State

South Dakota product recalls

73,509 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 73,509 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

24176–24200 of 76195

HighFDA (Devices)·Z-2460-2021·2021-09-22
BD needle-free connector valves recalled for flow obstruction risk
BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.
Product
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2443-2021·2021-09-22
Hero Model 100 Smart Pill Dispenser Recalled for Software Dose-Prompting Error
Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.
Product
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2476-2021·2021-09-22
Philips Azurion Imaging System Failure at 480V Hospital Power Supply
Philips Azurion medical imaging devices may fail when powered by hospital electrical systems providing 480V. The failure reduces X-ray performance and may be preceded by a burning smell.
Product
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2470-2021·2021-09-22
Arjo Disposable Repositioning Sling Recalled for Trip Hazard Risk
Getinge recalled 46,085 Arjo Disposable Repositioning Sling units because the sling loop straps pose a trip hazard. The affected devices were distributed nationwide to healthcare facilities.
Product
Arjo Disposable Repositioning Sling, Model AHD001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2446-2021·2021-09-22
Siemens radiation therapy software may lose treatment structure data
Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.
Product
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2449-2021·2021-09-22
Pentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions
Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.
Product
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2466-2021·2021-09-22
BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues
BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.
Product
BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2453-2021·2021-09-22
Configura Advance Mobility Chairs Recalled for Potential Backrest Detachment
Accora Inc is recalling multiple Configura Advance Chair models due to a potential defect where the backrest may detach, creating a fall risk for users.
Product
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0794-2021·2021-09-22
Oxycodone Hydrochloride Tablets Recalled for Foreign Tablet Contamination
Rhodes Pharmaceuticals is recalling Oxycodone Hydrochloride 10 mg tablets (Lot # WP5K0Y) distributed nationwide after a foreign Hydrochlorothiazide/Lisinopril tablet was found in one bottle.
Product
OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2447-2021·2021-09-22
MR MAGNETOM Imaging Systems Risk Data Loss in Treatment Planning
Siemens MR MAGNETOM imaging systems may lose treatment planning data when editing structure sets after reopening a saved study, resulting in incomplete treatment plans being transmitted to planning systems.
Product
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2464-2021·2021-09-22
Needle-Free Burette Set Valves Recalled for Occlusion and Flow Issues
BD ADD-ON Burette Set V/NV Needle-Free Valves may experience occlusions or flow issues that could delay therapy. CAREFUSION recalled 44,120 units with this defect.
Product
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2459-2021·2021-09-22
BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues
BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.
Product
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2448-2021·2021-09-22
Pentax Medical Colonoscopes and Upper GI Scopes Updated Reprocessing Instructions
Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.
Product
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2477-2021·2021-09-22
Lyra Direct SARS-CoV-2 Assay Instructions Revised for False Negative Risk
The Lyra Direct SARS-CoV-2 assay can produce false negatives on certain PCR machines when specimens have high viral loads. Revised instructions address this diagnostic failure risk affecting approximately 81,910 kits distributed worldwide.
Product
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2452-2021·2021-09-22
Cellex COVID-19 Antigen Test kits recalled for lacking FDA emergency use authorization
Cellex is recalling approximately 44,821 units of its qSARS-CoV-2 Antigen Rapid Test due to lack of FDA emergency use authorization. The test was distributed nationwide in California, Florida, Texas, and Wisconsin.
Product
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2454-2021·2021-09-22
Extension Set SMALLBORE Tubing with SmartSite Valves Recalled for Flushing Issues
BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.
Product
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2462-2021·2021-09-22
BD Gravity Burette Set Needle-Free Connector Valves Recalled for Flow Issues
CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.
Product
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2463-2021·2021-09-22
BD Gravity IV needle-free connector valve occlusion risk
BD Gravity IV needle-free connector valves may develop flow issues and partial or total occlusions that could delay therapy. The recall affects 24,360 units distributed worldwide.
Product
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES &…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2445-2021·2021-09-22
Radiation Therapy Software Risk: Data Loss in Treatment Planning
Siemens radiation therapy planning software may lose data when editing treatment structures. Incomplete structure sets could be sent to the treatment planning system, affecting treatment plan accuracy.
Product
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2471-2021·2021-09-22
Siemens ACUSON Juniper ultrasound system recalled for intermittent power supply failure
Siemens Medical Solutions USA is recalling 15 ACUSON Juniper Diagnostic Ultrasound Systems worldwide due to intermittent power supply failures that render the devices inoperable. No injuries or illnesses have been reported.
Product
ACUSON Juniper Diagnostic Ultrasound System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2474-2021·2021-09-22
Philips Allura Xper X-ray imaging system failures at 480V power supply
Four Philips Allura Xper X-ray imaging systems may fail prematurely when powered at 480V hospital mains, causing coil overheating and reduced imaging performance.
Product
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2468-2021·2021-09-22
BD Needle-Free Bag Access Valves Recalled for Flow Obstruction
BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.
Product
BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2475-2021·2021-09-22
Philips Allura Xper Imaging System Overheating and Malfunction Recall
Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.
Product
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2451-2021·2021-09-22
FDA Recalls Luminex Verigene Enteric Pathogen Test Kits for False Positive Results
Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.
Product
Verigene EP Amplification Reagent Kit Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2458-2021·2021-09-22
BD needle-free connector valves may occlude or restrict fluid flow
BD Burette Gravity Set needle-free connector valves may fail to flush or develop blockages, potentially delaying patient therapy. Lot 21015553 consists of approximately 630 units distributed worldwide.
Product
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
Category
Medical Device
Distribution
Distributed nationwide