The Recall Desk

State

South Dakota product recalls

72,966 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 72,966 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5801–5825 of 75647

  • HighFDA (Devices)·Z-2218-2025·2025-08-06

    Philips MR 7700 upgrade gradient coils may act as a heat source

    Upgrade to MR 7700 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 26 units are affected.

    Product
    Upgrade to MR 7700 Model Number (REF): 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2025·2025-08-06

    SmartPath to dStream 3.0T gradient coils may act as heat source

    SmartPath to dStream for 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 15 units affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2025·2025-08-06

    Philips Ingenia Elition X gradient coils may act as heat source

    Ingenia Elition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 632 units are affected.

    Product
    Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2025·2025-08-06

    Osteotec silicone finger implants may contain foreign material

    Osteotec Silicone Finger Implants in sizes 3, 4 and 5 are being recalled because there is the potential that the silicone implant may contain foreign material. 15,573 units are affected.

    Product
    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2025·2025-08-06

    Volcano Visions IVUS catheters can entangle with the guide wire

    Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.

    Product
    Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2025·2025-08-06

    Philips Ingenia Ambition X gradient coils may act as heat source

    Ingenia Ambition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 690 units are affected.

    Product
    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2025·2025-08-06

    Blood MacConkey biplates may carry Listeria monocytogenes surface contamination

    Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 units are affected.

    Product
    Blood/MacConkey Biplate 100/PK, Product Number R02049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2025·2025-08-06

    HeartSine samaritan public access defibrillators may not deliver shocks properly

    HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2025·2025-08-06

    Blood EMB Levine plates may carry Listeria monocytogenes contamination

    Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.

    Product
    Blood/EMB, Levine 100/PK, Product Number R02041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2025·2025-08-06

    Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

    Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.

    Product
    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2025·2025-08-06

    Philips MRI Machine Intera 3.0T Quasar Dual Recalled for Fire Risk

    Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.

    Product
    Intera 3.0T Quasar Dual Model Number (REF): 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2025·2025-08-06

    SwabFlush prefilled syringes carry SwabCaps with a compromised seal

    SwabFlush Prefilled Syringes with ICU Medical SwabCaps are being recalled because a manufacturing issue affects the SwabCap seal, which may reduce disinfection of the luer access valve. 1,427,100 units affected.

    Product
    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2025·2025-08-06

    SmartPath to Ingenia Elition X gradient coils may overheat

    SmartPath to Ingenia Elition X systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 33 units affected.

    Product
    SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2025·2025-08-06

    Philips Achieva XR gradient coils may act as a heat source

    Achieva XR MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 40 units are affected.

    Product
    Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2025·2025-08-06

    HarmonyAIR E-Series monitor yokes may detach from the spring arm

    Dual Flat Panel Monitor accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 59 units are affected.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2025·2025-08-06

    Blood agar plates may carry Listeria monocytogenes surface contamination

    Blood Agar with 5% Sheep Blood, product number R01202, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 1,552 units affected.

    Product
    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2025·2025-08-06

    LVP dual Y-site administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0381-2025·2025-08-06

    Pure Monk Fruit Sweetener bottles actually contain mislabeled stevia powder

    Pure Monk Fruit Sweetener, 0.71 oz, is being recalled because the product is stevia powder but the bottle was mislabeled as Pure Monk Fruit Sweetener. 78 bottles are affected.

    Product
    Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so much sweeter than sugar, a pinch is all you need. Suggested Use: Add to sweeten your food or be
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2025·2025-08-06

    BostonSight scleral lenses made with sagittal height or haptic errors

    BostonSight SCLERAL Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 441 units are affected.

    Product
    BostonSight SCLERAL Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2025·2025-08-06

    BostonSight PROSE lenses made with sagittal height or haptic errors

    BostonSight PROSE Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 38 units are affected.

    Product
    BostonSight PROSE Lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2219-2025·2025-08-06

    ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled

    ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.

    Product
    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

    Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2025·2025-08-06

    LYFO-DISK M. canis single packs may fail to recover the organism

    LYFO-DISK M. canis preparations, REF 0894L, are being recalled because they may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2025·2025-08-06

    Timolol eye drop caps can lodge a spike in the nozzle

    Timolol Maleate Ophthalmic Solution USP 0.5% is being recalled because of a defective container: the spike of the cap becomes lodged in the nozzle of the bottle. 154,176 bottles affected.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2025·2025-08-06

    LYFO-DISK M. canis multipacks may fail to recover the organism

    LYFO-DISK M. canis preparations in 6-pack and 2-pack formats are being recalled because they may result in failure to recover the target microorganism. 32 units are affected.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide