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.

43776–43800 of 50511

  • HighFDA (Devices)·Z-1031-2013·2013-04-10

    Medtronic Recalls Prostiva RF Therapy Generators Due to Static Electricity Risk

    Medtronic is recalling 848 Prostiva RF Therapy Generators because static electricity may unintentionally start or stop the treatment process if the footswitch is not connected.

    Product
    Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2013·2013-04-10

    Beckman Coulter Recalls UniCel DxC 600i Synchron Access Clinical Systems

    Beckman Coulter is recalling 956 UniCel DxC 600i Synchron Access Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2013·2013-04-10

    Beckman Coulter Synchron LXi 725 Clinical System Recalled for Defective Pulley

    Beckman Coulter is recalling 83 Synchron LXi 725 Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V123000·2013-04-09

    Toyota Recalls Vehicles with Inaccurate Weight Labels

    Southeast Toyota is recalling specific 2008-2013 models because weight labels were inaccurate, potentially leading to vehicle overloading and tire failure.

    Product
    TOYOTA — TOYOTA, SCION CAMRY, HIGHLANDER, PRIUS, TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V127000·2013-04-09

    Freightliner Recalls 2012-2014 Trucks for Missing Parking Brake Warning

    Daimler Trucks North America is recalling 2012-2014 Freightliner Cascadia and Coronado trucks because the dashboard may fail to display a warning when the parking brake is not applied.

    Product
    FREIGHTLINER — FREIGHTLINER CORONADO, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13163·2013-04-09

    Home Depot Recalls CE Tech Riser Cable Due to Fire Hazard

    Home Depot is recalling CE Tech 1,000 ft. Riser Cables because they do not meet fire resistance standards, posing a fire hazard.

    Product
    CE Tech 1,000 ft. Riser Cable
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13164·2013-04-09

    Manchester Tank Recalls 100-Pound Propane Cylinders Due to Fire Hazard

    Manchester Tank & Equipment Company is recalling about 7,500 100-pound propane cylinders because fuel may leak from the thread connection, posing a fire hazard.

    Product
    100-pound Propane Cylinders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13162·2013-04-04

    Dynacraft Recalls Urban Shredder Ride-On Toys Due to Fall Hazard

    Dynacraft is recalling Urban Shredder ride-on toys because they can unexpectedly accelerate, posing a fall hazard. No injuries have been reported.

    Product
    Urban Shredder Ride-On Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V118000·2013-04-03

    Chrysler Recalls 2011-2012 Models for Seat Airbag Wiring Defect

    Chrysler is recalling 2011-2012 Chrysler 300, Dodge Challenger, and Charger vehicles because seat airbag wiring may malfunction, increasing injury risk in crashes.

    Product
    CHRYSLER — CHRYSLER, DODGE 300, CHARGER, CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2013·2013-04-03

    Siemens Axiom Artis zeego Angiographic X-Ray System Recall

    Siemens is recalling 52 Axiom Artis zeego systems due to a potential risk to patients or operators during operation.

    Product
    Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1140-2013·2013-04-03

    Riggio Dist Co Recalls Glory Foods Mixed Greens Due to Listeria Risk

    Riggio Dist Co is recalling 2,200 bags of Glory Foods Mixed Greens in Illinois and Michigan after routine testing detected Listeria monocytogenes.

    Product
    Glory Foods Mixed Greens, Verduras Mixtas 16 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0983-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall covers units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2013·2013-04-03

    Cardinal Health Recalls Needle Counters Due to Packaging Defects

    Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2013·2013-04-03

    Advanced Sterilization Products Recalls STERRAD 200 System Carriage Units

    Advanced Sterilization Products is recalling STERRAD 200 System Carriages because they may become dislodged under excessive load.

    Product
    STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2013·2013-04-03

    Biomerieux VITEK 2 Compact Computer System Recall for Patient Data Error

    Biomerieux Inc. is recalling VITEK 2 Compact computer systems because a software issue could link test results to the wrong patient.

    Product
    VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc7700 8-port, Cat. #W0447; (4) dc7700 8-port (refurbished), Cat. #W0447R; (5) dc7800, Cat.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2013·2013-04-03

    Medtronic Archer Super Stiff Guidewire Recalled for Coating Separation Risk

    Medtronic is recalling Archer Super Stiff Guidewires because the PTFE coating may separate from the wire during use.

    Product
    Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0990-2013·2013-04-03

    Biomerieux VITEK 2 XL Computer System Recalled for Patient Data Linking Errors

    Biomerieux Inc. is recalling VITEK 2 XL computer systems equipped with specific Hewlett-Packard PCs due to a potential risk of linking test results to the wrong patient.

    Product
    VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2013·2013-04-03

    Smiths Medical Medfusion Syringe Pumps Recalled for Seal Migration Risk

    Smiths Medical is recalling six Medfusion Model 3500 syringe pumps in New Hampshire because a seal defect could cause the plunger rod seal to migrate during specific infusion conditions.

    Product
    Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·13E016000·2013-04-03

    Sika Recalls Automotive Glass Adhesives Due to Curing Defects

    Sika is recalling SikaTITAN P2G automotive glass bonding adhesives because they may not harden properly, risking glass displacement and injury.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2013·2013-04-03

    Medtronic Archer Super Stiff Guidewires Recalled for Potential Kinking and Breaking

    Medtronic is recalling specific Archer Super Stiff Guidewires due to a manufacturing defect that may cause the device to kink or break during use.

    Product
    Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange…
    Category
    Medical Device
    Distribution
    Distributed nationwide