The Recall Desk

State

South Dakota product recalls

73,118 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 73,118 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

13301–13325 of 75802

  • HighFDA (Drugs)·D-0221-2024·2024-01-17

    FDA Recalls Desloratadine Tablets Due to Manufacturing Defect

    Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.

    Product
    DESLORATADINE — DESLORATADINE (DESLORATADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2024·2024-01-17

    ARCHITECT c4000 Processing Module recalled for unlabeled latex component

    Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.

    Product
    ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0649-2024·2024-01-17

    Abiomed Introducer Kit recalled due to sterile barrier compromise risk

    Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.

    Product
    Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0223-2024·2024-01-17

    Tizanidine 4mg Tablets Recalled for Contamination with 2mg Tablets

    Dr. Reddy's Laboratories is recalling Tizanidine 4mg tablets due to the presence of 2mg tablets in bottles. About 38,952 bottles were distributed nationwide.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2024·2024-01-17

    Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect

    Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.

    Product
    Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2024·2024-01-17

    Olympus Updates Manual Cleaning Instructions for Cysto-Nephro Videoscope

    Olympus has updated cleaning instructions for the Model CYF-VH Cysto-Nephro Videoscope. Reusable cleaning brushes are no longer recommended for manual cleaning; single-use brushes remain compatible.

    Product
    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2024·2024-01-17

    Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates

    Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.

    Product
    Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2024·2024-01-17

    Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance

    Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.

    Product
    BrightView X, Gamma Camera, Product Code 882478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2024·2024-01-17

    Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues

    Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.

    Product
    Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0222-2024·2024-01-17

    FDA recalls Bupropion Hydrochloride tablets for foreign tablet contamination

    Rising Pharma Holdings is recalling 47,976 bottles of Bupropion Hydrochloride 150mg tablets nationwide due to foreign tablets or capsules found in some bottles. Consumers should stop use and contact their pharmacist immediately.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2024·2024-01-17

    Abbott Alinity i Processing Module Recalled for Unlabeled Latex Subcomponent

    Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.

    Product
    Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology.…
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0647-2024·2024-01-17

    Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise

    Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.

    Product
    Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2024·2024-01-17

    Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent

    Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.

    Product
    Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The…
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0669-2024·2024-01-17

    Vascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information

    Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.

    Product
    Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2024·2024-01-17

    Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure

    Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.

    Product
    Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2024·2024-01-17

    Townsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk

    Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.

    Product
    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0653-2024·2024-01-17

    Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier

    Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.

    Product
    Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0651-2024·2024-01-17

    Abiomed Introducer Kit Recalled for Compromised Sterile Barrier

    Abiomed is recalling introducer kits due to holes in the outer pouch that compromise the sterile barrier. Non-sterile product could allow microbial contamination, leading to infection such as bacteremia or sepsis.

    Product
    Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2024·2024-01-17

    Olympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations

    Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.

    Product
    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2024·2024-01-17

    Gamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard

    Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.

    Product
    BrightView XCT, Gamma Camera, Product Code 882482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2024·2024-01-17

    Abiomed Oscor Introducer Kit sterile barrier holes risk infection

    Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.

    Product
    Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0219-2024·2024-01-17

    Prescription Tacrolimus Capsules Recalled for Wrong-Strength Product Mix

    Dr. Reddy's Laboratories is recalling 8,280 bottles of Tacrolimus 1 mg capsules after a 0.5 mg capsule was found in a bottle. The wrong-strength capsule could cause dosage confusion.

    Product
    TACROLIMUS — TACROLIMUS (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0671-2024·2024-01-17

    SPRYSTEP VECTOR Ankle-Foot Orthosis Recalled for Structural Failure Risk

    Townsend Design is recalling the SPRYSTEP VECTOR custom ankle-foot orthosis due to potential air pockets between material layers that could cause complete structural failure. Users should stop using the device and contact the manufacturer.

    Product
    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0694-2024·2024-01-17

    SoClean 3 CPAP Cleaner Recalled Over Ozone Exposure Risk

    SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.

    Product
    SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2024·2024-01-17

    Abiomed Introducer Kit Sterile Barrier Compromise Risks Infection

    Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.

    Product
    Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
    Category
    Medical Device
    Distribution
    Distributed nationwide