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.

44526–44550 of 50511

  • HighFDA (Devices)·Z-0267-2013·2012-11-14

    Medacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk

    Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.

    Product
    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0257-2013·2012-11-14

    Kimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure

    Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.

    Product
    ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0595-2013·2012-11-14

    Turkey Hill Ice Cream Recalled for Undeclared Coconut Allergen

    Turkey Hill Mint Chocolate Chip Ice Cream is being recalled because it contains undeclared coconut, a potential allergen.

    Product
    Turkey Hill Mint Chocolate Chip All Natural Ice Cream, 48 oz, UPC 0-20735-11203-8
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0601-2013·2012-11-14

    Kellogg's Mini-Wheats Cereal Recalled for Possible Metal Fragments

    Kellogg's is voluntarily recalling specific Mini-Wheats cereal products due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Kellogg's Mini Wheats, Unfrosted, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 18 oz carton; 70 ct case single serve; Canadian: Kellogg's Mini-Wheats Original cereal 12 ct, 850 G
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0600-2013·2012-11-14

    Kellogg's Frosted Mini-Wheats Cereal Recalled for Metal Mesh Fragments

    Kellogg's is voluntarily recalling Frosted Mini-Wheats cereal due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Kellogg's Frosted Mini Wheats , Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 96 ct case single serve,each Nt. Wt. 1 oz (28g); 18 oz carton; 24 oz carton; 30 oz., 70 ct case single serve, 70 oz carton Canadian product: Kellogg's Mini-Wheats Original Frosted Cereal 440…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2013·2012-11-14

    FDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips

    Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0208-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 73 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13034·2012-11-13

    Rec-Out Recalls Columbus Folding Camping Chairs Due to Mold Presence

    Rec-Out is recalling Columbus folding camping chairs sold at Big 5 Sporting Goods because they contain mold that could cause infections in vulnerable individuals.

    Product
    Folding Camping Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13036·2012-11-13

    Powermate Sx 5500 Portable Generators Recalled for Fire Hazard

    Pramac America is recalling Powermate Sx 5500 portable generators because a defective fuel filter allows gasoline to leak, posing a fire hazard.

    Product
    Powermate Sx 5500 portable generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13705·2012-11-08

    2013 Diamondback Steilacoom RCX Bicycles Recalled for Crash Hazard

    CPSC recalls about 40 2013 Diamondback Steilacoom RCX bicycles because incorrect headset parts could cause the steerer tube to fail, leading to a crash.

    Product
    2013 Diamondback Steilacoom RCX bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13033·2012-11-08

    Monessen Hearth Systems Recalls Gas Fireplaces Due to Fire Risk

    Monessen Hearth Systems is recalling about 15,000 gas fireplaces and inserts because a control component may prevent lighting while gas continues to flow, posing a fire hazard.

    Product
    Signature Command™ (electronically) Controlled Direct and B-Vent Gas Fireplaces and Inserts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13032·2012-11-08

    LaJobi Recalls Graco Glider Rockers Due to Base Breakage and Fall Hazard

    LaJobi is recalling Graco-branded Avalon and CNS Box 2 glider rockers because the base can crack or break, posing a fall hazard. Consumers should stop using the products and contact LaJobi for a free replacement base.

    Product
    Graco®-branded Avalon Glider Rockers with Ottoman and Complete Nursery Solution (CNS) Box 2 / Katelyn Nursery Solution Glider Rockers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13031·2012-11-08

    LG Electric Ranges Recalled Due to Burn and Fire Hazards

    LG Electronics is recalling about 161,000 electric ranges because burners may fail to turn off or heat unexpectedly, posing burn and fire risks.

    Product
    LG Electric Ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13029·2012-11-07

    Scuba Diving Hoses Recalled by Three Companies Due to Rupture Hazard

    Innovative Scuba Concepts, Trident Diving, and A-Plus Marine are recalling high-pressure scuba air hoses that can rupture, posing a drowning hazard.

    Product
    High pressure scuba diving air hoses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2013·2012-11-07

    Oscor Recalls Myocardial Heart Wires Due to Spacing Defect

    Oscor, Inc. is recalling specific models of myocardial heart wires because the spacing between the anchoring zig-zag and the electrode is out of specification.

    Product
    Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0160-2013·2012-11-07

    Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Connector Detachment Risk

    Maquet Cardiovascular is recalling QUADROX oxygenators because the blood outlet connector may detach from the device during use.

    Product
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2013·2012-11-07

    Sorin SCP Pump Control Panel Recalled for Circuit Board Malfunction

    Sorin Group USA is recalling SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0581-2013·2012-11-07

    Popcorn Indiana Bacon Ranch Popcorn Recalled for Listeria Risk

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Bacon Ranch Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Bacon Ranch Popcorn Net Wt. 3.5 oz - UPC 843571001942 Net Wt. 7.75 oz - UPC 843571001935 Net Wt. 8.3oz. - UPC 843571001935 Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2013·2012-11-07

    Progressive Medical Recalls Endoscopic Dissector Due to Tip Unraveling Risk

    Progressive Medical Inc is recalling 124 boxes of PMI Endoscopic Dissectors because the tip could come loose or unravel during use.

    Product
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2013·2012-11-07

    Varian ARIA Radiation Oncology Software Recall Due to Treatment Plan Error

    Varian Medical Systems is recalling ARIA Radiation Oncology Version 11 software because monitor units may be incorrect when continuing partial treatment.

    Product
    ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0584-2013·2012-11-07

    Popcorn Indiana Almond Biscotti Caramel Popcorn Recalled for Listeria Risk

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Almond Biscotti Caramel Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Almond Biscotti Caramel Popcorn Net Wt. 6.5 oz. UPC 843571003809 Net Wt. 7 oz UPC 843571003854 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0593-2013·2012-11-07

    Popcorn Indiana Wasabi Reserve Popcorn Recalled for Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Wasabi Reserve Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Wasabi Reserve Popcorn Net Wt. 5.5 oz UPC 843571002048 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide