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.

11176–11200 of 22147

  • HighFDA (Devices)·Z-2025-2024·2024-06-12

    Bedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms

    Nihon Kohden's BSM-3000 Series Bedside Monitors may produce false SpO2 probe failure alarms due to a software issue. Healthcare facilities should contact the manufacturer for guidance.

    Product
    BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2024·2024-06-12

    ADVANTA VXT vascular graft recalled for slider rod separation

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to complaints of separation between the slider rod and swivel core, which could affect proper device function.

    Product
    ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2024·2024-06-12

    Medical device recall: HA FlexTrak patient transport trolley oil leak hazard

    Philips is recalling the HA FlexTrak patient transport trolley due to potential oil leaks from the hydraulic system that create slipping and falling hazards. Approximately 100 units have been distributed worldwide.

    Product
    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2024·2024-06-12

    Synchro2 Guidewires: PTFE coating damage from improper backloading technique

    Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.

    Product
    The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2024·2024-06-12

    FLIXENE Vascular Graft Slider Rod Separation Defect Recall

    Atrium Medical Corporation has recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the pieces.

    Product
    FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2024·2024-06-12

    Proton Therapy System May Continue Irradiation When Accelerator Control Parameters Out of Tolerance

    Ion Beam Applications' IBA Proton Therapy System PROTEUS 235 may continue delivering radiation when critical accelerator control parameters are outside defined tolerances. Affected users should contact the manufacturer regarding firmware updates.

    Product
    IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2024·2024-06-12

    Synchro SELECT Guidewires may have PTFE coating damage

    Stryker Neurovascular recalls certain lots of Synchro SELECT Guidewires due to PTFE coating damage that may occur when using a backloading technique. The damage is caused by sharper-than-intended edges on older introducer versions.

    Product
    The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guidewires are compatible with existing microcatheters used in common procedures s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2024·2024-06-12

    Vascular Graft Slider Component May Separate from Core

    Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide after reports of the slider swivel rod separating from the swivel core with a notable gap between components.

    Product
    ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2024·2024-06-12

    Prescription migraine drug recalled for manufacturing impurity above FDA limit

    Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1302-2024·2024-06-12

    Panera Kitchen Sink Cookie Recalled Due to Potential Salmonella Contamination

    Panera Kitchen Sink Cookie dough pucks from Rise Baking Company are being recalled due to potential Salmonella contamination. The recall covers 29,019 cases distributed across 20 U.S. states.

    Product
    Panera Kitchen Sink Cookie, Net Wt. 45 lb (20.41 kg), 120/6 oz dough pucks/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2006-2024·2024-06-12

    Vascular graft component separation reported in FLIXENE Slider GDS devices

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation between the Slider GDS Swivel Rod and Swivel Core, affecting 53,308 units distributed worldwide.

    Product
    FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2024·2024-06-12

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs may give inaccurate readings

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs may provide inaccurate measurements. The FDA recalls approximately 23,180 boxes distributed across 20 US states.

    Product
    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2024·2024-06-12

    Hysteroscope recalled due to missed required leakage test

    Olympus OES 4000 Hysteroscope Model A4674A is being recalled because a required leakage test was not performed after device repairs. Liquid could enter the eyepiece, causing a foggy image during use.

    Product
    OES 4000 Hysteroscope, Model/Catalog Number: A4674A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2024·2024-06-12

    Medline Sterile Iris Scissors Recall Due to Detachable Tip Protector

    Medline is recalling 67,811 units of sterile iris scissors because the tip protector may detach during use. The recall affects units distributed nationwide and internationally.

    Product
    MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2024·2024-06-12

    Vascular Graft Component Separation in ADVANTA VXT Medical Devices

    ADVANTA VXT vascular grafts are being recalled because the Slider GDS Swivel Rod may separate from the Swivel Core. This affects about 53,308 units distributed worldwide including the US.

    Product
    ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1946-2024·2024-06-12

    Newport Laser Systems Recalled for Removable Safety Key Defect

    Newport has recalled Class II laser systems because their key-actuated safety switch can be removed while the laser remains on, violating federal safety requirements.

    Product
    Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0532-2024·2024-06-12

    Prescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity

    Glenmark Pharmaceuticals recalls Rizatriptan Benzoate 5mg tablets due to excess N-Nitroso Desmethyl Rizatriptan impurity. The nationwide recall affects 3,480 cartons with lots 19233788 and 19224445.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2024·2024-06-12

    Vascular graft recalled for separation of slider mechanism

    Atrium Medical Corporation recalls FLIXENE vascular grafts due to separation of the slider swivel rod from the core assembly. The device defect affects 53,308 units distributed worldwide.

    Product
    FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1375-2024·2024-06-12

    Tortilla de Harina Recalled for Undeclared Wheat Allergen

    El Mirasol, Inc. is recalling Tortilla de Harina flour tortillas in Florida due to undeclared wheat allergen. Consumers with wheat allergies should not consume this product.

    Product
    Tortilla de Harina, 400 gr, 10 count, packaged in clear plastic bag, 20 packages per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1944-2024·2024-06-12

    Alaris Pump Infusion Set Drip Chamber May Detach During Use

    A defective drip chamber in the Alaris Pump Infusion Set may detach from the tubing, potentially delaying treatment or causing unintended exposure to medications. BD is recalling approximately 11,300 units distributed across the US and Canada.

    Product
    Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2024·2024-06-12

    Vascular graft slider component may separate from core

    Atrium Medical's ADVANTA VXT vascular graft may experience separation of the slider mechanism from its core, affecting over 11,000 US units. No injuries have been reported.

    Product
    ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2024·2024-06-12

    ADVANTA VXT vascular graft slider component separation recall

    ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2024·2024-06-12

    Vascular Graft Recalled Due to Swivel Rod Separation Risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide due to complaints of the swivel rod separating from the core, which could compromise device function during medical procedures.

    Product
    ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2024·2024-06-12

    Vascular graft separation risk affects FLIXENE slider GDS devices

    Atrium Medical recalls FLIXENE vascular grafts due to complaints of slider rod separation from the swivel core, which could affect device function.

    Product
    FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2024·2024-06-12

    Medline Syringes Recalled Due to Leaks, Breakage, and Quality Issues

    Medline Industries is recalling over 2.3 million syringes due to identified leaks, breakage, and quality issues that may pose risks to patient health. The affected syringes were distributed nationwide and internationally.

    Product
    Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide