Mattresses because modified labeling does not comply with FDA clearance requirements. The devices cannot be distributed or sold without new FDA clearance.
Product
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0381-2022·2022-01-26
Fexofenadine/Pseudoephedrine tablets recalled for failed dissolution
Dr. Reddy's Laboratories is recalling Kroger Allergy Relief-D tablets (fexofenadine HCl 60mg/pseudoephedrine HCl 120mg) due to failed dissolution specifications. Approximately 11,064 boxes distributed nationwide are affected.
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0498-2022·2022-01-26
Medical Device Assay Kits Recalled for Potential Instrument Leakage
Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.
Product
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0506-2022·2022-01-26
Infant Heel Warmers Recalled for Unauthorized Labeling Changes
Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.
Product
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0391-2022·2022-01-26
Extra Strength Headache tablets recalled for CGMP manufacturing deviations
Medique Products is recalling Extra Strength Headache tablets nationwide after an FDA inspection found they were not manufactured under Current Good Manufacturing Practices.
Product
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0386-2022·2022-01-26
Leader 12HR Allergy & Congestion Relief tablets fail dissolution test
Dr. Reddy's Laboratories is recalling Leader brand 12HR Allergy & Congestion Relief tablets due to failed dissolution specifications. The product may not release its active ingredients properly.
Product
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0373-2022·2022-01-26
Brinzolamide Ophthalmic Suspension recalled for defective container caps
Teva Pharmaceuticals is recalling Brinzolamide Ophthalmic Suspension 1% due to defective container caps. The notch in the dropper cap could break off and block dispensing of the medication.
Product
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0374-2022·2022-01-26
Clobetasol Propionate Foam Recalled for CGMP Deviations
Ingenus Pharmaceuticals is recalling 45,173 cans of Clobetasol Propionate Foam, 0.05%, nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, FDA Class II recall.
Product
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Category
Drug
Distribution
Distributed nationwide