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.

45401–45425 of 50512

  • HighFDA (Devices)·Z-1960-2012·2012-07-18

    GE Healthcare Recalls CT/PET Fusion Software Due to Image Alignment Issues

    GE Healthcare is recalling CT/PET Fusion software versions 4.0, 4.1, and 4.2 because fused CT and PET images may be incorrectly aligned.

    Product
    GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2012·2012-07-18

    GE Healthcare Recalls enFlow IV Fluid Warmer Straps for Biocompatibility Issues

    Vital Signs Devices is recalling enFlow Warmer Straps because they do not meet biocompatibility standards for skin contact.

    Product
    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2012·2012-07-18

    Abbott i-STAT1 Abaxis Analyzer Recalled for Overheating Battery Area

    Abbott Point of Care is recalling i-STAT1 Abaxis Analyzers because the battery area can become uncomfortably hot to touch.

    Product
    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2012·2012-07-18

    Encision Recalls AEM Disposable Electrodes Due to Unanticipated Alarms

    Encision, Inc. is recalling 48 boxes of AEM Disposable Electrodes after two complaints reported unanticipated alarms from the AEM monitor, which could cause delays or complications during surgery.

    Product
    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1986-2012·2012-07-18

    Philips HeartStart MRx Defibrillator Recalled for ECG Analysis Failure

    Philips is recalling 35 HeartStart MRx defibrillators because they cannot analyze ECG reports during 12-lead acquisition.

    Product
    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1970-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump malfunctions that could require backup equipment during surgery.

    Product
    System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2012·2012-07-18

    Atom Medical Infant Incubator Model 100 Recalled for Canopy Movement

    Atom Medical Corporation is recalling 377 Dual Incu i infant incubators because the canopy may move unintentionally during use.

    Product
    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1959-2012·2012-07-18

    Cardiovascular Systems Recalls Stealth 360-degree Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 27 Stealth 360-degree Orbital Atherectomy Devices due to a potential solder defect that could cause the crown to detach from the driveshaft.

    Product
    CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1757-2012·2012-07-18

    Inventure Foods Recalls Mozzarella Sticks and Onion Rings Due to Metal Particles

    Inventure Foods is recalling specific kits of mozzarella sticks and onion rings because they may contain tiny metal particles in the seasoning.

    Product
    Kit item #30699-76, includes Mozzarella Sticks, 2.25 oz, 12bags/kit; Cheddar Bacon Skins, 3oz, 24 bags/kit; and Sour Cream & Onion Skins 3oz, 12bags/kit. kit item#30679-11, 30679-12, and 30679-13, includes Mozzarella Sticks 2.25oz, 12bags/kit, Cheddar bacon skins 3oz, 24…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1756-2012·2012-07-18

    Inventure Foods Recalls Onion Rings and Mozzarella Sticks for Metal Particles

    Inventure Foods is recalling onion rings and mozzarella sticks due to potential tiny metal particles in the seasoning.

    Product
    Onion Rings, 2 oz, 3oz., 6.53 oz & 13 oz.. Burger King Brand, item#41016, 41105, 41121. T.G.I.F Brand, item#41130, 30587, 30587B, 30614, 30845A, 31124, 31125.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2012·2012-07-18

    Impac Medical MOSAIQ Oncology System Recall for Wedge Motor Unit Error

    Impac Medical is recalling MOSAIQ Oncology Information Systems due to a software error that incorrectly resets remaining Wedge Motor Units to zero after a machine fault.

    Product
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2007-2012·2012-07-18

    Elekta Monaco Software Recall for Incorrect Patient Shift Directions

    Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

    Product
    Monaco Product Usage: Planning of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12226·2012-07-18

    Panline USA Recalls Little Jumpers Trampolines Due to Fall Hazard

    Panline USA is recalling about 8,000 Alex Model 786X Little Jumpers Trampolines because the handlebar can break, creating a fall hazard.

    Product
    Alex ® Model 786X Little Jumpers Trampoline
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1753-2012·2012-07-18

    Sienna Bakery Cookies Recalled for Undeclared Walnut Allergen

    Best Maid Cookie Company is recalling Sienna Bakery cookies due to a potential mis-pack that may result in undeclared walnut allergens.

    Product
    Sienna Bakery¿ White Chocolate Macadamia Nut Gourmet Cookies, UPC 093901201706, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, CHOCOLATE FLAKES (SUGAR, COCOA, BUTTER, WHOLE MILK POWDER, SKIM MILK POWDER, MILK FAT, SOY…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1958-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Central Control Module Recall

    Terumo is recalling 648 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

    Product
    Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump occlusion malfunctions that could prevent pump use.

    Product
    System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 648 units of the Advanced Perfusion System 1 due to roller pump malfunctions that may require replacement with back-up equipment during procedures.

    Product
    System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2012·2012-07-18

    Arjo Sara Plus Patient Lifter Recalled for Exposed Metal Bracket Injury Risk

    ArjoHuntleigh is recalling Sara Plus Mobile Patient Lifters because removing the knee pad assembly exposes a metal support bracket, posing an injury risk.

    Product
    Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

    Terumo is recalling approximately 632 System 1 Base units because the backup battery depletes faster than expected, potentially causing unexpected system shutdowns.

    Product
    System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1982-2012·2012-07-18

    Stryker Definition PM Femoral Hip Stem Recalled for PMMA Coating Cracking

    Stryker Howmedica Osteonics is recalling 16,913 Definition PM Femoral Hip Stems due to potential cracking of the PMMA coating. The devices were distributed nationwide.

    Product
    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·12V332000·2012-07-16

    Kenworth T680 Recalled for Weak Upper Bunk Restraint Belts

    PACCAR is recalling 2013 Kenworth T680 trucks because the upper bunk restraint belts may be weaker than specified, increasing injury risk in crashes.

    Product
    KENWORTH — KENWORTH T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V331000·2012-07-16

    Volkswagen Recalls 2012 Beetles for Non-Compliant Summer Tires

    Volkswagen is recalling 2012 Beetles because some were equipped with summer tires that do not meet federal safety standards, potentially increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12224·2012-07-12

    Molenaar Recalls Folding Step Stools Due to Fall Hazard

    Molenaar LLC is recalling about 3,700 folding step stools because they can break or collapse unexpectedly, posing a fall hazard to consumers.

    Product
    Folding Step Stool
    Category
    Consumer Product
    Distribution
    Distributed nationwide