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.

44576–44600 of 50511

  • HighFDA (Devices)·Z-0132-2013·2012-10-31

    Biosense Webster MobiCath Bi-Directional Guiding Sheath Recalled for Catheter Interaction

    Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths due to a potential interaction with therapeutic catheters that may cause them to self-advance.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2013·2012-10-31

    Sorin Gish Straight Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish straight connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2013·2012-10-31

    GE Healthcare Recalls Discovery NM/CT 670 and NM 630 Systems

    GE Healthcare is recalling 210 Discovery NM/CT 670 and NM 630 systems due to a potential safety issue where the table pallet may contact the detector during operation.

    Product
    GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 26 units of the Sarns Modular Perfusion System 8000 due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 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…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Food)·F-0327-2013·2012-10-31

    General Mills Recalls Nature Valley Almond Granola Bars for Peanut Labeling Error

    General Mills is voluntarily recalling Nature Valley Sweet & Salty Nut Almond granola bars because they may contain peanuts not listed on the label.

    Product
    Individual wrapper: Nature Valley Sweet & Salty Nut, granola bars, Peanut, net WT 1.2 oz (35 g) UPC 0 1600044282 5, Distributed by General Mills Sales, INC., Minneapolis, MN 55440. Ingredients: Roasted Peanuts, High Maltose Corn Syrup......, Mixed Tocopherols Added to Retain…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0131-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 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…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0115-2013·2012-10-31

    GE Healthcare recalls innova mobile X-ray systems due to filter failure

    GE Healthcare is recalling 199 innova mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0139-2013·2012-10-31

    Encore Medical Recalls 6.5mm Cancellous Bone Screws Due to Labeling Errors

    Encore Medical is recalling 6.5mm Cancellous Bone Screws because some units were mislabeled with incorrect sizes, posing a risk of improper surgical fixation.

    Product
    6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Arterial Blood Gas (ABG) sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2013·2012-10-31

    GE Healthcare Recalls Seno Advantage 2.2 Workstations Due to Scale Factor Errors

    GE Healthcare is recalling 12 Seno Advantage 2.2 workstations because inaccurate scale factor annotations may lead to miscalculation of image sizes, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 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…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0116-2013·2012-10-31

    Advandx E. coli/P. aeruginosa PNA FISH Kit Recalled for Cross-Reactivity

    Advandx Inc is recalling 33 units of the E. coli/P. aeruginosa PNA FISH kit because Pseudomonas putida strains may cross-react, causing false-positive results.

    Product
    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 1,097 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 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…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0129-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 312 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0158-2013·2012-10-31

    Sorin Gish Reducer Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish Reducer Connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2013·2012-10-31

    GE Seno Advantage Workstation Recalled for Incorrect Magnification Measurements

    GE Healthcare is recalling Seno Advantage Workstations because measurement values may be incorrect for magnification images from non-GE digital mammography systems.

    Product
    GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2013·2012-10-31

    Elekta Recalls Oncentra External Beam 4.1 Radiation Treatment Planning Software

    Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 software due to a defect that allows beam weights to be changed during dose calculation without error messages.

    Product
    Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0516-2013·2012-10-31

    Kraft Jalapeno String Cheese Recalled for Potential Choking Hazard

    Kraft Foods is recalling Jalapeno String Cheese because plastic film may remain on the cheese, posing a choking risk.

    Product
    Kraft Jalapeno String Cheese, Net Wt 12 Oz (340 g); a natural low-moisture part-skim mozzarella cheese with jalapeno peppers; 12 individually wrapped 1 oz snacks per 12 oz. bag, 12 bags per case; Distributed by Kraft Foods Global, Inc., Northfield, IL 60093-2753 USA; UPC 0 21000…
    Category
    Food
    Distribution
    23 states
  • HighNHTSA·12V525000·2012-10-31

    General Motors Recalls 2013 Cadillac XTS for Head Restraint Defect

    General Motors is recalling 2013 Cadillac XTS vehicles because rear head restraints may fail to lock upright, increasing neck injury risk in crashes.

    Product
    CADILLAC — CADILLAC XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling ABG sampling kits containing TRIAD alcohol pads due to potential contaminants in the pads.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2013·2012-10-31

    GE Healthcare Recalls innova 3100 Mobile X-ray Systems Due to Filter Failure

    GE Healthcare is recalling 199 innova 3100 mobile X-ray systems due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also…
    Category
    Medical Device
    Distribution
    Distributed nationwide