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.

21476–21500 of 50426

  • HighFDA (Devices)·Z-0621-2021·2020-12-23

    Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.

    Product
    Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2021·2020-12-23

    Mizuho Microsurgical Operating Room Tables Recalled for Unintended Movement

    Mizuho America is recalling 10 microsurgical operating room tables due to unintended tilting and infrared signal errors that may cause incorrect operation.

    Product
    Microsurgical Operating Room Tables;7300BX (18-351-70).
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0633-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach

    Maquet Cardiovascular is recalling the HLS Set Advanced because of breaches in the product's sterility barrier. The device is used with the CARDIOHELP system for cardiac and pulmonary support.

    Product
    HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches

    Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.

    Product
    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2021·2020-12-23

    Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile packaging seal could lead to loss of sterility.

    Product
    4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0628-2021·2020-12-23

    Biomet Hip Prosthesis Recall for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RINGLOC BIPOLAR Hip System components due to a potential breach in the sterile seal, which could lead to loss of sterility.

    Product
    RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2021·2020-12-23

    BD PrecisionGlide Needles Recalled Due to Blood Contamination

    Becton Dickinson is recalling BD PrecisionGlide needles because blood was found on the cannulas, posing a potential infection risk if not noticed by clinicians.

    Product
    BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V810000·2020-12-23

    International DuraStar and WorkStar Engine Control Software Defect Recall

    Navistar recalls 17,213 2014-2021 International commercial trucks with an engine control defect. The software flaw can cause unexpected vehicle movement when parked with the PTO engaged, risking crashes and injury.

    Product
    INTERNATIONAL — INTERNATIONAL WORKSTAR, DURASTAR, MV, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0636-2021·2020-12-23

    Kowa VK-2s Software Recall for Potential Patient Data Deletion

    Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.

    Product
    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V811000·2020-12-23

    GM Recalls Bolt EV and Other Vehicles for Seat Belt Attachment Defect

    General Motors is recalling multiple 2020-2021 vehicles due to incorrect bolts used to secure seat belts. Improperly fastened seat belts may fail to properly restrain occupants in a crash.

    Product
    CHEVROLET — CHEVROLET, CADILLAC, GMC SUBURBAN, ESCALADE NA, COLORADO, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2021·2020-12-23

    Terumo Capiox FX25 Advance Oxygenator Recall for Configuration Error

    Terumo is recalling Capiox FX25 Advance Oxygenators because they may have the incorrect East or West configuration. The recall affects 5,079 units distributed in the US and abroad.

    Product
    (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V809000·2020-12-22

    Escape Trailer Recalls 2020 RVs Due to Gas Leak Risk

    Escape Trailer is recalling 2020 RV trailers because a stove component may cause a gas leak, increasing the risk of fire.

    Product
    ESCAPE — ESCAPE ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21715·2020-12-22

    2021 Can-Am Outlander and Renegade ATVs Recalled for Rear Wheel Separation

    Bombardier Recreational Products is recalling 2021 Can-Am Outlander and Renegade ATVs because a rear wheel can separate, causing a crash hazard.

    Product
    2021 Can-Am Outlander and Renegade All-Terrain Vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V807000·2020-12-21

    2021 FCCC Trucks Recalled: Brake Caliper Tie Bar Fasteners May Be Loose

    DTNA recalls certain 2021-2022 commercial trucks with potentially loose or missing brake caliper tie bar fasteners, which could affect brake function and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC, THOMAS BUILT BUSES BUSINESS CLASS M2, MC, MBC, MT55
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E092000·2020-12-21

    Bendix Brake Light Switch Recall Due to Potential Jamming

    Bendix is recalling specific brake light pressure switches that may leak air, causing electrical contacts to jam and brake lights to malfunction.

    Product
    EXTERIOR LIGHTING:BRAKE LIGHTS:SWITCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V803000·2020-12-21

    Volvo Bus Recalls 2015-2020 9700 Models for Transmission Hub Failure

    Volvo Bus is recalling 2015-2020 9700 buses because a transmission hub may fail, potentially disabling the vehicle and forcing passengers to transfer on the roadside.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V805000·2020-12-21

    SVI Trucks Recalls 2020 Fire Rescue Trucks Due to Display Lockup

    SVI Trucks is recalling 2020 Fire Rescue Trucks because the instrument cluster display may lock up, potentially delaying emergency efforts and increasing injury risk.

    Product
    SVI TRUCKS — SVI TRUCKS SVI TRUCKS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V806000·2020-12-21

    2022 Thomas Built Buses Brake Tie Bar Installation Defect Recall

    Daimler Trucks recalls 278 model year 2022 Thomas Built SAF-T-Liner C2 school buses due to improper brake tie bar installation. The defect could increase crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V799000·2020-12-18

    2021 Forest River Puma Travel Trailers: Fire Risk from Propane Cooktop

    Forest River is recalling certain 2021 Puma travel trailers because the outdoor cooktop may be stowed with the propane hose still attached and burner on, increasing fire risk. Forest River will install a bracket to prevent the drawer from being closed while the propane line is attached.

    Product
    FOREST RIVER — FOREST RIVER PUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V801000·2020-12-18

    2021 Keystone Cougar Recreational Trailers Recalled for Solar Wiring Defect

    Certain 2021 Keystone Cougar recreational trailers with Solar Prep wiring may have improper electrical connections that increase fire risk. Owners should contact Keystone for free inspection and remounting of the wiring.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V800000·2020-12-18

    Mercedes-Benz Recalls AMG GT53 and GT63 for Detaching Wheel Hub Caps

    Mercedes-Benz is recalling 2019-2020 AMG GT53 and GT63 vehicles because wheel-hub caps may detach while driving, creating a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT63, AMG GT53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V788000·2020-12-17

    2020-2021 Ford Explorer and Lincoln Aviator motor mount fastener recall

    Ford is recalling certain 2020-2021 Explorer and Lincoln Aviator vehicles because right-hand motor mount fasteners may have been incorrectly tightened and could loosen, potentially causing the axle to disconnect from the engine and loss of power.

    Product
    LINCOLN — LINCOLN, FORD AVIATOR, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide