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.

43601–43625 of 50511

  • HighFDA (Devices)·Z-1285-2013·2013-05-22

    Integra Recalls DuraGen XS Dural Regeneration Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling 52 boxes of DuraGen XS Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2013·2013-05-22

    Integra OraTape Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling OraTape Absorbable Collagen Wound Dressings because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1381-2013·2013-05-22

    Early Bird Foods Recalls Granola Snack Mix for Undeclared Soya Lecithin

    Early Bird Foods & Co. is recalling CHOC-A-DOODLE-DOO granola snack mix due to undeclared soya lecithin. The product was distributed in six states.

    Product
    Early Bird Foods & Co. CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix, Net Wt. 12 oz packaged in clear plastic bag. Each case contains 12 packages. UPC: 6 89466 30000 0.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1327-2013·2013-05-22

    Hologic Fluoroscan Mini C-arm InSight2 Recalled for Inaccurate Irradiation Time Alarms

    Hologic is recalling Fluoroscan Mini C-arm InSight2 systems because the audible alarm and total cumulative irradiation time displays are inaccurate.

    Product
    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2013·2013-05-22

    Integra Ora Plug Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling Ora Plug Absorbable Collagen Wound Dressings due to potential pyrogen levels exceeding specifications.

    Product
    Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2013·2013-05-22

    Becton Dickinson Recalls Trypticase Soy Agar Media Due to Bacterial Contamination

    Becton Dickinson is recalling Trypticase Soy Agar media because it may be contaminated with bacteria. The recall covers 521,160 pieces distributed worldwide.

    Product
    BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1403-2013·2013-05-22

    Grippo's Potato Chips Recalled for Metal Fragments in Salt Hopper

    Grippo's Cheddar Cheese with a Touch of Jalapeno Potato Chips are being recalled due to metal fragments found in the salt hopper during an inspection.

    Product
    Grippo's CHEDDAR CHEESE WITH A TOUCH OF JALAPENO natural & Artificially Flavored POTATO CHIPS, 1¿¿oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, GRANULAR CHEESE (MILK, CHEESE CULTURES, SALT ENZYMES), MONOSODIUM GLUTAMATE, PARTIALLY HYDROGENATED SOYBEAN AND…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1292-2013·2013-05-22

    CollaCote Absorbable Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling CollaCote Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2013·2013-05-22

    Karl Storz Cutting Loops Recalled for Potential Sterile Packaging Damage

    Karl Storz is recalling specific cutting loops due to possible damage to sterile packaging, which may result in airborne contamination.

    Product
    Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2013·2013-05-22

    Varian High Energy Clinacs Radiation Treatment System Recall for Beam Symmetry

    Varian is recalling High Energy Clinacs because photon beams may develop asymmetry, potentially causing minor patient injury or decreased disease control.

    Product
    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2013·2013-05-22

    GE Healthcare Recalls Innova Fluoroscopic Systems Due to Relay Failure

    GE Healthcare is recalling 713 Innova fluoroscopic systems because a relay failure in the power distribution box can cause sudden loss of imaging modes without warning.

    Product
    GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2013·2013-05-22

    Hologic Fluoroscan Mini C-arm InSight Recalled for Inaccurate Irradiation Time Alarms

    Hologic is recalling Fluoroscan Mini C-arm InSight systems because the audible alarm for cumulative irradiation time is inaccurate. This may result in incorrect total irradiation time readings.

    Product
    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2013·2013-05-22

    Integra Recalls Helistat Absorbable Hemostatic Due to Pyrogen Levels

    Integra LifeSciences is recalling 24,342 boxes of Helistat Absorbable Hemostatic because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2013·2013-05-22

    Integra HeliTape Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling HeliTape Absorbable Collagen Wound Dressings for dental surgery due to potential pyrogen levels exceeding specifications.

    Product
    HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1401-2013·2013-05-22

    Grippo's Salt & Vinegar Potato Chips Recalled for Metal Fragments

    Grippo Potato Chip Co. is recalling Salt & Vinegar flavored potato chips due to metal fragments found in the salt hopper during an inspection.

    Product
    Grippo's Salt & Vinegar FLAVORED POTATO CHIPS, 1¿oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, LACTOSE, SALT, DEXTROSE, SODIUM DIACETATE, MALIC ACID, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED CONTAINS: MILK***www.grippopotatochips.com GRIPPO POTATO CHIP…
    Category
    Food
    Distribution
    6 states
  • HighCPSC·13734·2013-05-21

    Kubota Recalls ZG100 Series Riding Mowers Due to Fire Hazard

    Kubota is recalling about 8,600 ZG100 Series Zero Turn riding mowers because a fuel tank defect can cause leaks and fire. No injuries or property damage have been reported.

    Product
    Kubota ZG100 Series Zero Turn riding mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V215000·2013-05-21

    Triumph Recalls 2012 Motorcycles Due to Missing Throttle Cable Guide

    Triumph is recalling 2012 Daytona 675 and Street Triple motorcycles because missing throttle cable guides may impede steering and increase crash risk.

    Product
    TRIUMPH — TRIUMPH DAYTONA 675, STREET TRIPLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V212000·2013-05-21

    Triumph Recalls 2012-2013 Motorcycles Due to Transmission Defect

    Triumph is recalling 2012-2013 Speed Triple ABS motorcycles because an incorrect transmission spring may cause the bike to shift out of gear, increasing crash risk.

    Product
    TRIUMPH — TRIUMPH TIGER 1050, SPRINT GT, TIGER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V203000·2013-05-17

    Forest River Recalls 2013-2014 RVs for Power Awning Motor Defect

    Forest River is recalling 2013-2014 recreational vehicles because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER, PALOMINO, CARGO MATE WILDWOOD, WORK AND PLAY, XLR, MAVERICK TRUCK CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide