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.

45276–45300 of 50512

  • HighFDA (Devices)·Z-2130-2012·2012-08-08

    ICU Medical Recalls 94-inch IV Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of 94-inch IV administration sets because a molding defect may cause side ports to become occluded.

    Product
    94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1828-2012·2012-08-08

    Spillson's Club Sub Sandwich Recalled for Undeclared Wheat Allergen

    Spillson's Ltd. is recalling Club Sub Sandwiches because they contain undeclared wheat. People with wheat allergies or sensitivities are at risk of serious or life-threatening reactions.

    Product
    Spillson's Ltd. Club Sub Sandwich, 7oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2105-2012·2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2012·2012-08-08

    Arm and Hammer Spinbrush Toothbrush Recalled for Choking Hazard

    Church & Dwight is recalling 22.783 million Arm and Hammer Spinbrush toothbrushes worldwide due to a potential choking hazard from small parts.

    Product
    Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Food)·F-1815-2012·2012-08-08

    Dr. Mercola Miracle Whey Protein Powder Recalled for Undeclared Soy Lecithin

    Defense Nutrition is recalling Dr. Mercola Miracle Whey Protein Powder because it contains undeclared soy lecithin, a potential allergen.

    Product
    Dr. Mercola Miracle Whey Protein Powder, dietary supplement, packaged in 1-lb. bottles and packed 6/1 lb-bottles per case. Distributed by Mercola Health Resources, LLC, Aurora, IL.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1839-2012·2012-08-08

    JFC International Recalls Oyster Products Due to Insanitary Conditions

    JFC International Inc. is recalling several oyster products because they were prepared or held under insanitary conditions, potentially rendering them injurious to health.

    Product
    Tablemark Kaki (Oyster) Fry, 2/12/6.34 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2012·2012-08-08

    Baxter Recalls Peritoneal Dialysis Solution Due to Incorrect Inspection Instructions

    Baxter Healthcare is recalling Extraneal and DIANEAL Low Calcium peritoneal dialysis solutions because a technical service representative provided incorrect instructions for inspecting solution bags.

    Product
    Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1822-2012·2012-08-08

    Spillson's Meatball Sub Sandwich Recalled for Undeclared Wheat

    Spillson's Ltd. is recalling Meatball Sub Sandwiches because the flour ingredient contains undeclared wheat. People with wheat allergies or sensitivities are at risk of serious or life-threatening reactions.

    Product
    Spillson's Ltd. Meatball Sub Sandwich Nt. Wt. 10 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2093-2012·2012-08-08

    Arm and Hammer Spinbrush Pro Clean Sonic Toothbrush Recall for Choking Hazard

    Church & Dwight is recalling 1.744 million Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrushes due to a potential small parts choking hazard.

    Product
    Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Food)·F-1832-2012·2012-08-08

    Spillson's Cheeseburger Sandwich Recalled for Undeclared Soy Lecithin

    Spillson's Ltd. is recalling Cheeseburger Sandwiches containing undeclared soy lecithin. The agency notes a risk of serious reaction for people with wheat allergies.

    Product
    Spillson's Ltd. Cheeseburger Sandwich.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2133-2012·2012-08-08

    Abbott i-Stat EG7 Cartridges Recalled for Inaccurate PCO2 Results

    Abbott Point of Care is recalling 52,750 i-Stat EG7 cartridges because they may produce falsely low PCO2 readings if stored at room temperature for four weeks or longer.

    Product
    I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2012·2012-08-08

    ICU Medical Flush Kits Recalled for Stopcock Molding Defect

    ICU Medical is recalling Flush Kits with 3 Way Off Stopcocks due to a molding defect that may occlude side ports.

    Product
    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2012·2012-08-08

    Stryker Recalls RF Cannulas Due to Packaging Error

    Stryker is recalling 226 units of RF Cannulas because 5mm and 10mm needles were incorrectly packaged in each other's boxes, posing a risk of thermal skin lesions.

    Product
    RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1829-2012·2012-08-08

    Spillson's Roast Beef Sandwich Recalled for Undeclared Wheat and Soy

    Spillson's Ltd. is recalling Roast Beef Sandwiches containing undeclared wheat and soy lecithin. Individuals with allergies to these ingredients are at risk of serious reactions.

    Product
    Spillson's Ltd. Roast Beef Sandwich 97% Fat Free, 7oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1825-2012·2012-08-08

    Spillson's Ham & Swiss Pita Sandwich Recalled for Undeclared Wheat

    Spillson's Ltd. is recalling 58 units of Ham & Swiss Pita Sandwiches due to undeclared wheat, posing a risk to people with wheat allergies.

    Product
    Spillson's Ltd. Ham & Swiss Pita Sandwich, 7 oz.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·12V380000·2012-08-06

    Mercedes-Benz Recalls 2011 G55 and G550 Due to Airbag Molding Strip Hazard

    Mercedes-Benz is recalling 2011 G55 and G550 vehicles because the front passenger airbag molding strip may become loose and act as a projectile during deployment, increasing injury risk.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ G55, G550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V384000·2012-08-03

    Glaval Transit Bus Recall for Roof Hatch Opening Force Defect

    Glaval Bus is recalling 2011-2012 models because roof escape hatches may require excessive force to open, potentially hindering emergency exits.

    Product
    GLAVAL BUS — GLAVAL BUS, GLAVAL ENTOURAGE, PRIMETIME, SPORT, UNIVERSAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12241·2012-08-02

    Patio Bistro Sets Recalled by CPSC Due to Chair Fall Hazard

    CPSC recalls patio bistro sets sold at Lowe's because chairs may not lock fully, posing a fall hazard. Thirteen injury reports were received.

    Product
    Patio Bistro Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide