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.

37851–37875 of 50506

  • HighFDA (Devices)·Z-2699-2015·2015-09-09

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY SURGICAL PACK 4/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2637-2015·2015-09-09

    Customed Urology Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 450 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UROLOGY SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2698-2015·2015-09-09

    Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2714-2015·2015-09-09

    Customed Arthroscopy PK L/F 5/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2518-2015·2015-09-09

    Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.

    Product
    KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2015·2015-09-09

    Trilliant Surgical Recalls Out-of-Specification Fibula Plates

    Trilliant Surgical Ltd. is recalling 28 units of VL Gridlock Fibula Plates because insufficient thread depth may limit locking screw functionality.

    Product
    7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2580-2015·2015-09-09

    Customed Recalls Pediatric Lap Packs Due to Sterilization Validation Issues

    Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.

    Product
    PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·15V566000·2015-09-08

    Hyundai Recalls 2009-2011 Accent Vehicles for Brake Light Switch Defect

    Hyundai is recalling approximately 99,500 2009-2011 Accent vehicles because a malfunctioning brake light switch may prevent brake lights from illuminating or disable cruise control.

    Product
    HYUNDAI — HYUNDAI ACCENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15751·2015-09-08

    Nestlé Recalls Water Dispensers Due to Fire Hazard

    Nestlé Waters North America is recalling about 190 water dispensers because screws holding the heat band can break, causing the unit to overheat and posing a fire hazard.

    Product
    Water dispensers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15235·2015-09-08

    IKEA Recalls VYSSA SPELEVINK Crib Mattresses for Fire Hazard

    IKEA is recalling VYSSA SPELEVINK crib mattresses because they fail to meet federal flammability standards, posing a fire hazard. No injuries have been reported.

    Product
    VYSSA SPELEVINK crib mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V564000·2015-09-04

    Thomas Built Buses Recall Wheelchair Lifts Due to Bearing Defect

    Daimler Trucks North America is recalling 2006-2015 Thomas Built Buses equipped with certain Ricon wheelchair lifts. Defective pivot holes may allow bearings to move, risking platform failure and injury.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER EF, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V565000·2015-09-04

    Thomas Built Buses Recall Wheelchair Lifts with Potential Bearing Failure

    Daimler Trucks North America is recalling 4,334 Thomas Built Buses equipped with specific Ricon wheelchair lifts due to a defect that could cause the platform to fall.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER FS65, SAF-T-LINER HDX, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15232·2015-09-03

    Prestone Windshield De-Icer and Ice & Frost Shield Recalled for Child Safety

    Prestone is recalling about 4.1 million bottles of windshield de-icer and frost shield because the trigger sprays can be removed, allowing children access to toxic chemicals.

    Product
    Prestone® Windshield De-Icer and Prestone® Ice & Frost Shield
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15231·2015-09-03

    Cannondale Mountain Bicycles Recalled for Stem Failure and Fall Risk

    Cycling Sports Group is recalling about 23,000 Cannondale mountain bicycles because the OPI stem/steering tube can fail, posing a risk of injury from a fall.

    Product
    Cannondale mountain bicycles with OPI stem/steering tube
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2015·2015-09-02

    Trilliant Surgical Reamer Heads Recalled for Guide Pin Fit Issues

    Trilliant Surgical Ltd. is recalling 638 Concave and Convex Reamer Heads because the cannulation may be too small to allow the Guide Pin to pass through freely.

    Product
    Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2015·2015-09-02

    Brainlab ExacTrac 6.0 Patient Positioning System Recalled for Display Error

    Brainlab AG is recalling ExacTrac 6.0.x software due to a potential display error in Digitally Reconstructed Radiographs used for x-ray correction.

    Product
    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2438-2015·2015-09-02

    Otto Bock Genium X3 Knee Joint Prosthesis Recalled for Hydraulic Failure

    Otto Bock Healthcare Products GmbH is recalling the Genium X3 knee joint prosthesis because its hydraulic resistance control may fail under certain conditions.

    Product
    Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2447-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2015·2015-09-02

    GE Healthcare Recalls Centricity Universal Viewer Software Due to Image Loss

    GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total…
    Category
    Medical Device
    Distribution
    Distributed nationwide