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.

11826–11850 of 22152

  • HighFDA (Devices)·Z-1544-2024·2024-04-24

    Neria Soft Infusion Sets recalled due to incorrect instruction manual

    Unomedical A/S is recalling 10,770 units of Neria Soft Infusion Sets because certain lots were shipped with incorrect instructions for use. The wrong instruction manual for Rest of World markets was included instead of the FDA-approved US version.

    Product
    Neria Soft Infusion Set, Product Code 507302, intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2024·2024-04-24

    POLYSIN Surgical Sutures Recalled for Incorrect Needle Curvature Defect

    Surgical Specialties is recalling POLYSIN (Polyglycolic Acid) surgical sutures due to incorrect needle curvature. This defect could affect proper suture placement during surgical procedures.

    Product
    POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1577-2024·2024-04-24

    Philips Intera 1.5T MRI Patient Support Table Floor Plate Installation Defect

    Philips is recalling 46 units of the Intera 1.5T Achieva Nova MRI system due to improper installation of the patient support table floor plate. The defect may compromise patient safety during use.

    Product
    Intera 1.5T Achieva Nova, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1575-2024·2024-04-24

    Philips MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips is recalling 347 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed, potentially compromising patient support stability during use.

    Product
    Intera 1.5T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2024·2024-04-24

    MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.

    Product
    GYROSCAN T5-NT, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0445-2024·2024-04-24

    Eli Lilly Recalls Humalog Sterile Diluent Due to Manufacturing Deviations

    Eli Lilly & Company has voluntarily recalled 700 vials of Humalog sterile diluent due to Current Good Manufacturing Practice (CGMP) deviations. The affected batch (D608951C, exp. 4/10/2025) was distributed nationwide.

    Product
    HUMALOG — HUMALOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2024·2024-04-24

    RENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk

    Smith & Nephew is recalling RENASYS EDGE 800ML canisters due to black particulate matter from the carbon filter potentially damaging the NPWT pump. Affected patients should contact their healthcare provider.

    Product
    RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2024·2024-04-24

    Peel-Away Introducer medical devices recalled for low packaging seal strength

    Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.

    Product
    Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2024·2024-04-24

    Magnetic Resonance System patient support table floor plate installation defect

    Philips has recalled Intera 1.5T Achieva Nova-Dual MRI systems due to incorrect installation of the patient support table floor plate. The recall affects 20 units distributed worldwide.

    Product
    Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2024·2024-04-24

    Philips MRI System Patient Support Table Floor Plate Installation Issue

    Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.

    Product
    Intera 3.0T Quasar Dual, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2024·2024-04-24

    Microalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification

    Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24201·2024-04-18

    Gasaciods Children's Multi-Purpose Helmets Recalled for Head Injury Risk

    Gasaciods children's helmets sold on Temu.com fail to meet federal safety standards for bicycle helmets and do not adequately protect against head injury in a crash. Consumers should stop using them immediately.

    Product
    Gasaciods Children's Multi-Purpose Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24202·2024-04-18

    Randder Liquid Fuel Bottles Recalled for Non-Child-Resistant Closure

    Randder 2-Pack Liquid Fuel Bottles in 750mL and 1500mL sizes sold on Amazon are recalled because their closures do not meet child-resistant requirements under the Children's Gasoline Burn Prevention Act, posing a risk of burns and poisoning to children.

    Product
    Randder 2-Pack Liquid Fuel Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24203·2024-04-18

    Gossamer Pro AGX+ Bicycle Cranksets Recalled for Fall Injury Risk

    Full Speed Ahead is recalling Gossamer Pro AGX+ cranksets that can loosen or detach from bicycles, creating a fall hazard. The company has received 277 reports of loosening or detachment but no injuries to date.

    Product
    Gossamer Pro AGX+ cranksets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2024·2024-04-17

    Feeding tube kit recalled due to blocked connector preventing guidewire advancement

    Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.

    Product
    EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1127-2024·2024-04-17

    Yellow onions recalled due to incomplete botulinum hazard analysis

    Pueblo Fruits is recalling 23 cases of yellow onions sold to a single restaurant in Albuquerque because the firm did not complete a hazard analysis for potential Clostridium botulinum growth in vacuum-sealed bags.

    Product
    Onion Yellow Med 3 Outer Rings 4-5 LB in a 5 LB ,vacuum sealed, clear plastic bag. Labeling: White paper label with the following information attached to the outside of plastic bag. Blake's (Richmond) Onion Yellow Med 3 Outer Rings 4-5 LB PO# 047981 Lot#787806-6883R5, 795046-3948
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1506-2024·2024-04-17

    Chromophare Surgical Light System recalled for insufficient mounting force

    Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.

    Product
    Chromophare Surgical Light System , REF CH00000001
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1508-2024·2024-04-17

    Nucleic Acid Isolation Device Recall: EZ2 Connect MDx-IVD Heater Failure

    Qiagen Sciences is recalling 168 units of the EZ2 Connect MDx-IVD nucleic acid isolation device due to insufficient welding that causes heater cable embrittlement and device malfunction, resulting in sample loss during testing.

    Product
    EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2024·2024-04-17

    PEG feeding tube with blocked connector may impede placement procedure

    Boston Scientific's EndoVive 20Fr PEG Kit may have a blocked connector that prevents the guidewire from advancing during placement, potentially causing complications including bleeding and aspiration.

    Product
    EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1132-2024·2024-04-17

    Egg Salad Sandwich Recalled for Undeclared Fish Allergen Mislabeling

    Tuna salad sandwiches were mislabeled as egg salad, creating an undeclared fish allergen risk for consumers. The recall affects 551 units distributed to institutions and retailers across ten states.

    Product
    Egg salad sandwich packaged in clamshell for individual sale. 7.22oz (205g) UPC 766375938415
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1121-2024·2024-04-17

    Nicomex Tequesquite recalled due to elevated lead contamination

    Nicomex Inc. is recalling Nicomex Tequesquite seasoning (1.5 oz) due to elevated lead levels. Approximately 192 units were distributed to retailers in New Jersey and New York.

    Product
    Nicomex Tequesquite, Net Wt. 1.5oz (42.52gms), UPC: 8 8467810180 7. Packaged in a plastic bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1130-2024·2024-04-17

    Taylor Farms Buffalo Chicken Party Tray recalled for undeclared milk, wheat, soy

    Taylor Farms is recalling a Buffalo Chicken Party Tray because the product's bottom tray is mislabeled as a different salad, failing to declare the presence of milk, wheat, and soy. The recall affects 64 units distributed in Oregon and Washington.

    Product
    Taylor Farms Buffalo Chicken Party Tray, packaged in black plastic tray with clear plastic lid. This tray consists of 9 pieces of King's Hawaiian Bread. Net wt. 22.5oz (1.40lbs), UPC 30223 11582. Distributed by Taylor Farms NW Kent WA. The recalled product's plastic lid is cor
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1488-2024·2024-04-17

    Medline SwivAssist Bed Assist Bars Recalled for Safety Standard Non-Compliance

    Medline is recalling 79 Bed Assist Bars that failed to comply with federal safety standards for adult portable bed rails. The products were manufactured after the compliance deadline.

    Product
    Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
    Category
    Medical Device
    Distribution
    Distributed nationwide