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.

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.

4801–4825 of 75621

  • HighFDA (Devices)·Z-0201-2026·2025-10-22

    Non-DEHP Continu-Flo sets recalled from one lot because sets may leak

    Baxter is recalling 48,096 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2026·2025-10-22

    Shoulder surgical planning software recalled over possible implant malalignment risk

    Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.

    Product
    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative mea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2026·2025-10-22

    Preconnect pump devices recalled over inflation and deflation performance issues

    Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2026·2025-10-22

    Twelve foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 820 twelve-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2026·2025-10-22

    Dilation and curettage packs recalled after being sterilized more than once

    American Contract Systems is recalling D and C convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits IHDC30R D AND C PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2026·2025-10-22

    Cardiac Workstation 7000 recalled after pinched power module wire caused short

    Philips is recalling 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.

    Product
    Cardiac Workstation 7000; Model Number: 860441;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2026·2025-10-22

    Goniotomy instruments recalled over compromised sterile packaging integrity

    Iantrek is recalling 198 C-Rex UNO Microinterventional Goniotomy Instruments over the potential for compromised integrity of the sterile packaging.

    Product
    C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2026·2025-10-22

    Biopsy and laparoscopy packs recalled after being sterilized more than once

    American Contract Systems is recalling biopsy and laparoscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2026·2025-10-22

    Eye and cataract packs recalled after being sterilized more than once

    American Contract Systems is recalling cataract, eye, retinal and vitrectomy convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2026·2025-10-22

    Wound dressings recalled because foreign matter may be on the product

    ConvaTec is recalling 80,980 DuoDERM Extra Thin dressings from one lot because the wound dressing may have foreign matter on the product.

    Product
    DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2026·2025-10-22

    Parkinson's tablets recalled after bottles contained a higher strength tablet

    Rising Pharma is recalling 2,064 bottles of Carbidopa, Levodopa and Entacapone Tablets 25/100/200 mg after a sealed bottle was found to contain the 37.5/150/200 mg strength instead.

    Product
    CARBIDOPA, LEVODOPA AND ENTACAPONE — CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2026·2025-10-22

    Cardiovascular procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling cardiovascular convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2026·2025-10-22

    TENACIO pumps with InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling 59 TENACIO Pump with InhibiZone units, UPN 72404429, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump with InhibiZone; UPN: 72404429;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2026·2025-10-22

    Spine and laminectomy packs recalled after being sterilized more than once

    American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2026·2025-10-22

    Filtered solution sets recalled from one lot because IV sets may leak

    Baxter is recalling 106,176 CLEARLINK System Continu-Flo solution sets with a 0.2 micron filter from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2026·2025-10-22

    Gynecology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling gynecology, laparoscopy and hysteroscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2026·2025-10-22

    Orthopedic procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling shoulder, hip and extremity convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IAS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2026·2025-10-22

    LOGIQ P9 ultrasound systems recalled over inaccurate liver steatosis measurements

    GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2026·2025-10-22

    Omnipod 5 app recalled because magnifying a field duplicates typed digits

    Insulet is recalling 174,013 units of the Omnipod 5 iOS app because using the iPhone magnifier on a manual entry field while typing can duplicate a digit.

    Product
    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2026·2025-10-22

    CX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 2,288 CX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2026·2025-10-22

    Central line insertion kits recalled after being sterilized more than once

    American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.

    Product
    Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2026·2025-10-22

    Continu-Flo solution sets recalled across six lots because sets may leak

    Baxter is recalling 473,040 CLEARLINK System Continu-Flo solution sets across six lots because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2026·2025-10-22

    Radiology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling radiology convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide