The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

26901–26925 of 50462

  • HighFDA (Devices)·Z-0441-2019·2018-11-21

    R82 A/S Recalls Heron Toilet and Bath Chairs Due to Aluminum Gas Spring

    R82 A/S is recalling 687 Heron toilet and bath chairs because they contain aluminum gas spring heads. The recall is a replacement campaign for these specific units.

    Product
    Heron toilet and bath chair Model 880505-01 & 880505-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 16x20cm devices because the PGA suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0258-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 18,832 bottles of Isosorbide Dinitrate 20 mg tablets due to cross-contamination with other products.

    Product
    ISOSORBIDE DINITRATE — ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0429-2019·2018-11-21

    Wornick Company Recalls Fire Roasted Onion and Pepper Blend

    The Wornick Company is recalling Chef Sensations Fire Roasted diced onion/pepper blend due to potential Salmonella and Listeria contamination.

    Product
    Chef Sensations Fire Roasted 1/2" diced onion/pepper blend Net Wt 20 lbs
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-0422-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold 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 6x10cm, Part Number F10256-0610G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0442-2019·2018-11-21

    Arthrex Recalls 3.2mm Proximal Reamer Due to Potential Breakage During Use

    Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill because the instrument may break during use.

    Product
    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill…
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0456-2019·2018-11-21

    American Contract Systems Recalls Powdered Surgical Gloves

    American Contract Systems is recalling 1,180 kits of powdered surgical gloves because they are an FDA banned substance.

    Product
    Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0451-2019·2018-11-21

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

    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 125 Deg 10x165mm, Item Number 816710165 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-0445-2019·2018-11-21

    Luminex Recalls Verigene Blood Culture Gram-Positive Nucleic Acid Kits

    Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits due to a potential for false negative results.

    Product
    VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2019·2018-11-21

    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 10x12cm, Part Number F10258-1012G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0432-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

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

    Product
    OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0469-2019·2018-11-21

    Tosoh AIA-900 Analyzer Recalled Due to Pickup Arm Malfunction

    Tosoh Bioscience is recalling 393 AIA-900 Analyzers because a pickup arm malfunction can stop the device from testing patient samples, causing delays in results.

    Product
    AIA-900 Analyzer, Product code 022930, 022930R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails 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 Left 130 Deg 11x300mm, Item Number 814611300 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-0430-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

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

    Product
    OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
    Category
    Medical Device
    Distribution
    8 states
  • 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 (Food)·F-0622-2019·2018-11-21

    Rojo's Autentico Black Bean 5 Layer Dip Recalled for Contamination Risk

    Simply Fresh Foods is recalling Rojo's Autentico Black Bean 5 Layer Dip due to potential Salmonella or Listeria monocytogenes contamination in the corn.

    Product
    Rojo's Autentico Black Bean 5 Layer Dip; Layers of Black Beans, Guacamole, Salsa, sour Cream and Cheddar Cheese. NET WT. 40 oz. (2 Lbs. 9 oz.) 1.13 kg UPC: 047502 441269 Simply Fresh Foods, Inc., Buena Park, Ca 9-620 WWW Rojossalsa.com
    Category
    Food
    Distribution
    12 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