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 the agency’s own highest classification or reported deaths or serious injuries, 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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16601–16625 of 27505

  • HighFDA (Devices)·Z-0462-2019·2018-11-21

    Invivo Xper Flex Cardio Physiomonitoring System Software Recall

    Invivo Corporation is recalling 76 units of the Xper Flex Cardio Physiomonitoring System due to a software defect that causes Invasive Blood Pressure values to freeze on the display.

    Product
    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0424-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0421-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 4x8cm devices because the PGA suture material degraded, causing the devices to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0418-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0427-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0416-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.

    Product
    OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0428-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Devices

    AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0419-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 16x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.

    Product
    OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0423-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0431-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.

    Product
    OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0452-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia Systems for Missing Backup Ventilation Feature

    GE Healthcare is recalling Aisys anesthesia systems because a software upgrade prevents the device from automatically switching to backup ventilation if a patient stops breathing.

    Product
    Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 18x22cm devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0461-2019·2018-11-21

    Medtronic Recalls Parietex Composite Parastomal Mesh Due to Failure Reports

    Medtronic is voluntarily removing Parietex Composite Parastomal Mesh from the market after receiving reports of product failure leading to hernia recurrence.

    Product
    Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 20x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.

    Product
    OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0454-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0433-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0412-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia Systems Due to Ventilation Mode Defect

    GE Healthcare is recalling Aisys anesthesia systems because they may fail to transition to backup ventilation if a patient stops breathing spontaneously.

    Product
    Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 4x8cm devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0439-2019·2018-11-21

    Stryker Spirit Select Bed Recall for Potential Entrapment Risk

    Stryker is recalling Spirit Select Beds with high rail siderails due to non-compliance with safety standards and a potential risk of entrapment.

    Product
    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
    Category
    Medical Device
    Distribution
    50 states
  • CriticalFDA (Devices)·Z-0269-2019·2018-11-14

    OriGen Reinforced Dual Lumen Cannula Recalled for Potential Tube Separation

    OriGen Biomedical is recalling 134 units of the VV19F Reinforced Dual Lumen Cannula because the extension tube may separate from the hub, posing a risk of blood loss.

    Product
    REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during…
    Category
    Medical Device
    Distribution
    Distributed nationwide