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.

14751–14775 of 29202

  • SevereFDA (Devices)·Z-0582-2018·2018-02-28

    Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk

    Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0437-2018·2018-02-28

    Pharmedium Recalls Morphine Sulfate in 5% Dextrose Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Morphine Sulfate in 5% Dextrose in all strengths and packaging due to a lack of sterility assurance.

    Product
    Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2018·2018-02-28

    Pharmedium Recalls Ropivacaine HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Ropivacaine HCl Injection in all strengths and packaging due to a lack of sterility assurance.

    Product
    Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0488-2018·2018-02-28

    FDA Recalls Estradiol USP for Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Estradiol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.

    Product
    Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0533-2018·2018-02-28

    FDA Recalls Vardenafil HCl for Prescription Compounding Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Vardenafil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.

    Product
    Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0638-2018·2018-02-28

    ROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors

    Zimmer Biomet is recalling 16 ROSA Brain 3.0 Stereotaxic instruments because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0455-2018·2018-02-28

    Pharmedium Recalls Lidocaine HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Lidocaine HCl in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.

    Product
    Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0641-2018·2018-02-28

    Allen Medical Bow Frame Recalled Due to Potential Base Cracking

    Allen Medical Systems is recalling 161 Bow Frame Model A-70800 surgical platforms because the base may crack when patients are transferred onto the device.

    Product
    Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2018·2018-02-28

    Pharmedium Recalls Dexamethasone Sodium Phosphate Infusions Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, doses, and packaging due to a lack of sterility assurance.

    Product
    Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0438-2018·2018-02-28

    Pharmedium Recalls Lidocaine HCl Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Lidocaine HCl due to a lack of sterility assurance. The recall covers products distributed nationwide in the U.S.

    Product
    Lidocaine HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2018·2018-02-28

    Pharmedium Recalls Esmolol HCl Due to Lack of Sterility Assurance

    Pharmedium Services, LLC is recalling Esmolol HCl in all strengths and packaging due to a lack of sterility assurance.

    Product
    Esmolol HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2018·2018-02-28

    Pharmedium Recalls Midazolam HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Midazolam HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0825-2018·2018-02-28

    National Frozen Foods Recalls Frozen Vegetable Blends Due to Listeria Risk

    National Frozen Foods Corporation is recalling specific lots of Monarch and Simplot Classic frozen vegetable blends due to potential Listeria monocytogenes contamination.

    Product
    IQF blend product sold as Not Ready To Eat (NRTE) product for use in foodservice or manufacturing applications. The product cases are labeled with instructions to cook product. -Monarch brand, IQF frozen Capri Vegetable Blend, Ingredients: Carrots, Green Beans, Yellow Squash…
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-0433-2018·2018-02-28

    Pharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl Injection due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0816-2018·2018-02-28

    Flexfrost Protein Ice Cream Recalled for Insufficient Pasteurization Monitoring

    Flexfrost is recalling Cinnamon Chai Protein Ice Cream because the Ohio Department of Agriculture found insufficient pasteurization monitoring measures.

    Product
    Flexfrost Protein Ice Cream Cinnamon Chai Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0469-2018·2018-02-28

    Pharmedium Recalls Nicardipine HCl Infusions Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Nicardipine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2018·2018-02-28

    Pharmedium Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Ephedrine Sulfate Injection due to a lack of sterility assurance.

    Product
    Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0439-2018·2018-02-28

    Pharmedium Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Fentanyl Citrate in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2018·2018-02-28

    Pharmedium Recalls All Nicardipine HCl Due to Sterility Assurance Issues

    Pharmedium Services, LLC is recalling all lots of Nicardipine HCl because the product lacks sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.

    Product
    Nicardipine HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0429-2018·2018-02-28

    Pharmedium Recalls Bupivacaine HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Bupivacaine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers 297 bags distributed nationwide.

    Product
    Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0432-2018·2018-02-28

    Pharmedium Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Ephedrine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.

    Product
    Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2018·2018-02-28

    Pharmedium Recalls Atropine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Atropine Sulfate Injection nationwide due to a lack of sterility assurance.

    Product
    Atropine Sulfate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0431-2018·2018-02-28

    Pharmedium Recalls Fentanyl and Bupivacaine Injections Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Fentanyl Citrate and Bupivacaine HCl injections due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide