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.

14851–14875 of 29202

  • SevereFDA (Devices)·Z-0508-2018·2018-02-14

    Siemens Artis Biplane Systems Recalled for Ceiling Mount Defect

    Siemens is recalling 265 Artis zee and Artis Q biplane systems because ceiling mount screws may not be fastened correctly.

    Product
    AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0559-2018·2018-02-14

    Recall of Emprint Percutaneous Antenna Due to Tip Disengagement Risk

    FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0790-2018·2018-02-14

    Hiland Dairy Foods Recalls Tampico Citrus Punch Due to Undeclared Milk

    Hiland Dairy Foods is recalling 1,157 gallons of Tampico Citrus Punch because milk was detected in the product, despite not being listed on the label.

    Product
    Tampico Citrus Punch, 1 GAL (3.78 L) Tampico Beverages, Chicago, IL
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0558-2018·2018-02-14

    Recall of Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0763-2018·2018-02-14

    Mallorca Guava Queso Recalled for Undeclared Soy and Potassium Sorbate

    Productos Pacheco, Inc. is recalling Mallorca Guava Queso because it contains undeclared soy and potassium sorbate. The product was distributed to consignees in Puerto Rico.

    Product
    Mallorca Guava Queso NET WT 4OZ
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0326-2018·2018-02-14

    Flawless Beauty Recalls Tatiomax Glutathione Whitening Kits Nationwide

    Flawless Beauty LLC is voluntarily recalling Tatiomax Glutathione Whitening kits nationwide because the products were marketed without FDA approval.

    Product
    Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0806-2018·2018-02-14

    Panera Cream Cheese Recalled Due to Listeria Contamination Risk

    Panera, LLC is recalling Reduced-Fat Plain Cream Cheese (2 oz. and 8 oz.) because it may be contaminated with Listeria monocytogenes. The product was sold nationwide at Panera Cafes.

    Product
    Panera Reduced-Fat Plain Cream Cheese, 2 oz. and 8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·18098·2018-02-14

    ISO Beauty Recalls Ionic Pro Hair Dryers Due to Burn Hazard

    ISO Beauty is recalling Ionic Pro hair dryers because the cord can become brittle, posing a burn hazard. Consumers should stop using the units and contact the company for a refund.

    Product
    Ionic Pro hair dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0560-2018·2018-02-14

    Recall of Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0759-2018·2018-02-14

    Mallorcas Pacheco Recalled for Undeclared Soy Allergen

    Productos Pacheco, Inc. is recalling Mallorcas Pacheco 1LB packages due to undeclared soy. The product was distributed to consignees in Puerto Rico.

    Product
    Mallorcas Pacheco NET WT 1LB (16OZ)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0322-2018·2018-02-14

    FDA Recalls Sterile Morphine Sulfate Preparations Due to Sterility Concerns

    Intrathecal Compounding Specialist, LLC is recalling sterile morphine sulfate preparations compounded between October 16 and November 17, 2017, due to a lack of sterility assurance.

    Product
    All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2018·2018-02-14

    Flawless Beauty Recalls Unapproved Glutathione Injectable Products Nationwide

    Flawless Beauty LLC is voluntarily recalling all lots of Tationil Glutathione and other products sold in kits. The recall is due to misbranding and the sale of unapproved new drugs under a court order.

    Product
    Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0321-2018·2018-02-14

    FDA Recalls Hydromorphone Sterile Drug Preparations for Lack of Sterility Assurance

    Intrathecal Compounding Specialist is recalling sterile drug preparations made from Hydromorphone Base Solution due to a lack of sterility assurance.

    Product
    All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0770-2018·2018-02-14

    Vanilla Cake with Cheese and Guava Recalled for Undeclared Allergens

    Productos Pacheco, Inc. is recalling 12-ounce Vanilla Cake with Cheese and Guava due to undeclared allergens including wheat and soy.

    Product
    Bizcocho Vainilla con Queso y Guava [Vanilla Cake with Cheese and Guava] NET WT 12OZ
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0760-2018·2018-02-14

    Bread Recalled for Undeclared Soy Allergen in Puerto Rico

    Productos Pacheco, Inc. is recalling 1-pound loaves of bread sold in Puerto Rico because they contain undeclared soy.

    Product
    Pan [bread] NET WT 1LB (16OZ)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0332-2018·2018-02-14

    Flawless Beauty Recalls Sterilized Water for Injections Due to Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections sold in the U.S. because the products were marketed without FDA approval.

    Product
    Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0557-2018·2018-02-14

    Recall of Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA Class II recall of Covidien Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft and remain in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0761-2018·2018-02-14

    Bread with Raisins Recalled for Undeclared Wheat, Soy, and Egg Allergens

    Productos Pacheco, Inc. is recalling Pan con pasas bread due to undeclared wheat, soy, and egg allergens. The product was distributed to consignees in Puerto Rico.

    Product
    Pan con pasas [Bread with raisins] NET WT 1LB (16OZ)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0554-2018·2018-02-14

    Mindray TD60 Transmitter Battery Charger Recalled for Overcharging Risk

    Mindray is recalling 203 TD60 Transmitter battery chargers used with the BeneVision Central Station because a damaged circuit board can cause the battery to overcharge and the case to swell.

    Product
    TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Drugs)·D-0335-2018·2018-02-14

    Flawless Beauty Recalls Unapproved Glutathione Whitening Injection Kits

    Flawless Beauty LLC is voluntarily recalling all lots of TAD Glutathione Whitening Kits because the products were marketed without FDA approval.

    Product
    TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2018·2018-02-14

    Flawless Beauty LLC Recalls Ling Zhi Capsules for Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of Ling Zhi capsules because they were marketed without an approved NDA/ANDA, constituting misbranding and unapproved new drugs.

    Product
    Ling Zhi capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0769-2018·2018-02-14

    Vanilla Cake with Guava Recalled for Undeclared Allergens

    Productos Pacheco, Inc. is recalling Vanilla Cake with Guava due to undeclared wheat, soy, milk, Red # 40, and potassium sorbate.

    Product
    Bizcocho de Vainilla con Guava [Vanilla Cake with Guava] NET WT 4OZ and 12OZ
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0765-2018·2018-02-14

    Pound Cake Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Productos Pacheco, Inc. is recalling Pound Cake (4 oz and 12 oz) due to undeclared wheat, soy, and milk allergens. The product was distributed to Puerto Rico consignees.

    Product
    Pound Cake NET WT 4OZ and 12OZ.
    Category
    Food
    Distribution
    0 states
  • SevereUSDA FSIS·010-2018·2018-02-14

    Saker ShopRites Recalls Pork and Chicken Empanadas Due to Undeclared Egg Allergen

    Saker ShopRites is recalling pork and chicken empanadas because they contain egg, a known allergen, which is not listed on the label. No injuries have been reported.

    Product
    Saker Shoprites Inc — Saker ShopRites, Inc. Recalls Empanadas due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state