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.

44001–44025 of 50511

  • HighFDA (Devices)·Z-0839-2013·2013-02-27

    Maquet ELS Cannula Recalled for Potential Arterial Lumen Occlusion

    Maquet is recalling ELS 15 FR Cannulas used for infant ECMO because they may contain an occluded arterial lumen.

    Product
    Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0841-2013·2013-02-27

    Elekta Monaco RTP System Recalled for Beam Angle Calculation Error

    Elekta is recalling 13 Monaco RTP Systems because the beam is displayed at the gantry angle, but the dose is calculated at the rotation_start angle.

    Product
    Monaco RTP System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2013·2013-02-27

    Greiner Bio-One Recalls VACUETTE Safety Blood Collection Sets

    Greiner Bio-One is recalling VACUETTE Safety Blood Collection Sets because a crack in the luer connector may cause small droplets of blood to leak during use.

    Product
    VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2013·2013-02-27

    International Technidyne Recalls Pro Time 3 Cuvettes for Inaccurate PT/INR Results

    International Technidyne Corp. is recalling specific lots of Pro Time 3 Cuvettes because they may produce lower than expected Prothrombin Time/INR results.

    Product
    Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2013·2013-02-27

    CareFusion Recalls SmartSite Gravity Blood Sets Due to Connection Separation

    CareFusion is recalling 5,050 units of SmartSite Gravity Blood Sets because the drip chamber and tubing may separate, potentially delaying treatment.

    Product
    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0842-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Packaging Integrity Issues

    Codman & Shurtleff is recalling 867 NeuroPath guiding catheters because packaging defects may compromise sterility. The devices were distributed worldwide.

    Product
    NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1003-2013·2013-02-27

    Publix Premium Bagels Recalled Due to Metal Fragments

    Bimbo Bakeries USA is recalling Publix Premium Bagels because metal fragments were found in two packages. Consumers should stop eating the product.

    Product
    Publix Premium Bagels, 20 oz packages; ORIGINAL, MULTI-GRAIN, and CINNAMON RAISIN SWIRL varieties.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0861-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 141 units of NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2013·2013-02-27

    ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Pouch Seals

    ConMed is recalling Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

    Product
    ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2013·2013-02-27

    Codman Neuropath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2013·2013-02-27

    Integra MAYFIELD Composite Base Units Recalled for Potential Breakage

    Integra LifeSciences is recalling 96 MAYFIELD Composite Series Base Units because they may break during use, posing a risk to patients during surgical procedures.

    Product
    MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical…
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0871-2013·2013-02-27

    Philips HeartStart XL+ Defibrillators Recalled for Potential Lockout

    Philips is recalling 3,785 HeartStart XL+ defibrillators because they may become locked out of clinical use.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2013·2013-02-27

    Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling 1,548 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2013·2013-02-27

    Merit Medical Systems Recalls Biliary Locking Drainage Catheters Due to Breakage

    Merit Medical Systems is recalling 387 Resolve Biliary Locking Drainage Catheters because a consumer reported the device broke into several pieces during use.

    Product
    Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·13V063000·2013-02-26

    US Specs Recalls Four Vehicles for Incorrect Passenger Mirror Labels

    US Specs is recalling four vehicles to correct incorrect font size labels on passenger side mirrors, which may hinder drivers' ability to judge object proximity.

    Product
    BMW — BMW, PORSCHE 750IL, 911 CARRERA, 635
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13126·2013-02-26

    Dynacraft Recalls Monster High City Motor Scooters Due to Fall Hazard

    Dynacraft is recalling about 5,500 Monster High City Motor Scooters sold at Walmart because they can accelerate suddenly, causing riders to lose control and fall.

    Product
    Motor Scooters with Monster High graphics
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13124·2013-02-26

    Ryobi Lithium 18 V 4Ah Battery Pack Recalled for Fire and Burn Hazards

    One World Technologies is recalling Ryobi Lithium 18 V 4Ah battery packs because they can overheat and burst while charging, posing fire and burn risks.

    Product
    Ryobi Lithium 18 V 4Ah Battery Pack
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V064000·2013-02-26

    Porsche 911 Carrera Recalled for Missing Seatbelt Locking Function

    US Specs is recalling one 2002 Porsche 911 Carrera because passenger seatbelts lack the required Automatic Locking Retractor function, posing a risk to child restraints.

    Product
    PORSCHE — PORSCHE 911 CARRERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V059000·2013-02-25

    Northwood Recalls 2013 Trailers Due to Incorrect Federal Identification Labels

    Northwood is recalling specific 2013 model year trailers because incorrect information on federal identification and weight labels could lead to improper loading and axle failure.

    Product
    SNOW RIVER — SNOW RIVER, ARTIC FOX, FOX MOUNTAIN 266RDS, 295K, 285RLS, 295T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V062000·2013-02-25

    Pierce Recalls 2007-2010 Velocity and Impel Fire Trucks for Door Defect

    Pierce Manufacturing is recalling 2007-2010 Velocity and Impel fire trucks because inner door handle springs may allow doors to open inadvertently while in motion.

    Product
    PIERCE — PIERCE IMPEL, VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V061000·2013-02-25

    Subaru Recalls Vehicles with Faulty Remote Engine Starter Fobs

    Subaru is recalling certain 2010-2013 vehicles equipped with Audiovox remote engine starter accessories because the fobs may malfunction and start the engine without user input.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY, IMPREZA, XV CROSSTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13122·2013-02-21

    Homelite Recalls Electric Blower Vacuums Due to Laceration Hazard

    Homelite is recalling electric blower vacuums sold at Home Depot because objects can break through the housing, posing a laceration hazard.

    Product
    Homelite Electric Blower Vacuums
    Category
    Consumer Product
    Distribution
    Distributed nationwide