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.

40526–40550 of 50511

  • HighFDA (Devices)·Z-2588-2014·2014-09-10

    Galt Medical Recalls Valved Tearaway Introducer Sets Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Introducer Sets because the adhesive may dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V552000·2014-09-10

    Mazda Recalls 2008 Tribute Hybrids for Coolant Pump Failure Risk

    Mazda is recalling 2008 Tribute Hybrid vehicles because a coolant pump failure may cause the hybrid system to overheat and shut down, increasing crash risk.

    Product
    MAZDA — MAZDA TRIBUTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2014·2014-09-10

    Ellex iScience Recalls iTRACK250A Canaloplasty Microcatheter Kits

    Ellex iScience is recalling 148 iTRACK250A Canaloplasty Microcatheter Kits because one lot may not have been properly sealed, resulting in non-sterile devices.

    Product
    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V550000·2014-09-10

    Yamaha Recalls 2014 FZ09 Motorcycles Due to Headlight Harness Defect

    Yamaha is recalling 5,300 model year 2014 FZ09 motorcycles because a short headlight harness may break when handlebars are turned, causing the headlight to go out.

    Product
    YAMAHA — YAMAHA FZ-09
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2014·2014-09-10

    Galt Medical Recalls Valved Tearaway Kits Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Kits because the adhesive could dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2014·2014-09-10

    Bio-Detek Recalls Medsolutions4U Multi-Function Electrodes Due to Connector Defect

    Bio-Detek, Inc. is recalling Medsolutions4U Multi-Function Electrodes because an incorrect wire connector prevents them from interfacing with PhysioControl Lifepak Defibrillators.

    Product
    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2577-2014·2014-09-10

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 CD Top; Left Size 3-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2014·2014-09-10

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2014·2014-09-10

    Roche cobas IT 1000 Recalled for Potential Patient ID Mismatch

    Roche Diagnostics is recalling 148 cobas IT 1000 devices because they may assign test results to the wrong patient ID if specific system messages are received.

    Product
    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14752·2014-09-10

    Honda Recalls Gas-Powered Generators Due to Frame Support Failure Risk

    American Honda is recalling 2014 EU7000isN AT generators because the rear frame support can fail during lifting, posing an impact hazard. The owner's manual may also contain errors.

    Product
    Gas-powered generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14272·2014-09-10

    Benetton Recalls Boys' Jackets Due to Waist Drawstring Entanglement Hazard

    Benetton is recalling approximately 93 boys' hooded jackets because the waist drawstring poses an entanglement hazard. Consumers should remove the drawstring or contact the company for a refund.

    Product
    Boy's hooded jacket with a waist drawstring
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisionals Recalled for Breakage

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1576-2014·2014-09-10

    Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

    Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets 25 mg because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAROXETINE HYDROCHLORIDE — PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2583-2014·2014-09-10

    Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings after receiving a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

    Product
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2560-2014·2014-09-10

    OrthoPediatrics ACL Sleeve Installation Tool Recalled for Weld Fractures

    OrthoPediatrics Corp is recalling 56 ACL Sleeve Installation Tools due to weld fractures. The tools are used in pediatric and small stature adult ACL reconstruction systems.

    Product
    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2014·2014-09-10

    Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors

    Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.

    Product
    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14271·2014-09-09

    Cabrinha Recalls Kiteboarding Control Systems Due to Spring Jamming Risk

    Cabrinha is recalling 1X and Overdrive 1X kiteboarding control systems because the Recoil spring can jam, causing loss of control and injury risk.

    Product
    Cabrinha Kiteboarding 1X and Overdrive 1X Control Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V537000·2014-09-05

    Harley-Davidson Recalls 2014 Motorcycles Due to Clutch Master Cylinder Defect

    Harley-Davidson is recalling 105,746 model year 2014 motorcycles because a clutch master cylinder component may fail, causing the bike to creep forward.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXSBSE, FLHTCUTG, FLHX, FLHRSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V529000·2014-09-04

    Chrysler Recalls 2013-2014 SRT Viper for Air Bag Deployment Defect

    Chrysler is recalling 2013-2014 SRT Vipers because inaccurate seat sensors may cause air bags to deploy at lower-than-designed velocities, increasing injury risk.

    Product
    SRT — SRT VIPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14269·2014-09-04

    Livie and Luca Recalls Children's Shoes Due to Laceration Hazard

    Livie and Luca is recalling Carta and Cotton children's shoes because a metal thread inside the liner can poke through and cut a child's foot.

    Product
    Carta and "Cotton" Children's Shoes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14270·2014-09-04

    JVC 42-Inch Flat Panel Televisions Recalled for Tip-Over Risk

    AmTRAN Video is recalling JVC 42-inch flat panel televisions because the stand neck can crack, causing the TV to tip over and pose an impact injury risk.

    Product
    JVC 42-inch flat panel televisions
    Category
    Consumer Product
    Distribution
    Distributed nationwide