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.

44326–44350 of 50511

  • HighCPSC·13074·2012-12-18

    Norco Recalls 2011 Havoc Bicycles Due to Frame Crack Risk

    Norco is recalling 2011 Havoc 24-inch and 26-inch bicycles because the frame can crack at the top and down tube joint, posing a risk of injury or death.

    Product
    2011 Havoc Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13072·2012-12-18

    Catalina Outdoor Fireplaces Recalled for Burn and Laceration Hazards

    Christmas Tree Shops is recalling Catalina Outdoor Fireplaces because the glass components can break when a fire is lit, posing a burn and laceration hazard.

    Product
    Catalina Outdoor Fireplaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13067·2012-12-13

    Enesco Recalls Shelly's Diner Collectible Due to Fire Hazard

    Enesco is recalling Shelly's Diner collectibles because the power adapter can overheat and melt, posing a fire hazard. No injuries or property damage have been reported.

    Product
    Shelly's Diner® Collectible Ceramic
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13069·2012-12-13

    Easy-Rest Classic Mattresses Recalled for Fire Hazard

    Easy-Rest is recalling about 3,800 Classic 5 Foam Core mattresses because they fail to meet federal flammability standards, posing a fire hazard.

    Product
    Classic by Easy-Rest Classic 5 Foam Core Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0758-2013·2012-12-12

    Zingerman's Bakehouse Cookies Recalled for Missing Allergen Labeling

    Zingerman's Bakehouse is recalling Junior Triple Trouble Chocolate Cookies because the labels failed to identify milk and wheat as ingredients.

    Product
    Zingerman's Bakehouse Junior Triple Trouble Chocolate Cookies Net wt. 6 ounces
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0471-2013·2012-12-12

    Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk

    Biomet is recalling 46 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.

    Product
    OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0462-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.

    Product
    24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0458-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip could detach and harm patients during surgery.

    Product
    24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0464-2013·2012-12-12

    Merit Medical Systems Recalls Custom Procedural Trays Due to Missing Tape

    Merit Medical Systems is recalling 83 custom procedural trays because clear protective tape was not applied during manufacturing.

    Product
    Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2013·2012-12-12

    Philips Digital Diagnost Software Recall for Image Marker Error

    Philips is recalling Digital Diagnost Software R2.0.2 because a mirrored image marker can be mistaken for a patient side indicator.

    Product
    Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2013·2012-12-12

    Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Defect

    Biomet is recalling 36 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.

    Product
    OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Medical Device
    Distribution
    Distributed nationwide