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.

42876–42900 of 50511

  • HighFDA (Devices)·Z-2136-2013·2013-09-11

    Stelkast Recalls Distal Femoral Augments Due to Sterility Breach

    Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.

    Product
    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling 110 units of LeGoo Endovascular Occlusion Gel 0.5 mL because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 250 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V407000·2013-09-11

    BMW Recalls 2008-2010 Models for Taillight Electrical Contact Issues

    BMW is recalling 2008-2010 528i, 535i, 550i, and M5 vehicles because increased electrical resistance may cause rear lamp failure, reducing visibility to other drivers.

    Product
    BMW — BMW 535I, 550I, 528I, M5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1867-2013·2013-09-11

    Thrive Foods Recalls 6 Grain Pancake Mix Due to Can Pressure Risks

    Thrive Foods is recalling 6 Grain Pancake Mix because ingredients react over time, increasing can pressure and the risk of injury when opened.

    Product
    THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02) (the "Gallon Cans"); and (2) 1.17 lb. Pull-Top Pantry Cans (4.01x 5.08) (the "Pantry Cans"). Both units are packaged in metal cans. The Pantry Can has a metal pull-top lid and the…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·13282·2013-09-11

    L.L.Bean Recalls Boat Carts Due to Bursting Plastic Wheel Rims

    L.L.Bean is recalling Deluxe Packaway Boat Carts because plastic wheel rims can burst when tires are over-inflated, posing an injury risk.

    Product
    L.L.Bean Deluxe Packaway Boat Carts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates

    Genzyme Corporation is recalling 776 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates

    Genzyme is recalling LeGoo Internal Vessel Occluder 5mL units because they contain fiber particulates. The recall covers 308 units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1870-2013·2013-09-11

    H-E-B Jumbo Butterfly Shrimp Recalled for Unlabeled Coconut

    The Seafood Exchange of Florida is recalling H-E-B Jumbo Butterfly Shrimp because the product contains coconut, which is not listed on the label.

    Product
    H-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2148-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme is recalling LeGoo Internal Vessel Occluder devices because they contain particulates (fibers). The recall affects 448 units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2013·2013-09-11

    MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise

    MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 65 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers lots distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13284·2013-09-11

    Hachette Recalls Children's Books Due to Choking and Laceration Hazards

    Hachette Book Group is recalling two children's board books because a metal rod with beads can detach, posing choking and laceration risks.

    Product
    Children's books titled "Count my Kisses, 1, 2, 3" and "Red, Green, Blue, I Love You"
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 652 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 37 units of LeGoo Internal Vessel Occluder 10mL because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2159-2013·2013-09-11

    MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals

    MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1863-2013·2013-09-11

    Tortillas Lupita Flour Tortillas Recalled for Undeclared Soy

    Tortillas Lupita Flour Tortillas are being recalled because they contain undeclared soy lecithin and soybean oil.

    Product
    Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2134-2013·2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System Kits

    DePuy Spine is recalling Confidence Spinal Cement System Kits because hydraulic pump leaks can cause loss of pressure during cement injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or…
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2147-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 181 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2013·2013-09-11

    Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.

    Product
    ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 331 units of LeGoo Internal Vessel Occluder 2.5mL because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling 45 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
    Category
    Medical Device
    Distribution
    Distributed nationwide