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.

23051–23075 of 50430

  • HighFDA (Devices)·Z-2110-2020·2020-06-03

    Binding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error

    The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.

    Product
    Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
    Category
    Medical Device
    Distribution
    20 states
  • HighNHTSA·20V319000·2020-05-29

    GM Recalls 2019-2020 Chevrolet HD Trucks for ABS Warning Light Defect

    General Motors is recalling 2019-2020 Chevrolet 4500HD, 5500HD, and 6500HD trucks because the ABS malfunction light may fail to illuminate, increasing crash risk.

    Product
    INTERNATIONAL MOTORS — INTERNATIONAL MOTORS CHEVY 5500HD, CHEVY 4500HD, CHEVY 6500HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V311000·2020-05-28

    Keystone Recalls 2020 Springdale Trailers Due to Incorrect Tire Labeling

    Keystone RV Company is recalling 2020 Springdale trailers because the Federal Identification Tag lists incorrect tire load range and size, which could lead to tire overinflation or overloading.

    Product
    KEYSTONE — KEYSTONE SPRINGDALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2020·2020-05-27

    Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent

    Becton Dickinson & Co. is recalling BD BBL Gram Crystal Violet stain because increased artifacts may cause false-positive Gram stain results.

    Product
    BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V303000·2020-05-27

    Motorhome wire harness may damage fuel pump and brake systems

    Certain 2020-2021 Thor Motor Coach motorhomes may have a wire harness that contacts the frame, potentially damaging fuel pump and brake circuits and increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH AXIS, VEGAS, CHATEAU, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2020·2020-05-27

    Dako Autostainer Instruments Recalled for Potential False Negative Staining Results

    Dako is recalling 796 Autostainer instruments because a missing syringe tray may cause excess buffer application, potentially leading to false negative staining results.

    Product
    Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2020·2020-05-27

    Cardinal Health Recalls B-Hydroxybutyrate LiquiColor Due to Temperature Abuse

    Cardinal Health is recalling B-Hydroxybutyrate LiquiColor test kits because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2020·2020-05-27

    Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent

    Becton Dickinson is recalling BD BBL Gram Crystal Violet stain reagent because it may produce artifacts that look like gram-positive cocci, potentially causing false-positive test results.

    Product
    BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2020·2020-05-27

    Clinical Innovations Recalls Kiwi Vacuum Delivery System Due to Vacuum Failure

    Clinical Innovations, LLC is recalling 2,340 units of the Kiwi Complete Vacuum Delivery System because the device may fail to generate or maintain vacuum during use.

    Product
    Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2087-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2042-2020·2020-05-27

    Medline Silicone Foley Catheters Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling 330 units of 100% Silicone Foley Catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0970-2020·2020-05-27

    Willamette Valley Cherry Pie Recalled for Mislabeling as Raspberry Rhubarb

    Willamette Valley Pie Company is recalling Cherry Pies that are actually Raspberry Rhubarb Pies. The mislabeling creates a risk for consumers with almond allergies.

    Product
    Willamette Valley Pie Company Cherry Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as individual pies to consumers. UPC: 0 22518 87916 9. The label on a clamshell container is read in parts: "***HANDMADE All-Natural Cherry…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2014-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Interbody Spacer Systems Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Vascular Occlusion Failure

    Applied Medical Resources Corp is recalling 750 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2020·2020-05-27

    Innovasis Recalls Oryx Cervical Screw Caddies Due to Incorrect Labeling

    Innovasis is recalling six Oryx Cervical Screw Caddies because the labels for fixed and variable rescue screws are swapped. This mislabeling could lead to improper screw installation.

    Product
    Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20E032000·2020-05-27

    Akron Brass Recalls Wireless Firefighting Monitor Remote Controllers

    Akron Brass is recalling 53 wireless remote controllers for electric firefighting monitors because a disabled sleep mode causes batteries to discharge faster than normal.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress

    Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2020·2020-05-27

    Frames Direct Prescription Spectacle Lenses Recalled for Shatter Resistance Failure

    Frames Direct is recalling 87 pairs of prescription spectacle lenses that failed shatter resistance safety specifications, posing a risk of cracked or broken lenses.

    Product
    Frames Direct Prescription Spectacle Lenses included in the frame brands
    Category
    Medical Device
    Distribution
    36 states