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.

43351–43375 of 50511

  • HighFDA (Devices)·Z-1607-2013·2013-07-03

    Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction

    Medtronic is recalling specific Consulta and Syncra CRT-P pacemakers manufactured in April and May 2013 due to a production issue that could cause malfunction. No device failures have been reported.

    Product
    Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1602-2013·2013-07-03

    Baxter Recalls Regional Analgesia Infusor Systems Due to Rupture Complaints

    Baxter Healthcare is recalling Regional Analgesia Infusor Systems with Patient Control due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.

    Product
    Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1563-2013·2013-07-03

    Sara Lee Bakery Buns Recalled for Possible Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee Hearty & Delicious 100% Whole Wheat Bakery Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Sara Lee Hearty & Delicious 100% Whole Wheat 8 Bakery Buns Sara lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1601-2013·2013-07-03

    Baxter Recalls Multirate Infusor Devices Due to Rupture Complaints

    Baxter Healthcare is recalling 3,255,096 Multirate Infusor Devices due to an increase in rupture complaints. The devices are indicated for the intravenous administration of medications.

    Product
    Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2013·2013-07-03

    Prism Medical C-Series Carry Bar Recalled for Improper Installation

    Prism Medical Services USA is recalling 1,131 C-Series Carry Bars due to improper installation. The firm is replacing them with a plastic insert and metal insert carry bar.

    Product
    Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2013·2013-07-03

    Baxter Recalls SV Elastomeric Infusion Devices Due to Rupture Complaints

    Baxter Healthcare is recalling SV Elastomeric Infusion Devices due to an increase in rupture complaints. The devices are used for intravenous medication administration.

    Product
    Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2013·2013-07-03

    Baxter Recalls Infusor SV and LV Elastomeric Infusion Devices Due to Rupture Complaints

    Baxter Healthcare is recalling Infusor SV and LV Elastomeric Infusion Devices due to an increase in rupture complaints. The recall aims to ensure no affected product remains in the field.

    Product
    Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2013·2013-07-03

    Roche Recalls CoaguChek XS Meters Due to Potential INR Test Errors

    Roche is recalling CoaguChek XS meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13235·2013-07-03

    H-E-B Recalls Outdoor Solutions Hammock with Sunshade Due to Fall Hazard

    H-E-B is recalling Outdoor Solutions Hammocks with Sunshades because the seam can tear, posing a fall hazard. Consumers should stop using the product and contact H-E-B for a refund.

    Product
    Outdoor Solutions Hammock with Sunshade
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling 400 units of INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2013·2013-07-03

    Roche Recalls CoaguChek XS Meters Due to Potential Test Errors

    Roche is recalling CoaguChek XS System meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1571-2013·2013-07-03

    BIMBO Bakeries Recalls Earthgrains Hamburger Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling 741 cases of Earthgrains Foodservice Hamburger Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Foodservice Hamburger Buns - 20 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
    Category
    Food
    Distribution
    4 states
  • HighCPSC·13741·2013-07-02

    Yamaha Recalls Big Bear 400 ATVs Due to Front Shock Failure

    Yamaha is recalling about 100 Big Bear 400 ATVs because the front shock absorber can break, causing a crash hazard. No injuries have been reported.

    Product
    Yamaha All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V290000·2013-07-02

    Farber Recalls 2012 Ford 550 Command Center Vehicles for Awning Motor Defect

    Farber Specialty Vehicles is recalling 2012 Ford 550 Command Center vehicles because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    FARBER SPECIALTY — FARBER SPECIALTY FORD 550 COMMAND CENTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V286000·2013-07-02

    Kibbi Recalls 2013 Renegade Trailer Due to Awning Motor Defect

    Kibbi is recalling one 2013 Renegade KIT28TA trailer because a design change may cause awning motor screws to shear, potentially allowing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    RENEGADE — RENEGADE KIT28TA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V283000·2013-07-02

    Chrysler Recalls 2013 Minivans and Vans Due to Airbag Software Error

    Chrysler is recalling 2013 Town & Country, Grand Caravan, and C/V Tradesman vehicles because a software error may cause the wrong side airbags to deploy in a crash.

    Product
    CHRYSLER — CHRYSLER, DODGE, RAM TOWN AND COUNTRY, GRAND CARAVAN, C/V TRADESMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V285000·2013-07-01

    Augusta RV Recalls 2013-2014 FLEX Trailers Due to Awning Motor Defect

    Augusta RV is recalling 36 model year 2013-2014 FLEX recreational trailers because a design change in the power awning motor assembly may cause screws to shear, potentially allowing the awning to unfurl unexpectedly.

    Product
    AUGUSTA — AUGUSTA FLEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V280000·2013-06-28

    LDV Recalls 2012-2013 Mobile Specialty Vehicles Due to Awning Motor Defect

    LDV, Inc. is recalling 2012-2013 mobile specialty vehicles because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    LDV — LDV MOBILE SPECIALTY VEHICLE
    Category
    Vehicle
    Distribution
    Distributed nationwide