The Recall Desk

State

South Dakota product recalls

72,992 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.

Which agencies issued them

These figures cover only the 2,681 recalls whose distribution notice names South Dakota specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9051–9075 of 75673

  • HighFDA (Devices)·Z-0251-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801452) due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination. Approximately 4,818 units are affected.

    Product
    SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.

    Product
    SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2025·2024-11-06

    Covidien Chameleon PTA Balloon Catheter Recalled for Failed Pressure Testing

    Covidien is recalling specific lots of its Chameleon PTA Balloon Catheter that failed in-house pressure testing. The affected catheters were distributed worldwide to the US and 18 countries.

    Product
    Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication

    King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.

    Product
    KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2025·2024-11-06

    Codman Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences has recalled Codman Surgical Patties and Strips (Model 801407) due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification endotoxin in finished products used in brain surgery.

    Product
    SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2025·2024-11-06

    Integra Recalls Surgical Patties and Strips Due to Endotoxin Levels

    Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.

    Product
    SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2025·2024-11-06

    FDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance

    King Systems Corp. is recalling 21,591 KING LTSD airway kits nationwide. The devices were distributed with an unauthorized indication for pediatric use that exceeds FDA regulatory authorization.

    Product
    KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2025·2024-11-06

    Ambu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk

    Ambu is recalling VivaSight 2 DLT endotracheal tubes due to hyper angulation of the distal end, which increases risk of intubation complications and airway injury.

    Product
    Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2025·2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.

    Product
    SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2025·2024-11-06

    Laryngeal Tube Device Recalled for Unapproved Pediatric Indication

    King Systems Corp. is recalling 21,939 KING LTSD laryngeal tubes nationwide because the device was marketed for pediatric use without proper FDA regulatory clearance. The device was originally approved only for adult use.

    Product
    KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0248-2025·2024-11-06

    Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin

    Integra LifeSciences is recalling surgical patties and strips (Model 801449) due to higher-than-expected endotoxin levels in raw materials that may have resulted in out-of-specification finished products.

    Product
    SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0030-2025·2024-11-06

    Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination

    Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2025·2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels in raw materials

    Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0027-2025·2024-11-06

    Cinacalcet tablets recalled for nitroso impurity above FDA limits

    Dr. Reddy's Laboratories is recalling Cinacalcet 60 mg tablets nationwide because testing detected N-nitroso impurity exceeding FDA interim limits. The recall affects 35,880 bottles.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2025·2024-11-06

    Surgical patties recalled due to higher-than-expected endotoxin levels

    Integra LifeSciences Corp. is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may have resulted in out-of-specification finished products used during surgery.

    Product
    SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2025·2024-11-06

    Olympus Endoscopic Flushing Pump Recalled Due to Function Loss

    Olympus is recalling the OFP-2 Endoscopic Flushing Pump due to intermittent loss of function caused by internal component connection failure. Approximately 445 units distributed nationwide are affected.

    Product
    Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0269-2025·2024-11-06

    AMBU King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Indication

    King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways because they were marketed for pediatric use without FDA clearance for that indication. The device exceeded its 510(k) exemption limitations.

    Product
    AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2025·2024-11-06

    Olympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error

    Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.

    Product
    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2025·2024-11-06

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity

    Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2025·2024-11-06

    Surgical Patties and Strips recalled for endotoxin contamination in raw materials

    Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.

    Product
    SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0026-2025·2024-11-06

    Cinacalcet tablets recalled for manufacturing impurity exceeding FDA limits

    Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0032-2025·2024-11-06

    Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits

    Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2025·2024-11-06

    Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.

    Product
    SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials used during manufacturing. The affected devices were distributed worldwide to healthcare facilities.

    Product
    SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide