The Recall Desk

State

South Dakota product recalls

73,190 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 73,190 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

14326–14350 of 75874

  • SevereFDA (Devices)·Z-0030-2024·2023-10-18

    2008T Hemodialysis System recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.

    Product
    2008T Hemodialysis System w/Bibag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2024·2023-10-18

    Syringes with Luer Lock Recalled for Blood Backfill and Foreign Material Risk

    Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.

    Product
    3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2024·2023-10-18

    Hemodialysis Machines Recalled Due to Potential PCBA Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.

    Product
    2008T HD SYS. CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs With Recalled Components

    Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2024·2023-10-18

    Knee Tibial Insert Recalled Due to Component Mix-Up in Packaging

    Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2024·2023-10-18

    Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use

    The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.

    Product
    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2024·2023-10-18

    Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift

    The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.

    Product
    Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V700000·2023-10-18

    BMW 750e and multiple 2023-2024 models recalled for steering wheel sensor defect

    BMW is recalling certain 2023-2024 models including the 750e due to a faulty ground connection in the steering wheel electrical system. The defect may render the hands-on detection system inoperative, preventing the emergency stopping assistant from engaging and increasing crash risk.

    Product
    BMW — BMW 740I, I5, I7, I7 M70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2024·2023-10-18

    Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall

    Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.

    Product
    Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2024·2023-10-18

    Multichem control vials break during shipping or thawing due to glass defect

    TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.

    Product
    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2024·2023-10-18

    Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms

    Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.

    Product
    Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2024·2023-10-18

    BD Pyxis CII Safe ES Software Flaw Disables Controlled Substance Safeguards

    Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.

    Product
    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2024·2023-10-18

    Glass Vials in Laboratory Control Products Recalled for Breakage Risk

    Multichem P and related laboratory control products are recalled due to defective glass vials that may break during delivery or use, potentially exposing users to biohazardous material.

    Product
    Multichem P, Part Code 08P90-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2024·2023-10-18

    Medfusion Syringe Pump Recalled for Occlusion Detection Calibration Drift

    Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.

    Product
    Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2024·2023-10-18

    Cardinal Health recalls Presource Fistulogram Packs with defective components

    Cardinal Health is recalling Presource Fistulogram Packs containing recalled components including equipment drapes and table covers. Approximately 13,351 sterile packs distributed across 33 US states and Canada are affected.

    Product
    Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2024·2023-10-18

    FDA Recalls Zemits NDPrime Yag Laser for Missing Safety Interlocks

    Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser nationwide due to failure to comply with radiation safety regulations. The device is missing critical safety interlocks and warning labels.

    Product
    MED-810A Zemits NDPrime Laser products
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2024·2023-10-18

    Multichem IA Plus and Controls Recalled Due to Broken Glass Vials

    TECHNO-PATH MANUFACTURING LTD. is recalling Multichem IA Plus and related controls due to broken glass vials that may expose laboratory personnel to biohazardous material. Affected lots should be discontinued immediately.

    Product
    Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0086-2024·2023-10-18

    Surgical procedure packs containing recalled equipment components distributed nationwide

    Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide that contain recalled components including equipment drapes and table covers.

    Product
    Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2024·2023-10-18

    EMPOWR hip acetabular implant packaging incorrectly contains knee implant component

    Encore Medical recalled 20 units of EMPOWR Acetabular System hip implant liners after knee implant components were mistakenly placed in hip surgery packages. Surgeons using the wrong implant could receive an anatomically incompatible component.

    Product
    EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs Due to Defective Components

    Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide and in Canada. The packs contain recalled equipment drapes, table covers, and surgical room turnover kits.

    Product
    Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0008-2024·2023-10-18

    LittleOak Goat Milk Infant Formula Recalled for Mixing Instructions Not in Ounces

    LittleOak Natural Goat Milk Infant Formula (Stage 1) is recalled due to mixing instructions not provided in ounces and lack of pre-market FDA notification. About 14,100 cans distributed nationwide are affected.

    Product
    LittleOak Natural Goat Milk Infant Formula (Stage 1); packaged in 800g (1.8lbs) tin cans - six cans per case.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-0109-2024·2023-10-18

    Surgical instrument button malfunction may extend operative time

    Olympus THUNDERBEAT surgical instruments may have a blue seal button that remains engaged after release, potentially extending surgery time. The company is recalling 271 affected units nationwide.

    Product
    THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0096-2024·2023-10-18

    GAMMEX NON-LATEX PI GREEN Surgical Gloves with Unsealed Sterile Pouches

    Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.

    Product
    GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2024·2023-10-18

    Surgical gloves recalled for incomplete sterile pouch sealing

    Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.

    Product
    NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide