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.

4051–4075 of 4878

  • SevereFDA (Food)·F-0564-2022·2022-02-02

    Fresh Express Italian Balsamic Kit Salad Recall for Listeria Risk

    Fresh Express Inc is recalling Italian Balsamic Kit salad products due to potential Listeria monocytogenes contamination. The affected 10.5 oz packages were distributed to wholesalers in 20 U.S. states and Canada.

    Product
    "Italian Balsamic Kit" (salad product) packed in 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0575-2022·2022-02-02

    Organic Baby Spinach Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Organic Baby Spinach in 5oz., 10oz., and 16oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to multiple domestic and Canadian distributors.

    Product
    "Organic Baby Spinach" (salad product) packed in 5oz., 10oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0557-2022·2022-02-02

    Fancy Greens Salad Recalled Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Fancy Greens salad in 7oz packages due to potential Listeria monocytogenes contamination. The affected products were distributed to retailers across 20 U.S. states and Canada.

    Product
    "Fancy Greens" (salad product) packed in 7oz. 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-0418-2022·2022-02-02

    Phenylephrine Injection Recall Due to Sterility Assurance Concerns

    Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.

    Product
    PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0588-2022·2022-02-02

    Fresh Express Pear Gorgonzola Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Pear Gorgonzola salad in 6.7 oz. packages due to potential contamination with Listeria monocytogenes. The recall affects products distributed to multiple domestic and Canadian distributors.

    Product
    "Pear Gorgonzola" (salad product) packed in 6.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0597-2022·2022-02-02

    Fresh Express Spinach Recalled for Potential Listeria Contamination

    Fresh Express Inc has recalled "Spinach" salad products in 8oz., 10oz., and 16oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 130,592 cases distributed to domestic and foreign distributors.

    Product
    "Spinach" (salad product) packed in 8oz., 10oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0537-2022·2022-02-02

    Chef Salad Bowl Products Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Chef Salad Bowl products due to potential contamination with Listeria monocytogenes. The recall affects 6.2oz packages distributed to domestic and Canadian distributors.

    Product
    "Chef Salad Bowl" (salad product) packed in 6.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0605-2022·2022-02-02

    Sweet Hearts Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Sweet Hearts salad in 9oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed to domestic and Canadian distributors.

    Product
    "Sweet Hearts" (salad product) packed in 9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0600-2022·2022-02-02

    Fresh Express Spring Mix Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Spring Mix salad in multiple package sizes due to potential Listeria monocytogenes contamination. The product was distributed across the United States and Canada.

    Product
    "Spring Mix" (salad product) packed in 5oz., 10oz., 11oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0569-2022·2022-02-02

    Fresh Express Lettuce Trio Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Lettuce Trio" salad in 9oz. packages due to potential Listeria monocytogenes contamination. The product was distributed across the United States and Canada.

    Product
    "Lettuce Trio" (salad product) packed in 9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0413-2022·2022-02-02

    Phenol Injection Solution Recall Due to Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.

    Product
    Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0531-2022·2022-02-02

    Fresh Express Bacon & Blue Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Bacon & Blue" salad products (10.8 oz and 10.9 oz packages) distributed across 20 U.S. states and Canada due to potential Listeria monocytogenes contamination.

    Product
    "Bacon & Blue" (salad product) packed in 10.8oz. and 10.9oz. packages
    Category
    Food
    Distribution
    20 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
  • SevereFDA (Drugs)·D-0402-2022·2022-02-02

    Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance

    Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.

    Product
    Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
    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-0587-2022·2022-02-02

    Organic Sweet Lettuce Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Sweet Lettuce salad products in 5oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed to domestic and Canadian distributors.

    Product
    "Organic Sweet Lettuce" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • 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-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-0552-2022·2022-02-02

    Chopped Sunflower Bacon Salad Recall for Listeria Contamination

    Fresh Express Inc is recalling Chopped Sunflower Bacon salad products (13.8oz and 22.3oz packages) due to potential Listeria monocytogenes contamination. The recall affects domestic and Canadian distributors across multiple states.

    Product
    "Chopped Sunflower Bacon" (salad product) packed in 13.8oz. and 22.3oz. packages
    Category
    Food
    Distribution
    20 states
  • 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-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-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 (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