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.

40001–40025 of 50506

  • HighFDA (Devices)·Z-0464-2015·2014-12-03

    Vision RT AlignRT System Recalled for Potential Interlock Failure

    Vision RT is recalling AlignRT systems due to a potential failure to assert interlock, which could affect radiation safety during treatment.

    Product
    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0285-2015·2014-12-03

    Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Hospira is recalling 16.5 million bags of 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices

    Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.

    Product
    8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0419-2015·2014-12-03

    Gyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise

    Gyrus Acmi is recalling Falope-Ring Band Applicator Kits due to sterile packaging compromises that could lead to bacterial contamination and patient infection.

    Product
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0568-2015·2014-12-03

    Los Chileros Recalls Multiple Products Due to Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling seven food products, including cornbread and mixes, because they contain undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Blue Cornbread, 9.84 oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0567-2015·2014-12-03

    Los Chileros Recalls Seven Products Due to Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling seven food products, including Santa Fe Chile Seasoning, due to undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Santa Fe Chile Seasoning, 4.5oz (127.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2015·2014-12-03

    Intuitive Surgical Recalls 8mm ProGrasp Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0439-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Tenaculum Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Tenaculum Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0442-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighNHTSA·14V769000·2014-12-03

    Nova Bus Recalls 2012 LFS Transit Buses Due to Seat Anchor Defect

    Nova Bus is recalling 2012 LFS transit buses because a seat anchor rivnut may not secure the seat properly, increasing injury risk if the seat detaches.

    Product
    NOVA BUS — NOVA BUS NOVA LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues

    Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0446-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm clip appliers because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0473-2015·2014-12-03

    Philips IntelliSpace Portal Software Defect May Display Incorrect Cardiac Measurements

    Philips is recalling 32 IntelliSpace Portal systems due to a software defect that may display incorrect cardiac and aortic anatomy measurements used for sizing Transcatheter heart valves.

    Product
    IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0571-2015·2014-12-03

    Los Chileros Recalls Multiple Products Due to Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling seven food products, including Green Chile Stew with Tortilla Mix, because they contain undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Stew with Tortilla Mix, 13oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0577-2015·2014-12-03

    Kerry Foods Recalls Meatball Seasoning Due to Salmonella Risk

    Kerry Foods is recalling two meatball seasoning products because they were processed on equipment used for a product that tested positive for Salmonella.

    Product
    Kerry 52-0189-02 All Purpose Beef & Chicken Meatball Seasoning, Net WT 43.42 lbs (19.69 Kg) , B18517.01.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0421-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira Inc. is recalling GemStar infusion pumps because patients are using publicly available codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Monopolar Curved Scissors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Monopolar Curved Scissors because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0566-2015·2014-12-03

    Los Chileros Sopaipilla Mix Recalled for Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling Sopaipilla Mix and other products due to undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Sopaipilla Mix, Net Wt. 12 oz (340 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·15710·2014-12-02

    Eaton Recalls Electrical Meter Breakers Due to Shock Hazard

    Eaton is recalling about 1,100 MBED 3042 series residential meter breakers because their electrical components can be easily accessed, posing a shock hazard.

    Product
    Electrical Meter Breakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide