The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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1051–1075 of 13464

  • HighFDA (Devices)·Z-1266-2026·2026-02-11

    FDA recalls Vivoo Vaginal pH Test for inaccurate diagnostic results

    The FDA is recalling Vivoo Vaginal pH Test kits distributed without FDA clearance. The tests may produce false or inaccurate results, potentially leading to inappropriate medical decisions.

    Product
    Vivoo Vaginal pH Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2026·2026-02-11

    Exploro Male Fertility Test Recalled for Inaccurate Diagnostic Results

    Changchun Wancheng Bio-Electron's Exploro male fertility test was distributed without required FDA clearance and may produce false or inaccurate results, potentially leading to inappropriate medical decisions.

    Product
    Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2026·2026-02-11

    Olympus Disposable Sphincterotome Recalled for Potential Performance Loss

    Olympus recalls 1,490 Disposable Triple Lumen Sphincterotomes due to a manufacturing defect where improper thermoforming could cause the devices to deform and lose performance during surgical use.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2026·2026-02-11

    Olympus Sphincterotome Recall: Risk of Device Deformation and Performance Loss

    Olympus is recalling sphincterotomes that did not undergo proper thermoforming, which could cause device deformation and loss of performance. The 5,089 affected units were distributed throughout the US and internationally.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2026·2026-02-11

    Vivoo Urine Test Strips Recalled for Inaccurate Diagnostic Results

    Vivoo Sodium, Vitamin C, and Hydration test strips distributed without FDA clearance may provide inaccurate diagnostic results, potentially leading to inappropriate medical intervention.

    Product
    Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2026·2026-02-11

    Molift Mover 300 mobile hoist recalled for bolt deformation defect

    ETAC A/S recalls Molift Mover 300 mobile hoists due to bolt deformation in the lifting bar joint that can prevent proper device functionality.

    Product
    Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2026·2026-02-11

    Diagnostic Cartridges Recalled for Inaccurate Alzheimer's Disease Test Results

    Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma test cartridges due to inaccurate test results that may falsely classify patients as having or requiring additional testing for Alzheimer's disease amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2026·2026-02-11

    Menopause Test Cassette Recalled for Risk of Inaccurate Diagnostic Results

    Menopause test cassette distributed before FDA approval recalled due to risk of false or inaccurate diagnostic results that could lead to inappropriate medical intervention.

    Product
    Menopause Test Cassette (Urine)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2026·2026-02-11

    Vortex Surgical Scleral Markers Recalled Due to Compromised Sterile Pouches

    Vortex Surgical is recalling Lindsell Sutured IOL Marker scleral markers due to potential voids in sterile pouches. Compromised seals could allow bioburden contamination that may lead to infection.

    Product
    Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2026·2026-02-11

    Vortex Surgical 25GA Convenience Kits Recalled for Compromised Sterile Barriers

    Vortex Surgical Inc. is recalling 25GA Convenience Kits due to potential voids in Tyvek pouch seals that could compromise sterility and lead to infection risk.

    Product
    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2026·2026-02-11

    FDA Recalls 3-Lumen Sphincterotome Devices for Deformation Risk

    Olympus has recalled its Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during endoscopic procedures.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2026·2026-02-11

    Single Use 3-Lumen Sphincterotome Recalled Due to Manufacturing Defect

    Olympus Corporation is recalling Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Some devices did not undergo thermoforming and could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2026·2026-02-11

    Sphincterotome V surgical instruments recalled for potential deformation

    Olympus is recalling 3,954 Single Use 3-Lumen Sphincterotome V devices due to a manufacturing defect where some units may have failed thermoforming, potentially causing deformation and loss of performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2026·2026-02-11

    Olympus Disposable Triple Lumen Sphincterotome Recall Due to Deformation Risk

    Olympus recalls Disposable Triple Lumen Sphincterotomes due to incomplete thermoforming that could cause device deformation and loss of performance. Affected units may not function properly during papillotomy procedures.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2026·2026-02-11

    Molift Mover 205 patient lift devices recalled due to structural bolt failure

    ETAC A/S is recalling 95 Molift Mover 205 patient lift devices due to a defective mounting bolt that can break and cause material deformation, limiting joint mobility and device functionality.

    Product
    Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2026·2026-02-11

    Molift 2-Point Sling Bars Recalled for Structural Bolt Failure

    ETAC A/S is recalling Molift 2-point sling bars due to bolts breaking during assembly and testing. The defect causes material deformation that prevents proper functionality in this assistive device.

    Product
    Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2026·2026-02-11

    Robotic surgical systems recalled for undetected arm defects

    Intuitive Surgical recalled da Vinci X, Xi, and 5 surgical systems due to a software error that failed to detect bent manipulator arms. The faulty arms pose a risk of failure during surgery.

    Product
    Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1291-2026·2026-02-11

    Olympus Sphincterotome Devices Recalled for Potential Deformation and Performance Loss

    Olympus is recalling Single Use 3-Lumen Sphincterotome V devices that may not have undergone proper thermoforming, which could cause deformation and performance loss during use.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2026·2026-02-11

    Volk Single Use Vitrectomy Lenses Recalled for Compromised Sterile Barrier

    Vortex Surgical Inc. is recalling Volk Single Use Vitrectomy Lenses due to voids in Tyvek pouch seals that could compromise the sterile barrier and lead to infection.

    Product
    Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2026·2026-02-11

    Olympus Sphincterotome Devices May Deform Due to Manufacturing Defect

    Olympus is recalling Single Use 3-Lumen Sphincterotomes that may deform if not properly thermoformed during manufacturing, potentially losing performance during use. No illnesses have been reported.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2026·2026-02-11

    Olympus Sphincterotome Devices Recalled for Manufacturing Defect in Thermoforming Process

    Olympus recalls 1,504 Single Use Sphincterotome V devices due to incomplete thermoforming. Affected devices could deform and lose performance during surgical use.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2026·2026-02-11

    Olympus Sphincterotome Recall Due to Potential Deformation and Performance Loss

    Olympus is recalling 1,474 units of the Single Use 3-Lumen Sphincterotome V distributed outside the US. Some devices may not have undergone proper thermoforming, which could cause deformation and performance loss.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2026·2026-02-11

    Prismaflex M150 dialyzer sets recalled for deaeration chamber dislodgement

    VANTIVE US HEALTHCARE LLC is recalling 137,576 Prismaflex M150 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit. No injuries have been reported.

    Product
    PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2026·2026-02-11

    Dialyzer Deaeration Chamber Potential Dislodgement Prompts Safety Recall

    VANTIVE's PRIMSAFLEX M100 dialyzer sets may have a deaeration chamber that could dislodge from the control unit. Approximately 230,596 units distributed nationwide are affected.

    Product
    PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2026·2026-02-11

    Surgical Laser Probes Recalled Due to Compromised Sterile Barrier Seals

    Vortex Surgical laser probes are recalled for voids in sterilization pouches that compromise sterility and could allow bioburden contamination leading to infection. Multiple probe models are affected across the US and internationally.

    Product
    Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25
    Category
    Medical Device
    Distribution
    Distributed nationwide