The Recall Desk

State

South Dakota product recalls

72,907 recalls have nationwide distribution and so reach South Dakota. 2,681 additional recalls listed South Dakota specifically in their distribution scope.

What the numbers show

Total
2,681
Critical
401
Severe
565
Most recent
2026-09-02

Of the 2,681 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 565 (21%) are Severe.

These figures cover only the 2,681 recalls whose distribution notice names South Dakota specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

851–875 of 75588

  • SevereFDA (Drugs)·D-0650-2026·2026-07-08

    ChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide. The products were unsterilized and distributed outside the intended channel intended for further processing and sterilization.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2644-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2026·2026-07-08

    CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide

    Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.

    Product
    CRE Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2026·2026-07-08

    DSAEK Pack-RX surgical kits recalled for bacterial contamination

    Windstone Medical Packaging is recalling 1,080 DSAEK Pack-RX surgical convenience kits containing Webcol Large Alcohol Prep Pads contaminated with Paenibacillus phoenicis bacteria discovered during a sterilization audit.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0648-2026·2026-07-08

    ChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance

    CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2610-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing Swan-Ganz catheters are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may lead to infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2624-2026·2026-07-08

    Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk

    Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.

    Product
    Medtronic Harmony Delivery Catheter System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2603-2026·2026-07-08

    Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage

    Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.

    Product
    Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2640-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking Failure Risk

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2672-2026·2026-07-08

    GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall

    W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.

    Product
    GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0647-2026·2026-07-08

    ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization

    CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V437000·2026-07-08

    2026 Toyota Grand Highlander Hybrid rear axle carrier structural defect

    Toyota is recalling certain 2026 Grand Highlander Hybrid and related models because the rear axle carriers may have insufficient material strength and could break, causing loss of vehicle control and increasing crash risk.

    Product
    TOYOTA — TOYOTA, LEXUS GRAND HIGHLANDER, GRAND HIGHLANDER HYBRID, TX, TX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2550-2026·2026-07-08

    Hillrom VOLARA System patient circuits recalled for nebulizer leakage risk

    Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper medication delivery.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2026·2026-07-08

    Revitaderm Wound Care Gel recalled for microbial contamination

    Revitaderm Wound Care Gel has been recalled due to microbial contamination with Lysinibacillus fusiformis and other Bacillus species. The product was distributed nationwide and consumers should stop using it.

    Product
    Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0651-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss

    CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·26V440000·2026-07-08

    Shyft Recalls Utilimaster Velocity Vehicles Due to Strobe Light Fire Risk

    Shyft Group is recalling 2016, 2019, and 2021 Utilimaster Velocity vehicles because water entering an improperly sealed strobe light may cause a short circuit and increase the risk of fire.

    Product
    UTILIMASTER — UTILIMASTER VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0661-2026·2026-07-08

    Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 30 mg tablets due to the presence of N-nitroso-cinacalcet above the acceptable daily intake. The affected product was distributed nationwide.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2026·2026-07-08

    CRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach

    Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices worldwide due to a potential sterile breach of the pouches in which the devices are packaged.

    Product
    CRE Wireguided 18-20mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2026·2026-07-08

    Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

    Medline is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2638-2026·2026-07-08

    Baxter Head Positioning Adapter May Loosen During Patient Positioning

    Baxter Healthcare is recalling an Adapter for Head Positioning (Model 1739994) used on operating tables because it may become loose and unintentionally move during patient positioning.

    Product
    Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2026·2026-07-08

    ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall

    Siemens Medical Solutions is recalling 119 units of the ARTIS icono ceiling (Model 11328100) due to potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits.

    Product
    ARTIS icono ceiling. Model Number: 11328100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0655-2026·2026-07-08

    Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance

    Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.

    Product
    PREDNISOLONE ACETATE — PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2026·2026-07-08

    Boston Scientific CRE Pro Wireguided catheters recalled for packaging

    Boston Scientific is recalling CRE Pro Wireguided 6-8mm 240cm catheters worldwide due to a potential sterile breach in the packaging pouches, which could compromise device sterility.

    Product
    CRE Pro Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide