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.

43151–43175 of 50511

  • HighFDA (Devices)·Z-1794-2013·2013-07-31

    Hill-Rom TotalCare Bed Recall Due to Mattress Egress Injury Risk

    Hill-Rom is recalling 4,121 TotalCare Beds because the mattress may not stay flat in the chair egress position, creating a risk of patients falling or sliding to the floor.

    Product
    TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2013·2013-07-31

    Physio Control Recalls LIFEPAK 500 AEDs Due to Assembly Error

    Physio Control is recalling 139 LIFEPAK 500 AEDs because an assembly error could cause internal shorting, rendering the device inoperable.

    Product
    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2013·2013-07-31

    Steris Recalls Fine Traction Devices Due to Bearing Defect

    Steris Corporation is recalling 16 units of Fine Traction Devices because a bearing failed pre-release reliability testing. The devices were distributed in five US states and Canada.

    Product
    STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V330000·2013-07-31

    Entegra Motorhomes Recalled for Windshield Wiper Arm Defect

    Entegra Coach is recalling 2013-2014 Anthem, Aspire, and Cornerstone motorhomes because the windshield wiper arm attachment could crack, reducing visibility.

    Product
    ENTEGRA — ENTEGRA ANTHEM, ASPIRE, CORNERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2013·2013-07-31

    Topcon PASCAL Laser Recall Due to Power Mismatch Risk

    Topcon Medical Laser Systems is recalling PASCAL and PASCAL Streamline lasers because a software function may cause power output mismatches, leading to over or under treatment.

    Product
    PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1785-2013·2013-07-31

    St. Jude Medical Recalls Eon and Eon Mini Charging Systems

    St. Jude Medical is recalling Eon and Eon Mini charging systems due to reported warmth or heating at the implant site during charging.

    Product
    Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2013·2013-07-31

    Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues

    Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.

    Product
    LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2013·2013-07-31

    Etac Swift Mobil Shower Chairs Recalled for Stability Risk

    Etac is voluntarily recalling Swift Mobil shower chairs because a lost caster can cause instant instability and potential injury.

    Product
    Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1748-2013·2013-07-31

    Jacqueline's Brownie Burst Cookies Recalled for Undeclared Milk Allergen

    Price Chopper is recalling Jacqueline's Brownie Burst Cookies due to an undeclared milk allergen. The product was distributed in six northeastern states.

    Product
    Jacqueline's GOURMET COOKIES Brownie Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling--Shelf life is 12 months frozen and 7 days after baked.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1798-2013·2013-07-31

    Becton Dickinson Recalls Vancomycin Screen Agar Due to Reduced Antimicrobial Levels

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the media may contain reduced levels of vancomycin, potentially affecting test accuracy.

    Product
    BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V331000·2013-07-31

    Jayco Recalls 2014 Precept Motorhomes Due to Wiper Arm Defect

    Jayco is recalling 2014 Precept motorhomes because the windshield wiper arm attachment may crack, potentially detaching the wiper and reducing visibility.

    Product
    JAYCO — JAYCO PRECEPT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2013·2013-07-31

    Ethicon Recalls Endopath Electrosurgery Probes Due to Potential Sterility Compromise

    Ethicon Endo-Surgery Inc is recalling 327,648 Endopath Electrosurgery Probe Plus II instruments because a tear in the Tyvek packaging may affect the sterility of the devices.

    Product
    Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-819-2013·2013-07-31

    Alkermes Recalls VIVITROL Vials Due to Sterility Assurance Concerns

    Alkermes, Inc. is recalling 3,325 vials of VIVITROL (naltrexone) because the product failed container closure integrity testing, raising concerns about sterility.

    Product
    VIVITROL — VIVITROL (NALTREXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2013·2013-07-31

    Pemco Rultract Retractor Ratchet Cover Plate Recalled for Corrosion

    Pemco Inc. is recalling 87 Rultract Retractor Ratchet Cover Plates because a returned unit showed signs of corrosion. The devices are used in surgery to lift incision sites.

    Product
    Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1795-2013·2013-07-31

    Siemens Axiom Aristos MX Flat Panel Imager Recalled for Finger Injury Risk

    Siemens is recalling 401 Axiom Aristos MX digital imagers because the table top float function can trap and crush fingers.

    Product
    Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13254·2013-07-31

    Be Amazing! Toys Recalls Water-Absorbing Polymer Balls Due to Ingestion Hazard

    Be Amazing! Toys is recalling Monster Science and Super Star Science Colossal Water Balls because the marble-sized toys can expand inside a child's body if ingested, causing intestinal obstructions.

    Product
    Water-Absorbing Polymer Balls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1729-2013·2013-07-31

    Amport Foods Recalls Vanilla Almond Granola Due to Metal Fragments

    American Importing Co. is voluntarily recalling 16 oz Vanilla Almond Granola packages that may contain pliable metal wire mesh fragments from a defective flour sifter.

    Product
    Smart Sense Fruit & Granola Trail Mix, Net WT 4.0 oz , UPC 8 83967 29091 8, Distributed by Kmart corporation, Hoffman Estates, Il 60179, Minneapolis, MN 55414.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-1728-2013·2013-07-31

    Amport Foods Recalls Vanilla Almond Granola Due to Metal Wire Fragments

    American Importing Co. is voluntarily recalling 16 oz Vanilla Almond Granola packages that may contain pliable metal wire mesh fragments from a defective flour sifter.

    Product
    Orchard Reserve, Fiber Health Blend, Net WT 6.5 oz , UPC 0 71725 74211 7, Distributed by Amport Foods, Minneapolis, MN 55414.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-1749-2013·2013-07-31

    Jacqueline's Raspberry Burst Cookies Recalled for Undeclared Milk Allergen

    Price Chopper is recalling Jacqueline's Raspberry Burst Cookies due to an undeclared milk allergen. The cookies were sold in several northeastern states.

    Product
    Jacqueline's GOURMET COOKIES Raspberry Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling---Shelf life is 12 months frozen and 7 days after baked.
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·13E041000·2013-07-30

    Cequent Recalls Tekonsha Electric Trailer Brake Control Wiring Adapters

    Cequent is recalling Tekonsha Electric Trailer Brake Control Wiring Adapters used on 2013 Dodge Ram 1500 vehicles because the turn signal may malfunction, increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V328000·2013-07-29

    Kawasaki Recalls 2013 Ninja 300 Motorcycles for ECU Stall Risk

    Kawasaki is recalling 2013 Ninja 300 motorcycles because an ECU error may cause the bike to stall during deceleration, increasing crash risk.

    Product
    KAWASAKI — KAWASAKI NINJA 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13744·2013-07-25

    Lennox and Superior gas fireplaces recalled due to gas leak risk

    Lennox Hearth Products is recalling about 11,500 gas fireplaces because defective connectors can leak gas, posing a fire hazard. No injuries have been reported.

    Product
    Lennox and Superior gas fireplaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13249·2013-07-25

    Home Depot Recalls Soleil Portable Fan Heaters Due to Fire Hazard

    Home Depot is recalling Soleil portable fan heaters because the plastic housing can melt and catch fire. Consumers should stop using the units and return them for a refund.

    Product
    Soleil portable fan heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide