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.

41426–41450 of 50511

  • HighFDA (Devices)·Z-1433-2014·2014-04-16

    Aspen Surgical Products Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.

    Product
    19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1421-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.

    Product
    Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1749-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters because soy was not declared on the label.

    Product
    i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters. UPC 736211802446 for the 4 oz UPC 713757598101 for the 1 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recall for Software Communication Failure

    Philips is recalling HeartStart XL+ Defibrillators because a software failure may lock users out of clinical mode, potentially delaying therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling 7mm Drain Kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1446-2014·2014-04-16

    Breg Recalls Knee Sleeves for Missing Latex Warning Labels

    Breg Inc is recalling specific knee sleeves because they contain latex but lack the required caution labels.

    Product
    Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.

    Product
    10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1336-2014·2014-04-16

    Playtex Electric Breast Pump Recall Due to Power Adapter Shock Risk

    Energizer Personal Care is recalling Playtex Deluxe Double Electric Breast Pumps because loose power adapter casings may cause electric shock.

    Product
    Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2014·2014-04-16

    Harbor Freight Recalls Sit/Stand Rolling Walkers Due to Wheel Detachment Risk

    Harbor Freight Tools is recalling Sit/Stand Rolling Walkers because wheels may detach over time, posing a hazard to users.

    Product
    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1209-2014·2014-04-16

    Terra-Medica Recalls Pleo Ex Suppositories Due to Penicillin Cross-Contamination

    Terra-Medica Inc. is recalling Pleo Ex Suppositories because of penicillin cross-contamination. The affected homeopathic antifungal products were distributed in the US, Canada, and the Philippines.

    Product
    Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1205-2014·2014-04-16

    Terra-Medica Recalls Pleo Fort Capsules Due to Penicillin Cross Contamination

    Terra-Medica Inc. is recalling Pleo Fort Capsules 4X due to penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.

    Product
    Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1747-2014·2014-04-16

    Northern Valley Baking Recalls G'nache P'nache for Undeclared Milk and Soy

    Northern Valley Baking Co. is recalling G'nache P'nache products because milk and soy were not declared on the allergen statement.

    Product
    The Other Macaroon G'nache P'nache 5.3 oz. Manufactured and Distributed by:Northern Valley Baking Co LLC, Dumont, New Jersey USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.

    Product
    5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1435-2014·2014-04-16

    Aspen Surgical Recalls Sterile Drain Kits Due to Sterility Compromise

    Aspen Surgical Products is recalling specific sterile drain kits and bulb evacuators because the sterile barrier may be compromised.

    Product
    7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1452-2014·2014-04-16

    Draeger Recalls Reusable Latex Breathing Bags Due to Allergic Reaction Incident

    Draeger Medical is recalling reusable latex breathing bags and test lungs after a user reported an acute allergic reaction. The product is distributed nationwide.

    Product
    Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for Potential Damage

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use.

    Product
    5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1759-2014·2014-04-16

    Bay State Milling Recalls Wing Bran Due to Metal Fragments

    Bay State Milling is voluntarily recalling specific lots of Wing Bran produced in February and March 2014 due to the presence of metal fragments.

    Product
    Wing Bran-Bkrs 40# 30/PAL720600, #14535 , Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72060 5, Ingredients Wheat Bran. Wingold Bran - Bakers 40#720500, Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72050 6, Ingredients What Bran.
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1450-2014·2014-04-16

    Medcare Floor Lifts Recalled Due to Potential Pin Failure

    ErgoSafe Product LLC is recalling Medcare Floor Lifts manufactured between 2010 and 2012 because a design pin may break over time.

    Product
    400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1818-2014·2014-04-16

    Command Nutritionals Recalls Juggernaut and Hard Blast Drinks for Contaminated Ingredient

    Command Nutritionals is recalling Juggernaut and Hard Blast-Pink Lemonade products due to contaminated L-Citrulline received from a supplier.

    Product
    Juggernaut a) Crimson Punch UPC 811020906803 b) Orange UPC 811020906841 c) Raspberry Lemonade UPC 811020906858 Net Wt. 1.76 lbs. Manufactured in the USA Infinite Labs, LLC PO Box 533736 Orlando, FL 32853 1-877-455-2271
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1431-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1752-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Cranberry Cashew Quinoa Clusters because soy lecithin was used in manufacturing but not declared on the label.

    Product
    i heart keenwah Cranberry Cashew All Natural Quinoa Clusters. UPC 736211802545 for the 4 oz UPC 713757598309 for the 1 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1751-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Ginger Peanut All Natural Quinoa Clusters because an anti-stick spray containing soy lecithin was used during manufacturing, but soy was not declared on the label.

    Product
    i heart keenwah Ginger Peanut All Natural Quinoa Clusters. UPC 736211802644 for the 4 oz UPC 713757598408 for the 1 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2014·2014-04-16

    Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks

    Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged.

    Product
    Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recalled for Therapy Board Malfunction

    Philips is recalling 19 HeartStart XL+ defibrillators because a therapy board component could malfunction, potentially affecting the device's ability to deliver therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    2 states