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.

43526–43550 of 50511

  • HighFDA (Devices)·Z-1404-2013·2013-06-05

    Canon RK-F2 Ref-Keratometer Recalled for Abnormal Refractive Power Readings

    Canon Inc. is recalling 384 RK-F2 Ref-Keratometers because the device may display abnormal refractive power values in approximately 5% of cases.

    Product
    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-462-2013·2013-06-05

    Nora Apothecary Recalls Trimix Penile Injection Due to Sterility Concerns

    Nora Apothecary is recalling 72 units of Trimix Penile Injection nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 414 Aliquot Plungers because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2013·2013-06-05

    Fisher & Paykel Recalls ICON CPAP Units Due to Power Issue

    Fisher & Paykel Healthcare is recalling 1,407 ICON CPAP units because they may become inoperable, interrupting treatment for obstructive sleep apnea.

    Product
    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-476-2013·2013-06-05

    HCG Injection Recalled Due to Sterility Assurance Concerns

    Nora Apothecary and Alternative Therapies, Inc. recalled HCG injection products because FDA inspection findings raised concerns about quality control and sterility assurance. The products were distributed nationwide.

    Product
    HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2013·2013-06-05

    Heart Sync Recalls Radiotransparent Defibrillation Electrodes Due to Equipment Damage

    Heart Sync, Inc. is recalling Vermed Radiotransparent Defibrillation Electrodes because a supplier defect may prevent the device from delivering appropriate electrical shocks to patients.

    Product
    Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1433-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Fenestrated Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.

    Product
    8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2013·2013-06-05

    Heart Sync C100-Physio Defibrillation Electrodes Recalled for Potential Energy Delivery Failure

    Heart Sync, Inc. is recalling C100-Physio defibrillation electrodes due to a supplier issue that may prevent the device from delivering appropriate electrical shocks.

    Product
    Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1438-2013·2013-06-05

    TZ Medical Recalls Defibrillation Electrodes Due to Defective White Wire

    TZ Medical Inc. is recalling P-211-M1 and P-214-M1 defibrillation electrodes because they may contain a defective white wire on the connector assembly.

    Product
    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2013·2013-06-05

    Alphatec Recalls Leucadia Autolok Pedicle Screw System Due to Tolerancing Issue

    Alphatec Spine is recalling the Leucadia Autolok Polyaxial Pedicle Screw System because a tolerancing issue may prevent the rod from locking rigidly, potentially compromising spinal stability.

    Product
    Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2013·2013-06-05

    Elekta Integrity 3.0 Multileaf Collimator Recalled for Beam Delivery Tolerance Issues

    Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.

    Product
    Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2013·2013-06-05

    Beckman Coulter Recalls AU2700 and AU5400 Clinical Chemistry Analyzers

    Beckman Coulter is recalling AU2700 and AU5400 Clinical Chemistry Analyzers because tubing connections may leak concentrated detergent.

    Product
    AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2013·2013-06-05

    PTS Glucose Test Strips Recalled for Under-Recovery of Glucose

    Polymer Technology Systems is recalling PTS Glucose Test Strips because internal testing showed under-recovery of glucose, which could lead to inaccurate readings.

    Product
    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.

    Product
    8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V240000·2013-06-04

    Chrysler Recalls 2013 Ram Trucks for Headlight Shutter Defect

    Chrysler is recalling 2013 Ram 2500 and 3500 trucks because headlamp shutters may malfunction in high-beam mode, potentially blinding oncoming traffic.

    Product
    RAM — RAM 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V236000·2013-06-04

    Mercedes-Benz Recalls 2013 SLK250 and SLK350 for Airbag System Defect

    Mercedes-Benz is recalling 2013 SLK250 and SLK350 vehicles because the occupant classification system may fail to detect light passengers, potentially deactivating the airbag.

    Product
    MERCEDES-BENz — MERCEDES-BENz, MERCEDES-BENZ SLK250, SLK350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V230000·2013-05-31

    Ford Recalls 2013 Lincoln MKZ Vehicles for Engine Block Heater Defect

    Ford is recalling 2013 Lincoln MKZ vehicles equipped with engine block heaters because the cord insulation may crack, exposing wires and increasing the risk of electric shock.

    Product
    LINCOLN — LINCOLN MKZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2013·2013-05-29

    Separation Technology Recalls SlidePrep Plus Cytology Centrifuges for Unexpected Startup

    Separation Technology, Inc. is recalling SlidePrep Plus Cytology Centrifuges manufactured before January 1, 2013, because they may start up unexpectedly when exposed to electrostatic discharge.

    Product
    SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2013·2013-05-29

    Roche Cobas 8000 Software Recall for Incorrect Immunoassay Results

    Roche Diagnostics is recalling software for the cobas e 602 module because it may produce incorrect test results under specific conditions.

    Product
    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13204·2013-05-29

    Pottery Barn Kids Recalls Sweet Lambie Crib Bumpers Due to Entanglement Hazard

    Pottery Barn Kids is recalling Sweet Lambie Crib Bumpers because loose stitching can entangle infants. Consumers should stop using affected bumpers and contact the company for a refund or replacement.

    Product
    Sweet Lambie Crib Bumper
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13735·2013-05-29

    Hammary Furniture Recalls Dining Side Chairs Due to Fall Hazard

    Hammary Furniture is recalling about 165 dining side chairs because the leg connections can flex, posing a fall hazard. No injuries have been reported.

    Product
    Abaca and Wood Dining Side Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide