The Recall Desk

State

South Dakota product recalls

73,106 recalls have nationwide distribution and so reach South Dakota. 2,684 additional recalls listed South Dakota specifically in their distribution scope.

What the numbers show

Total
2,684
Critical
401
Severe
567
Most recent
2026-09-23

Of the 2,684 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 567 (21%) are Severe.

These figures cover only the 2,684 recalls whose distribution notice names South Dakota specifically. The 73,106 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

12826–12850 of 75790

  • HighFDA (Devices)·Z-1020-2024·2024-02-14

    Cefotaxime antibiotic susceptibility test discs recalled for potential testing accuracy failures

    BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.

    Product
    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2024·2024-02-14

    Flow-e Anesthesia System Model 6887900 Cybersecurity Vulnerability Recall

    The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.

    Product
    Flow-e Anesthesia System, model 6887900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2024·2024-02-14

    BD antibiotic susceptibility test discs recalled for possible accuracy failures

    BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2024·2024-02-14

    Senographe Pristina X-ray system missing audible exposure termination signal

    GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.

    Product
    Senographe Pristina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2024·2024-02-14

    Medical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect

    Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.

    Product
    Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2024·2024-02-14

    Globus Medical Cannula May Not Be Properly Sterilized

    Some ExcelsiusGPS Cannulas have an internal gap that prevents proper sterilization, increasing infection risk. Globus Medical is recalling 570 units distributed worldwide.

    Product
    ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2024·2024-02-14

    BD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures

    BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.

    Product
    BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2024·2024-02-14

    BD Sensi Disc Cefepime antibiotic susceptibility testing accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Cefepime antibiotic testing discs due to accuracy and reproducibility failures. These laboratory products may produce inaccurate test results, potentially leading to delayed diagnoses or inappropriate antibiotic treatment.

    Product
    BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2024·2024-02-14

    Globus Medical Cranial Drills recalled for sterility loss and discoloration

    Globus Medical is recalling Cranial Drills (2.40mm) due to packaging breaches that may compromise sterility and discoloration near the drill tip. Distributed worldwide.

    Product
    Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2024·2024-02-14

    BD BBL Antibiotic Susceptibility Test Discs Recalled for Accuracy Failures

    BD BBL Ceftazidime Sensi Discs used for antibiotic susceptibility testing may have accuracy failures affecting H. influenzae testing. This could lead to delayed diagnoses or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2024·2024-02-14

    BD BBL Sensi Disc Imipenem susceptibility test accuracy and quality failures

    BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2024·2024-02-14

    Optima Coil Neurovascular Embolization Devices Risk Foreign Emboli From Corrosion

    BALT's Optima Coil neurovascular embolization devices may have corroded solder flux residue on the delivery pusher that could break off and cause foreign emboli in patient blood vessels.

    Product
    Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1003-2024·2024-02-14

    Siemens Atellica CH Immunoglobulin M Reagent Quality Control Bias

    Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.

    Product
    Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2024·2024-02-14

    Steris Dual Articulating Headrest May Fail to Lock During Procedures

    A Steris medical headrest may fail to lock during patient procedures, potentially causing injury or procedural delays. Affected units were manufactured between August and October 2023.

    Product
    Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2024·2024-02-14

    Philips Spectral CT software issue causes image mislabeling

    A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.

    Product
    Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2024·2024-02-14

    Dental amalgam powder may not triturate properly, affecting restoration strength

    Ivoclar Vivadent is recalling dental amalgam powder that may not triturate properly, affecting restoration strength and working characteristics. Dentists should stop using the recalled lot and contact the manufacturer.

    Product
    Article No. NA6050411, Valiant PhD No. 1 Econo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2024·2024-02-14

    Patient transportation system wheels may be attracted to MRI magnetic fields

    Ingenia Ambition X patient transportation system trolleys contain magnetic wheels that may be attracted to MRI magnetic fields, potentially causing trolley malfunction during patient procedures.

    Product
    Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2024·2024-02-14

    Anesthesia System Cybersecurity Vulnerability Poses Denial of Service Risk

    The Flow-i C30 Anesthesia System contains a cybersecurity vulnerability allowing remote attackers to cause denial of service, tampering, or code execution, potentially creating hazardous conditions.

    Product
    Flow-i C30 Anesthesia System, model 6677300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2024·2024-02-14

    Philips Spectral CT 7500 software issue causes incorrect image labeling

    Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.

    Product
    Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2024·2024-02-14

    Surgical hip instruments recalled due to compromised sterility packaging

    Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2024·2024-02-14

    Medical Device Recall: BD BBL Cefaclor Antibiotic Susceptibility Test Disc

    Becton Dickinson is recalling BD BBL Sensi Disc Cefaclor antibiotic susceptibility test discs due to possible accuracy and quality control failures. Affected discs may produce inaccurate results, risking delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2024·2024-02-14

    BD BBL Sensi Disc Cefixime Antibiotic Susceptibility Test Accuracy Failures

    BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.

    Product
    BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2024·2024-02-14

    Hip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure

    Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2024·2024-02-14

    Globus Medical Cranial Drill recalled for potential sterility compromise

    Globus Medical is recalling Cranial Drills due to potential sterility loss from packaging breaches and discoloration at the drill tip. The drills are used in cranial surgery with the ExcelsiusGPS system.

    Product
    Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2024·2024-02-14

    BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis

    Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
    Category
    Medical Device
    Distribution
    Distributed nationwide