The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. The hazard can cause serious injury or death. 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.

1626–1650 of 7451

  • CriticalFDA (Food)·F-0843-2020·2020-03-25

    Vita Wild Herring in Wine Sauce Recalled for Undeclared Milk

    Vita Food Products, Inc. is recalling 8,370 units of Vita Wild Herring in Wine Sauce due to undeclared milk, a major allergen.

    Product
    Vita Wild Herring in Wine Sauce 32oz plastic jar, UPC 22635 40011, 6 jars per case Ready to Eat Keep Refrigerated
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-0829-2020·2020-03-18

    Shearer's Yellow Tortilla Chips Recalled for Undeclared Milk

    Shearer's Snacks is recalling specific lots of Yellow tortilla chips due to undeclared milk. The product was shipped to two distributors and is fully accounted for.

    Product
    Shearer's Yellow tortilla chips, round Mini and Restaurant sizes, packaged in clear film pillow bags in the following weights: 1oz (100 count per case), 1.5oz (72 count per case), 2oz (60 count per case), and a bulk case16oz bags (10 count per case)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1442-2020·2020-03-18

    CME BodyGuard Microset Infusion Sets Recalled for Fluid Under-Delivery

    CME America is recalling BodyGuard Microset infusion sets because they may under-deliver fluids when used with specific infusion pump systems.

    Product
    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
    Category
    Medical Device
    Distribution
    4 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-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 (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 (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…
    Category
    Medical Device
    Distribution
    0 states
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • 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…
    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…
    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…
    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-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…
    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…
    Category
    Medical Device
    Distribution
    0 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-0701-2020·2020-02-19

    ADM Milling Recalls Sir Lancelot Flour Due to E. coli O26 Risk

    ADM Milling is recalling 300 bags of Sir Lancelot HG Flour because it may be contaminated with E. coli O26. The product was distributed to 13 states.

    Product
    Sir Lancelot HG Flour Unbl, Enr, Mt / Product Code: 802203 in 50# bags
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0703-2020·2020-02-19

    ADM Milling Recalls Bulk Flour Due to E. coli O26 Contamination

    ADM Milling is voluntarily recalling bulk flour distributed to 13 states due to potential E. coli O26 contamination. The recall was initiated in September 2019 and terminated in September 2020.

    Product
    Bulk flour
    Category
    Food
    Distribution
    13 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-0685-2020·2020-02-19

    ADM Milling Recalls Bakers Corner Flour Due to E. coli O26 Risk

    ADM Milling is recalling 204,960 bags of Bakers Corner All Purpose Flour because it may be contaminated with E. coli O26.

    Product
    Bakers Corner All Purpose Flour in 5 lb. 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-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-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