The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

1601–1625 of 7439

  • CriticalFDA (Food)·F-0759-2020·2020-03-11

    Blendtopia Superfood Smoothie Kit Recalled for Listeria Contamination Risk

    Blendtopia is recalling Superfood Smoothie Kit Glow flavor pouches due to potential Listeria monocytogenes contamination. Consumers should stop using the product.

    Product
    Blendtopia Superfood Smoothie Kit Glow flavor, 7 oz flexible pouch
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-0760-2020·2020-03-11

    Blendtopia Superfood Smoothie Kit Recalled for Listeria Contamination

    Blendtopia is recalling Superfood Smoothie Kit Detox flavor pouches due to potential Listeria monocytogenes contamination. Consumers should stop using the product.

    Product
    Blendtopia Superfood Smoothie Kit Detox flavor, 7 oz flexible pouch
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-0755-2020·2020-03-04

    Nopalina Flax Seed Fiber Recalled for Salmonella Contamination

    Salud Natural Entrepreneur, Inc. is recalling Nopalina Flax Seed Fiber powder in 1 and 2 lb bags because FDA testing found Salmonella in the senna leaves powder ingredient.

    Product
    Nopalina Flax Seed Fiber in 1 and 2 lb bags, UPC 8 90523 00072 0 and 8 90523 00084 3
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0798-2020·2020-03-04

    Bakkavor Mushroom Barley Soup Recalled for Undeclared Milk Allergen

    Bakkavor Foods USA Inc. is recalling Chef's Recipe Mushroom Barley Soup because it contains undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    chef's recipe MUSHROOM BARLEY SOUP NET WT 16 OZ (1LB) 454g PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 UPC 1 61088 80363 0
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0756-2020·2020-03-04

    Nopalina Flax Seed Fiber Capsules Recalled for Salmonella Contamination

    Salud Natural Entrepreneur, Inc. is recalling Nopalina Flax Seed Fiber Capsules because FDA testing found Salmonella in the senna leaves powder ingredient.

    Product
    Nopalina Flax Seed Fiber Capsules, 120 count bottle, UPC 8 90523 00086 7
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0942-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriat
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0711-2020·2020-02-26

    Hungry Root Dairy Free Garlic Parmesan Sauce Recalled for Undeclared Cashews

    The Honest Stand is recalling Hungry Root Dairy Free Garlic Parmesan Sauce because it contains cashews that were not listed on the physical packaging.

    Product
    Hungry Root Dairy free Garlic Parm sauce, Packaged in 9 oz. polypropylene dip containers with lidding film and lid, packed in 24 count master cases. Distributed by Hungry Root Inc. NY, NY 10003
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0952-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.

    Product
    Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriat
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0947-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 15 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropri
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1135-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0950-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the app
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1133-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoca
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1136-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0694-2020·2020-02-19

    ADM Milling Recalls Flour Due to E. coli O26 Contamination

    ADM Milling is recalling 4,250 bags of Commander Flour because it may be contaminated with E. coli O26. The product was distributed to 13 states.

    Product
    Commander Flr BL ENR BR MT, Product Code 704260 in 50 lbs bags
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0691-2020·2020-02-19

    ADM Milling Recalls Best Baker's Flour Due to E. coli O26 Risk

    ADM Milling is recalling 5,000 bags of Best Baker's flour because of a potential E. coli O26 contamination. The recall covers 13 states.

    Product
    Best Baker's flour 50 lbs bags
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0696-2020·2020-02-19

    ADM Milling Recalls H & R All Purpose Flour Due to E. coli O26

    ADM Milling is recalling 1,900 bags of H & R All Purpose Flour because it may be contaminated with E. coli O26.

    Product
    H & R All Purpose Flour BL EN MT /Product Code: 706250 in 50 lbs bags
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0686-2020·2020-02-19

    King Arthur Flour Recalled Due to E. coli O26 Contamination Risk

    ADM Milling is recalling 762,720 bags of King Arthur All-purpose Flour due to a potential E. coli O26 contamination risk.

    Product
    King Arthur All-purpose Flour in 5 lb bag UPC 071012010509
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0690-2020·2020-02-19

    ADM Milling Recalls Balancer Flour Bags Due to E. coli O26 Risk

    ADM Milling is recalling 88,250 bags of Balancer flour because of a potential E. coli O26 contamination. The product was distributed across 13 states.

    Product
    Balancer flour 50 lbs bags
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0693-2020·2020-02-19

    ADM Milling Recalls Commander Flour Due to E. coli O26 Risk

    ADM Milling is voluntarily recalling 950 bags of Commander Flour because it may be contaminated with E. coli O26.

    Product
    Commander Flour, Product Code 704220 in 50 lbs bags
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Drugs)·D-0867-2020·2020-02-19

    RemedyRepack Recalls Ketorolac Tromethamine Injections Due to Particulate Matter

    RemedyRepack Inc. is recalling 75 vials of Ketorolac Tromethamine 30 mg/1mL injections distributed in Oklahoma and Louisiana due to the presence of small black particles.

    Product
    Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Food)·F-0702-2020·2020-02-19

    ADM Milling Recalls Springup Flour Due to E. coli O26 Risk

    ADM Milling is recalling 1,000 bags of Springup Flour because of a potential E. coli O26 contamination. The product was distributed to 13 states.

    Product
    Springup Flour Product Code 703220 in 50# bags
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Devices)·Z-1114-2020·2020-02-19

    Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems

    Teleflex Medical is recalling 127,293 Hudson RCI Comfort Flo Humidification Systems nationwide due to a potential risk of water flooding the column and entering the circuit during high-flow oxygen therapy.

    Product
    HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0687-2020·2020-02-19

    Robin Hood All-purpose Flour Recalled for E. coli O26 Contamination

    ADM Milling is recalling 62,400 bags of Robin Hood All-purpose Flour due to E. coli O26 contamination. The recall covers 13 states.

    Product
    Robin Hood All-purpose Flour in 5 lb bag UPC 051500180105
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0697-2020·2020-02-19

    ADM Milling Recalls Flour Due to E. coli O26 Contamination

    ADM Milling is voluntarily recalling 2,550 bags of H&R Flour because of potential E. coli O26 contamination. The recall covers products distributed to 12 states.

    Product
    H&R Flour, UNBL, EN, MT / Product Code 706220 in 50# bags
    Category
    Food
    Distribution
    13 states