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.

36751–36775 of 50504

  • HighFDA (Drugs)·D-0589-2016·2016-02-03

    Pharmakon Recalls Subpotent Epinephrine Injectable Syringes Nationwide

    Pharmakon Pharmaceuticals is recalling 1,150 syringes of Epinephrine (PF) 10 mcg/mL because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0593-2016·2016-02-03

    Pharmakon Recalls Subpotent Midazolam Injectable Syringes Nationwide

    Pharmakon Pharmaceuticals is recalling 210 syringes of Midazolam (PF) 0.5 mg/mL because the drug is subpotent. The recall is voluntary and nationwide.

    Product
    Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0615-2016·2016-02-03

    Sentara Recalls Cefazolin Due to Lack of Sterility Assurance

    Sentara Enterprises is recalling specific lots of Cefazolin because the sterility of the product cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.

    Product
    CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0690-2016·2016-02-03

    Globalmed Logistix Recalls Lipogems SPA Aspiration Cannulae Due to Bending Risk

    Globalmed Logistix is recalling 118 units of Lipogems SPA Aspiration Cannulae because they may bend during procedures. The affected sterile cannulae were distributed to seven states.

    Product
    Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0643-2016·2016-02-03

    Sentara Recalls Dextrose-5% Lactated Ringers Due to Sterility Concerns

    Sentara Enterprises is recalling 7 bags of Dextrose-5% Lactated Ringers because the sterility of the product cannot be guaranteed.

    Product
    Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0613-2016·2016-02-03

    Sentara Recalls Sodium Chloride Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Sodium Chloride Homepumps because the sterility of the product cannot be guaranteed.

    Product
    SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy…
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0651-2016·2016-02-03

    Midmark Vantage Panoramic X-Ray System Recalled for Collimator Failure

    Midmark Corp dba Progeny Inc is recalling 832 Vantage Panoramic X-Ray Systems because a primary collimator failure may cause unintentional movement without an error message.

    Product
    Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures.…
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Drugs)·D-0636-2016·2016-02-03

    Sentara Recalls Lactated Ringers Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of Lactated Ringers because product sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0693-2016·2016-02-03

    Fresenius Liberty Cycler Peritoneal Dialysis Machines Recalled for Door Latch Defect

    Fresenius Medical Care is recalling 14,094 Liberty Cycler peritoneal dialysis machines because the door latch may not fully close, posing a risk of injury or treatment delay.

    Product
    Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V062000·2016-02-03

    Forest River Recalls 2016 Surveyor RVs Due to Wiring Defect

    Forest River is recalling 12 model year 2016 Surveyor recreational vehicles because incorrect wiring may allow excessive current, posing an electrocution risk.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2016·2016-02-03

    Bio-Rad D-10 Rack Loader Recalled for Potential Sample ID Error

    Bio-Rad is recalling D-10 Rack Loaders because a rare configuration issue could assign patient results to incorrect sample IDs.

    Product
    D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16091·2016-02-03

    Lutron Recalls Roller Shades Due to Falling Impact Hazard

    Lutron Electronics is recalling about 30,000 Serena and SIVOIA QS TRIATHLON roller shades because they can fall from brackets, posing an impact hazard.

    Product
    Roller Shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0616-2016·2016-02-03

    Sentara Recalls Milrinone Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Milrinone in 0.45% NS homepumps because the sterility of the product cannot be guaranteed.

    Product
    Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML…
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-0515-2016·2016-02-03

    Mandarin Oranges Recalled for Possible Glass Contamination

    Milky Way Intl Trading Corp is recalling Mandarin Oranges due to possible glass in the product. The recall affects 8,309 cases distributed to Walgreens stores nationwide.

    Product
    Mandarin Oranges (In Light Syrup), Net Wt. 8oz (227g), Case UPC#: 100-49022-80895-6, Product UPC#: 0-49022-80895-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·16088·2016-02-02

    Dirt Devil Pet Vacuums Recalled for Electrical Shock Hazard

    Royal Appliance is recalling about 149,000 Dirt Devil Total Pet Cyclonic Upright vacuums in the U.S. because a cord prong can detach and remain in the outlet, posing an electrical shock risk.

    Product
    Dirt Devil® Total Pet Cyclonic Upright
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16082·2016-02-02

    Scubapro Recalls Galileo Luna and Sol Dive Computers Due to Screen Freezing

    Scubapro is recalling about 1,500 Galileo Luna and Sol dive computers because a short circuit can cause the screen to freeze or display inaccurate information, posing a risk of serious injury.

    Product
    Galileo Luna and Sol Dive Computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16C002000·2016-02-02

    Graco Recalls Extend2Fit Child Seats Due to Incorrect Recline Labeling

    Graco is recalling Extend2Fit convertible child seats manufactured between November 2015 and January 2016 because the recline label is affixed in the wrong location, which may lead to improper installation.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V054000·2016-02-01

    GM Recalls 2015 Chevrolet Colorado and GMC Canyon for Steering Defect

    General Motors is recalling 2015 Chevrolet Colorado and GMC Canyon trucks because a poor electrical connection may cause a loss of power steering assist, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET CANYON, COLORADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V053000·2016-02-01

    Lexus Recalls RX Models Due to Knee Air Bag Weld Defect

    Toyota is recalling 2016 Lexus RX350 and RX450h vehicles because an improper weld may cause the driver's knee air bag inflator to leak gas, increasing injury risk in a crash.

    Product
    LEXUS — LEXUS RX HYBRID, RX350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16087·2016-01-28

    i play Recalls Glass Food Storage Cubes Due to Injury Hazard

    i play is recalling green sprouts glass food storage cubes because the glass can break unexpectedly, posing a risk of injury.

    Product
    green sprouts® glass food cubes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V057000·2016-01-28

    Hyundai Recalls 2011 Tucson Vehicles for Transmission Fluid Leak Risk

    Hyundai is recalling 11,176 model year 2011 Tucson vehicles because a defective transmission fluid cooler hose may leak, potentially causing the vehicle to stop moving and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16086·2016-01-28

    Varaluz Recalls Longfellow Light Fixtures Due to Fire and Shock Hazards

    Varaluz is recalling about 80 Longfellow lighting fixtures because improper wiring can cause melting, shorting, fire, and shock. Consumers should stop using the fixtures and contact the company for a replacement or refund.

    Product
    Longfellow lighting fixtures for indoor and outdoor use
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2016·2016-01-27

    Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise

    Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide