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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6651–6675 of 27393

  • HighFDA (Devices)·Z-0409-2024·2023-12-06

    Acumen IQ Sensor Intravascular Pressure Monitor Flushing Difficulty

    Edwards Lifesciences is recalling 33,327 Acumen IQ Sensors used for intravascular pressure monitoring due to potential flushing difficulties during setup. The devices are distributed across the US and internationally.

    Product
    Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0422-2024·2023-12-06

    RAPIDPOINT 500e Blood Gas System Recalled Due to Drug Interference

    Siemens RAPIDPOINT 500e blood gas systems may show falsely elevated sodium readings in patients taking Perhexiline Maleate or Atomoxetine, risking misdiagnosis and inappropriate treatment of electrolyte imbalances.

    Product
    RAPIDPOINT 500e Blood Gas System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2024·2023-12-06

    Breas Medical Ventilator Mouthpiece Recall: Unintended Slits May Reduce Ventilation

    Breas Medical is recalling 215 mouthpiece units due to manufacturing defects with unintended slits that may result in insufficient ventilation in mechanical ventilation patients.

    Product
    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2024·2023-12-06

    Da Vinci Needle Driver Recalled for Risk of Dislodgement During Surgery

    Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.

    Product
    Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0401-2024·2023-12-06

    SENTIERO Hearing Examination Device Recalled for Technical Distortions

    PATH recalls SENTIERO hearing examination devices for excessive technical distortions. Affected units are distributed in FL, MO, OH, and WI.

    Product
    SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0414-2024·2023-12-06

    Edwards TruWave pressure monitoring kit recalled for setup issues

    Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.

    Product
    TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0404-2024·2023-12-06

    Medical Device Recall: SENTIERO Hearing Screening Devices for Technical Distortions

    PATH's SENTIERO SCREENING hearing examination devices (Model SOH100098) are being recalled due to technical distortions that may exceed expected levels. The recall affects devices distributed in Florida, Missouri, Ohio, and Wisconsin.

    Product
    SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-0234-2024·2023-11-29

    VariSoft Insulin Infusion Set Recalled Over Premature Connector Disconnection

    Unomedical recalls 3,362 units of VariSoft infusion sets due to connector damage causing premature disconnection and missed insulin doses, risking dangerous elevation of blood glucose and ketone levels.

    Product
    VariSoft infusion set, Model Number 1002830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0233-2024·2023-11-29

    VariSoft Infusion Set Model 1002828 Recalled for Connector Detachment Risk

    The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.

    Product
    VariSoft infusion set, Model Number 1002828
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0232-2024·2023-11-29

    VariSoft Infusion Set recalled for defective connector prone to unintended disconnection

    Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.

    Product
    VariSoft infusion set, Model Number 1002827
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2024·2023-11-29

    V-Care manual resuscitators recalled for CO2 rebreathing defect

    SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.

    Product
    Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2024·2023-11-29

    Uretero-reno fiberscopes recalled due to inadequate channel drying

    Aizu Olympus is recalling uretero-reno fiberscopes because the channel air drying process was not validated. A small percentage of repaired devices had residual water in the channels, creating a risk of contamination and infection.

    Product
    Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2024·2023-11-29

    Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk

    Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.

    Product
    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2024·2023-11-29

    Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly

    Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.

    Product
    Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2024·2023-11-29

    Horizon manual resuscitators recalled for CO2 rebreathing hazard

    SunMed Holdings is recalling Ventlab Horizon manual resuscitators due to a backwards leak in the integrated manometer that allows carbon dioxide rebreathing. The affected devices were manufactured from September 2018 to the present and distributed nationwide.

    Product
    Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2024·2023-11-29

    Boston Scientific EXALT Model D Duodenoscope Recall: Fluid Ingress in Lens

    Boston Scientific is recalling certain EXALT Model D Single-Use Duodenoscopes worldwide due to fluid ingress in the lens, which causes poor image quality. Affected devices should not be used; contact the manufacturer.

    Product
    EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2024·2023-11-29

    Philips MRI systems recalled for potential gradient coil fire hazard

    Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.

    Product
    Intera 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2024·2023-11-29

    Hysterovideoscope Models Recalled Due to Improper Channel Drying Risk

    Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an infection risk.

    Product
    Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2024·2023-11-29

    BD Extension Sets Mislabeled as DEHP-Free Despite Containing Phthalates

    Certain BD Extension Sets sold as free of DEHP (di(2-ethylhexyl) phthalate) actually contain this restricted phthalate. The products have been distributed worldwide.

    Product
    BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2024·2023-11-29

    SafeSpot Manual Resuscitators Recalled for CO2 Rebreathing Risk

    SunMed Holdings is recalling SafeSpot manual resuscitators with integrated manometers due to a backwards leak that allows CO2 rebreathing. The defect affects multiple accessory configurations distributed nationwide.

    Product
    Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2024·2023-11-29

    Transnasal Esophagovideoscope Recalled Due to Unvalidated Drying Process

    Aizu Olympus is recalling the Transnasal Esophagovideoscope (Model PEF-V) because the channel air drying process was not validated, resulting in some units with wet channels that could cause infection.

    Product
    Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2024·2023-11-29

    Compress Device Short Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.

    Product
    Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2024·2023-11-29

    DBX Demineralized Bone Matrix Putty fill volume mislabeled

    DBX Demineralized Bone Matrix Putty units labeled as 10cc contain only 1cc of product, which may result in prolonged surgery. Affected units distributed in PA, TX, and WA.

    Product
    DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2024·2023-11-29

    Medtronic Mo.Ma Ultra Cerebral Protection Device Labeling Error

    Medtronic is recalling 173 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to incorrect labeling that prevents proper identification of inflation and deflation ports on the device manifold.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2024·2023-11-29

    Biomet Compress Device Short Anchor Plug Recalled Due to Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs (23 MM) due to potential metal burrs in transverse holes that may prevent proper insertion of surgical instruments, potentially extending surgery time. Distribution includes US and multiple international countries.

    Product
    Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
    Category
    Medical Device
    Distribution
    Distributed nationwide