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.

38151–38175 of 50506

  • HighFDA (Devices)·Z-2079-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 28 Sorin Stockert Heater-Cooler 3T devices due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2842-2015·2015-07-22

    Khara Enterprises Recalls Baked Samosa Sweet Potato for Undeclared Soy

    Khara Enterprises is recalling Baked Samosa Sweet Potato products because they contain undeclared soy lecithin, a major allergen.

    Product
    Baked Samosa Sweet Potato (Baked Indian pastry with a savory filling), Frozen package, Net wt. 7.5 oz., No UPC
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2076-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA, Inc. is recalling 2,837 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2015·2015-07-22

    Stryker Woundcare Replacement Kits Recalled for Potential Sterility Breach

    Stryker is recalling Woundcare Replacement Kits used for wound debridement due to a potential sterility breach in the packaging.

    Product
    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2015·2015-07-22

    Northern Digital recalls disposable reflective marker spheres for surgical tracking

    Northern Digital Inc. is recalling 32,400 disposable reflective marker spheres used in Brainlab IGS systems due to inadequate adhesive curing that may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2845-2015·2015-07-22

    Ford Gum Recalls Project 7 Caramel Apple Sugar Free Gum for Undeclared Milk

    Ford Gum & Machine Company is recalling Project 7 Caramel Apple Sugar Free Gum because it contains undeclared milk. The product was distributed in California.

    Product
    Project 7 CARAMEL APPLE Sugar Free Gum, approximately 32 lbs. -- Manufactured by: Ford Gum and Machine Company, 18 Newton Ave., Akron, New York 14001 --- The product was supplied in cardboard bulk boxes. with a label reading, "Project 7 CARAMEL APPLE, approximately 32 pounds…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2059-2015·2015-07-22

    Exactech Spine Set Screw Recalled for Incorrect Thread Form

    Exactech, Inc. is recalling 749 Altiva Large Set Screws due to incorrect thread form. The devices were distributed in six states.

    Product
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·15V460000·2015-07-22

    Chrysler Recalls 2013-2015 Ram Trucks for Air Bag Deployment Risk

    Chrysler is recalling 2013-2015 Ram 1500, 2500, and 3500 trucks because side air bags and seat belts may deploy unexpectedly, increasing crash risk.

    Product
    RAM — RAM 3500, 2500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2015·2015-07-22

    Etac Supporter toilet armrest recalled due to loose fasteners

    Etac Supply Center Ab is recalling 25 units of Supporter toilet armrests because fasteners may come loose, causing the product to become unsteady.

    Product
    Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 283 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection is not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2015·2015-07-22

    Alere i Influenza A & B Kit Recalled for False Negative Risk

    Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.

    Product
    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2853-2015·2015-07-22

    Kraft Recalls Capri Sun Fruit Punch Juice Drink Blend

    Kraft Foods North America is recalling Capri Sun Fruit Punch Flavored Juice Drink Blend due to possible brass fragments in the product.

    Product
    CapriSun Variety Pack, with a multi colored plastic wrap with white and yellow lettering, covering 4 cartons. The 4 cartons consist of fruit punch (the effected product), wild cherry, pacific cooler, and strawberry kiwi.Fruit Punch Flavored Juice Drink Blend in a blue box with…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2084-2015·2015-07-22

    NDI Disposable Reflective Marker Spheres Recalled for Adhesive Defect

    Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres because inadequate adhesive curing may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2015·2015-07-22

    Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk

    Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.

    Product
    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V458000·2015-07-22

    Kenworth Trucks Recalled for Hazard Light Override Defect

    PACCAR is recalling 2011-2016 Kenworth trucks because daytime running lamps may override hazard warning lights, increasing crash risk.

    Product
    KENWORTH — KENWORTH T440, T470, T880, T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2015·2015-07-22

    Sorin Heater-Cooler Devices Recalled for Potential Microbial Colonization

    Sorin Group USA is recalling Stockert Heater-Cooler 3T devices due to the potential for microbial colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15E062000·2015-07-17

    H&H Sports Protection Recalls VCAN V528 Milano Motorcycle Helmets

    H&H Sports Protection is recalling VCAN V528 Milano motorcycle helmets because the retention systems failed testing and required labeling is missing.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15T014000·2015-07-17

    Continental ContiProContact Tires Recalled for Bead Air Leak Defect

    Continental is recalling specific ContiProContact tires manufactured in early 2015 because a manufacturing error may cause air leaks from the bead area, increasing the risk of sudden tire failure and a crash.

    Product
    TIRES:BEAD recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15742·2015-07-17

    EKO Recalls Motion Sensor Trash Cans Due to Laceration Hazard

    EKO is recalling motion sensor trash cans sold at Costco because a protective collar can dislodge, exposing a sharp edge that poses a laceration risk.

    Product
    Trash cans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15187·2015-07-16

    Cash Acme Heatguard TAFR Devices Recalled Due to Scald Hazard

    Reliance Worldwide is recalling Cash Acme Heatguard TAFR devices because a thermal failure could cause scalding injuries. About 26,000 units are affected.

    Product
    Cash Acme Heatguard Temperature Actuated Flow Reducing (TAFR) Device
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2820-2015·2015-07-15

    Southern Style Spices Recalls Ground Cumin for Peanut Protein

    Southern Style Spices is recalling 775 lbs of ground cumin distributed in Texas because it may contain peanut protein.

    Product
    Cumin, Ground NET WT. 50 LBS. DISTRIBUTED BY: SOUTHERN STYLE SPICES PO BOX 20 MANOR, TX 78653 PHONE: (512)272-5621
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2811-2015·2015-07-15

    Boba Direct Vanilla Bubble Tea Powder Recalled for Undeclared Allergens

    Boba Direct, Inc. is recalling vanilla bubble tea powder sold in foil bags due to undeclared allergens. The product was distributed in five states.

    Product
    Foil bags containing 2.2 lbs. each of vanilla flavored powder and sold under the Boba Direct, Inc. brand.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2794-2015·2015-07-15

    Boba Direct Blueberry Powder Recalled for Undeclared Allergens

    Boba Direct, Inc. is recalling blueberry flavored powder due to undeclared allergens. The product was distributed in five US states.

    Product
    Foil bags containing 2.2 lbs. each of blueberry flavored powder and sold under the Boba Direct, Inc. brand.
    Category
    Food
    Distribution
    5 states