The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

24651–24675 of 32189

  • SevereFDA (Drugs)·D-0122-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Polyhexamethylene Biguanide Eye Drops

    Martin Avenue Pharmacy is voluntarily recalling compounded polyhexamethylene biguanide eye drops due to quality control issues that risk sterility assurance.

    Product
    Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0160-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Tri-mix ST9-E, 30 mg/4 mg/150 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V704000·2014-11-05

    Ford Recalls Crown Victoria, Grand Marquis, Town Car for Steering Shaft Defect

    Ford is recalling 2005-2011 Crown Victoria, Grand Marquis, and Town Car vehicles where a prior steering shaft repair may have been incorrect, risking loss of steering control.

    Product
    LINCOLN — LINCOLN, FORD, MERCURY TOWN CAR, CROWN VICTORIA, GRAND MARQUIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0112-2015·2014-11-05

    Martin Avenue Pharmacy Recalls PGE 2 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling PGE 2 injectable vials due to quality control issues affecting sterility assurance.

    Product
    PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0095-2015·2014-11-05

    Hospira Recalls GemStar Power Supplies Due to Power Delivery Failure

    Hospira is recalling 978 GemStar Power Supplies because they may fail to provide power to the infusion pump, resulting in smoke.

    Product
    The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Drugs)·D-0120-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Phenylephrine 10% Ophthalmic Solution

    Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 10% ophthalmic solution due to quality control issues that risk sterility assurance.

    Product
    Phenylephrine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0154-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix SEST 4 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix SEST 4 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0142-2015·2014-11-05

    Mabis Recalls DMI Rollator Transport Chairs Due to Collapse Risk

    Briggs Medical Service Company is recalling 1,869 DMI Rollator Transport Chairs because they may collapse during use.

    Product
    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0076-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Dexamethasone sodium phosphate 4 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Dexamethasone sodium phosphate 4 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0096-2015·2014-11-05

    Real Foods Recalls Mexican Cheddar Dip for Missing Egg Labeling

    Real Foods of Seattle is recalling 96 units of Mexican Cheddar Dip because egg is missing from the ingredient statement.

    Product
    Mexican Cheddar Dip 10oz non-flex plastic, distributed by Taylor Farms Salinas, CA 93902. The label will show UPC 0 3022300960 9 or UPC 0 30223 00952 8
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0112-2015·2014-11-05

    FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

    The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0123-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Polyhexamethylene biguanide 2% stock solution, due to quality control issues affecting sterility assurance.

    Product
    Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0072-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyanocobalamin, due to quality control observations that risk sterility assurance.

    Product
    Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Phenol 10% Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Phenol 10% injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Phenol 10% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0066-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Cefazolin Ophthalmic Solution for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Cefazolin ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Fentanyl Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable syringes due to quality control issues that may compromise sterility assurance.

    Product
    Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14T014000·2014-11-04

    Toyo Recalls Tires Due to Tread and Belt Separation Risk

    Toyo is recalling specific OPEN Country H/T Tuff Duty and Nitto Dura Grappler tires because stress may cause tread or belt separation, increasing crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V698000·2014-11-04

    Porsche Recalls 2014-2015 Models Due to Hood Latch Defect

    Porsche is recalling 2014-2015 911, Boxster, and Cayman vehicles because the front hood latch may fail, potentially opening the hood and blocking the driver's view.

    Product
    PORSCHE — PORSCHE BOXSTER, CAYMAN, 911
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V700000·2014-11-04

    Honda Recalls Multiple Models for Air Bag Inflator Rupture Risk

    Honda is recalling specific 2001-2006 models sold in high-humidity areas because the passenger air bag inflator may rupture during deployment.

    Product
    HONDA — HONDA, ACURA CIVIC HYBRID, PILOT, RIDGELINE, RL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V699000·2014-11-04

    Keystone Recalls 2015 Laredo Trailers Due to Fire Risk

    Keystone RV Company is recalling 2015 Laredo trailers because a circuit breaker may rub against the propane cylinder, increasing the risk of fire.

    Product
    KEYSTONE — KEYSTONE LAREDO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V690000·2014-11-03

    Airstream Recalls 2014-2015 Travel Trailers Due to Electrical Fire Risk

    Airstream is recalling 2014-2015 travel trailers because loose power inlet receptacles may cause excessive heat and vehicle fire.

    Product
    AIRSTREAM — AIRSTREAM LAND YACHT, FLYING CLOUD, INTERNATIONAL, SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V685000·2014-10-31

    Eldorado Recalls 2008-2009 Vehicles Due to Accelerator Pedal Spring Defect

    Eldorado is recalling 2008-2009 Axess, E-Z Rider II, XHF, Escort RE-A, and Transmark RE vehicles because accelerator pedal springs may break, causing unintended acceleration.

    Product
    ELDORADO — ELDORADO TRANSMARK RE, ESCORT RE-A, XHF, AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide