The Recall Desk

State

South Dakota product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3801–3825 of 75621

  • HighFDA (Devices)·Z-0971-2026·2025-12-31

    Femoral nails, 400 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509400, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2026·2025-12-31

    Femoral nails, 440 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509440, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2026·2025-12-31

    Femoral nails, 400 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609400, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2026·2025-12-31

    Dialysis concentrate 100220 recalled because safety and efficacy cannot be assured

    Diasol is recalling 4400 gallons of liquid concentrate for bicarbonate dialysis, product 100220-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2026·2025-12-31

    Femoral nails, 340 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609340, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2026·2025-12-31

    Campylobacter control kits recalled because they may fail to recover the organism

    Microbiologics is recalling 86 KWIK-STIK 2-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0963-2026·2025-12-31

    Cranial tracker devices recalled over an error message preventing use

    Howmedica Osteonics is recalling 320 Stryker CranialMask Trackers because activating the device during surgery produces an error message that makes the device unusable.

    Product
    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2026·2025-12-31

    Campylobacter six-pack control kits recalled over failure to recover the organism

    Microbiologics is recalling 18 KWIK-STIK 6-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2026·2025-12-31

    Campylobacter LYFO DISK controls recalled over failure to recover the organism

    Microbiologics is recalling LYFO DISK units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V913000·2025-12-29

    Gillig Recalls 2025 Low Floor Buses Due to Loose Axle Fasteners

    Gillig is recalling 2025 Low Floor transit buses because improperly tightened rear axle fasteners may cause component damage and increased crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0915-2026·2025-12-24

    Anesthesia power management boards recalled over potential unexpected system shutdown

    GE Medical Systems is recalling 203 Carestation anesthesia system Power Management Board field replaceable units over potential unexpected shutdown if AC mains power is lost.

    Product
    GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0914-2026·2025-12-24

    Carestation 750 anesthesia systems recalled over potential unexpected shutdown

    GE Medical Systems is recalling 888 Carestation 750 series anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The action is Class I.

    Product
    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0913-2026·2025-12-24

    Anesthesia systems recalled over potential unexpected shutdown on mains power loss

    GE Medical Systems is recalling 1,277 Carestation anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The FDA has classified the action as Class I.

    Product
    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2026·2025-12-24

    Insulin pen app recalled over notifications lost after reinstalling the app

    Medtronic MiniMed is recalling 8,251 units of the InPen App for Android because reinstalling the app deletes the notification override permission, so audible and vibratory alerts are not received.

    Product
    InPen App, Model/CFN Number: MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0922-2026·2025-12-24

    Sterile Kelly forceps recalled over weak seals that may breach sterility

    Medline is recalling 53 sterile Kelly forceps because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2026·2025-12-24

    Central monitoring workstations recalled over audio failure and screen freezing

    Mindray is recalling 906 BeneVision Distributed Monitoring System units because a specific workstation hardware configuration may experience audio playback failure or screen freezing.

    Product
    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25C011000·2025-12-24

    Evenflo Recalls All4One Child Seats Due to Recline Mechanism Defect

    Evenflo is recalling certain All4One child seats because the recline mechanism may shift out of position, potentially failing to secure a child in a crash.

    Product
    CHILD SEAT:BASE:RECLINE MECHANISM recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2026·2025-12-24

    Imaging viewer software recalled over inaccurate length measurement values

    DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.

    Product
    Intelerad InteleShare software, with ProViewer component
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0921-2026·2025-12-24

    Sterile operating room scissors recalled over weak seals affecting sterility

    Medline is recalling 56 sterile operating room scissors because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2026·2025-12-24

    Children's mouthguards recalled for distribution without FDA premarket clearance

    Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.

    Product
    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2026·2025-12-24

    Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results

    Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0957-2026·2025-12-24

    Bone fixation screws recalled over a labeling error on one lot

    Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.

    Product
    BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
    Category
    Medical Device
    Distribution
    Distributed nationwide