The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

7151–7175 of 29119

  • SevereFDA (Food)·F-0589-2022·2022-02-02

    Fresh Express Parisienne Supreme Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Parisienne Supreme salad in 16oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers across 20 U.S. states and Canada.

    Product
    "Parisienne Supreme" (salad product) packed in 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0581-2022·2022-02-02

    Organic Herb Mix Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc's Organic Herb Mix salad product has been recalled due to potential Listeria monocytogenes contamination. The recall affects 6,137 cases distributed across multiple states and Canada.

    Product
    "Organic Herb Mix" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0559-2022·2022-02-02

    Fresh Express Garden Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling its "Garden" salad product in 12oz., 24oz., and 3lb. packages due to potential Listeria monocytogenes contamination. The recall affects approximately 181,969 cases distributed across 20 U.S. states and Canada.

    Product
    "Garden" (salad product) packed in 12oz., 24oz., and 3lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0528-2022·2022-02-02

    Baby Greens Salad Recalled Due to Potential Listeria Monocytogenes Contamination

    Fresh Express Inc is recalling 611 units of Baby Greens salad in 6oz packages due to potential Listeria monocytogenes contamination. The product was distributed to 110 domestic distributors across 20 states and Canada.

    Product
    "Baby Greens" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0392-2022·2022-02-02

    Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination

    Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 750 mg tablets due to detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The contamination resulted from manufacturing deviations.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0422-2022·2022-02-02

    Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0532-2022·2022-02-02

    Fresh Express Bacon Thousand Island Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Bacon Thousand Island salad in 9.4 oz packages due to potential Listeria monocytogenes contamination. The recall affects 9,116 cases distributed across multiple U.S. states and Canada.

    Product
    "Bacon Thousand Island" (salad product) packed in 9.4oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0411-2022·2022-02-02

    Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.

    Product
    Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0544-2022·2022-02-02

    Chopped Chipotle Cheddar Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling Chopped Chipotle Cheddar salad in 11.4oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Chopped Chipotle Cheddar" (salad product) packed in 11.4oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0538-2022·2022-02-02

    Fresh Express Chicken Caesar Bowl Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Chicken Caesar Bowl salads in 5.7oz and 5.75oz packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Chicken Caesar Bowl" (salad product) packed in 5.7oz. and 5.75oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0574-2022·2022-02-02

    Organic Baby Romaine Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling 1,105 cases of Organic Baby Romaine salad due to potential Listeria monocytogenes contamination. The product was distributed across 20 states and Canada.

    Product
    "Organic Baby Romaine" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0592-2022·2022-02-02

    Fresh Express Romaine Chopped Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Romaine Chopped salad in 32oz. and 2lb. packages due to potential Listeria monocytogenes contamination. The recall affects approximately 9,741 cases distributed across 20 U.S. states and Canada.

    Product
    "Romaine Chopped" (salad product) packed in 32oz. and 2lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0591-2022·2022-02-02

    Roma Sliced Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Roma Sliced salad products in 1.5lb. packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to domestic and Canadian distributors.

    Product
    "Roma Sliced" (salad product) packed in 1.5lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0493-2022·2022-02-02

    Trilogy Evo Ventilator Recalled for Foam Degradation Risk

    Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.

    Product
    Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adul
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-0610-2022·2022-02-02

    Twisted Chopped Greek Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Twisted Chopped Greek Caesar salad in 9.3oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Twisted Chopped Greek Caesar" (salad product) packed in 9.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0562-2022·2022-02-02

    Hearts of Romaine Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling Hearts of Romaine salad in 9oz., 10oz., and 18oz. packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to multiple states and Canada.

    Product
    "Hearts of Romaine" (salad product) packed in 9oz., 10oz., and 18oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0599-2022·2022-02-02

    Spinach & Bacon Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling 14,832 cases of "Spinach & Bacon" salad in 10.2oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian retailers.

    Product
    "Spinach & Bacon" (salad product) packed in 10.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0421-2022·2022-02-02

    Sterile Ophthalmic Solution Lacks Assurance of Sterility

    Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes distributed nationwide.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0394-2022·2022-02-02

    ALUM Concentrate IV Bags Recalled for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.

    Product
    ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0533-2022·2022-02-02

    Fresh Express Caesar Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Caesar salad products in multiple package sizes due to potential contamination with Listeria monocytogenes. The recall affects approximately 99,102 cases distributed across the United States and Canada.

    Product
    "Caesar" (salad product) packed in 9.8oz., 10.5oz., 11.3oz., 14.5oz., 19.5oz., and 22.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0560-2022·2022-02-02

    Green & Crisp Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Green & Crisp salad in 11oz packages due to potential Listeria monocytogenes contamination. The recall affects 26,695 cases distributed across multiple US states and Canada.

    Product
    "Green & Crisp" (salad product) packed in 11oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0395-2022·2022-02-02

    Lidocaine HCl Sterile Buffered Solution Recalled for Lack of Sterility Assurance

    Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.

    Product
    Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0494-2022·2022-02-02

    Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material

    Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.

    Product
    Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric t
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-0590-2022·2022-02-02

    Premium Romaine Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Premium Romaine salad products in 9oz. and 18oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 33,374 cases distributed to domestic and Canadian distributors.

    Product
    "Premium Romaine" (salad product) packed in 9oz. and 18oz. packages
    Category
    Food
    Distribution
    20 states