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.

26626–26650 of 50462

  • HighNHTSA·19V047000·2019-01-21

    Mack Trucks Recalls 2018 Anthem and Pinnacle Models for Clutch Defect

    Mack Trucks is recalling 2018 Anthem and Pinnacle vehicles because a clutch component may fail, causing unintended movement and increasing crash risk.

    Product
    MACK — MACK PINNACLE (CXU), ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V043000·2019-01-18

    Heartland Recalls 2019 Trailers Due to Incorrect Tire Certification Labels

    Heartland is recalling 2019 Prowler and Trail Runner trailers because their Federal Certification Labels may list incorrect tire size, load range, and pressure information.

    Product
    HEARTLAND — HEARTLAND TRAIL RUNNER, PROWLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2019·2019-01-16

    Agfa-Gevaert Recalls DX-D 600 Direct Radiography Systems Due to Movement Defect

    Agfa-Gevaert is recalling 10 DX-D 600 Direct Radiography Systems because the Overhead Tube Crane may continue moving after the control button is released.

    Product
    DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0387-2019·2019-01-16

    Allergan Recalls Ozurdex Dexamethasone Implants Due to Silicone Particulate

    Allergan is recalling 133,716 cartons of Ozurdex (dexamethasone) intravitreal implants because a silicone particulate was detected. The product was distributed to various accounts throughout the United States.

    Product
    OZURDEX — OZURDEX (DEXAMETHASONE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0694-2019·2019-01-16

    Philips Ingenia MRI Systems Recalled for Table Movement Safety Issue

    Philips is recalling Ingenia Elition S and X MRI systems because pressing the Stop Table button during automatic movement may cause the table to restart unexpectedly.

    Product
    Ingenia Elition S, Ingenia Elition X
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0695-2019·2019-01-16

    Ethicon Hemorrhoidal Circular Stapler Recalled for Missing Washer

    Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2019·2019-01-16

    GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Collimator Locking Hazard

    GE Healthcare is recalling 339 Discover VH/Millennium VG Nuclear Medicine Imaging Systems worldwide because a collimator locking handle may fail to engage, posing a potential hazard to patients during scans.

    Product
    Discover VH/Millennium VG Nuclear Medicine Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2019·2019-01-16

    Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer

    Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled Due to Incorrect Length Labeling

    Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the actual screw lengths do not match the labels.

    Product
    Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0698-2019·2019-01-16

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling seven Proteus 235 proton therapy systems due to a risk of detachment of the Compact Gantry Rolling Floor.

    Product
    Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2019·2019-01-16

    Elekta Unity MRI Speakers May Become Dislodged and Enter Bore

    Elekta Limited is recalling two Elekta Unity MRI systems because speakers can become dislodged and be pulled into the bore in rare circumstances.

    Product
    Elekta Unity
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0374-2019·2019-01-16

    PharMEDium Recalls Subpotent Buffered Lidocaine HCl Syringes Nationwide

    PharMEDium Services is voluntarily recalling 7,711 syringes of 0.9% Buffered Lidocaine HCl because the product was found to be subpotent.

    Product
    0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land…
    Category
    Drug
    Distribution
    0 states
  • HighNHTSA·19V031000·2019-01-14

    Ford Recalls 2019 Lincoln Nautilus for Lane Center Assist Defect

    Ford is recalling 2019 Lincoln Nautilus vehicles because the Lane Center Assist system may fail to detect if the driver's hands are off the steering wheel for a prolonged period.

    Product
    LINCOLN — LINCOLN NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.

    Product
    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.

    Product
    VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19E004000·2019-01-06

    WSB SC101 Motorcycle Helmets Recalled for Impact Protection Failure

    WSB Inc is recalling SC101 half-helmets manufactured in January 2018 because they may not adequately protect the wearer's head during an impact.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2019·2019-01-02

    Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise

    Medical Action Industries is recalling 2,600 laparotomy sponges because a breach of the sterile barrier may have compromised product sterility.

    Product
    Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0755-2019·2019-01-02

    Sargento Recalls Frozen Unbreaded Cheese Products for Listeria and Salmonella Risk

    Sargento Foods is recalling specific frozen unbreaded cheese products due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Frozen Unbreaded French onion / Swiss and Onion CC. Sample Number 17-0160.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
    Category
    Food
    Distribution
    3 states