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.

1976–2000 of 7439

  • CriticalFDA (Food)·F-1461-2019·2019-06-26

    Maine Wild Blueberry Company Recalls Frozen Wild Blueberries Due to Listeria

    Maine Wild Blueberry Company is recalling 30-lb cases of frozen wild blueberries after internal sampling detected Listeria monocytogenes. The product was not distributed to consumers.

    Product
    30 Lbs IQF Wild Blueberries, Keep Frozen -10*C
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1759-2019·2019-06-26

    Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is voluntarily recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube.

    Product
    Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1529-2019·2019-06-26

    Mothers' Milk Bank at Austin Recalls Pasteurized Donor Human Breast Milk

    Mothers' Milk Bank at Austin is recalling 54 bottles of pasteurized donor human breast milk due to a positive microbiological culture for Bacillus cereus.

    Product
    Pasteurized donor human breast milk, Pool 9029, Batch 1 packaged in 3 ounce (90 cc) plastic bottles
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1398-2019·2019-06-19

    Heritage Pharmaceuticals Recalls Amikacin Sulfate Injection Due to Microbial Growth

    Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection vials because microbial growth was detected in a sub-lot. The affected product is distributed nationwide in the USA.

    Product
    AMIKACIN SULFATE — AMIKACIN SULFATE (AMIKACIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1344-2019·2019-06-19

    Aphrodisiac Platinum 40000 Recalled for Unapproved Sildenafil Contamination

    Select Distributions LLC is recalling Aphrodisiac Platinum 40000 because FDA analysis found the product is tainted with sildenafil and was marketed without an approved NDA/ANDA.

    Product
    Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Food)·F-1438-2019·2019-06-12

    Icco Cheese Co Recalls Gia Russa Bread Crumbs for Undeclared Allergens

    Icco Cheese Co Inc is recalling Gia Russa Whole Grain Italian Seasoned Bread Crumbs because the product contains undeclared walnuts and pecans.

    Product
    Gia Russa Whole Grain Italian Seasoned Bread Crumbs in 10 Oz Paperboard Canisters
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·067-2019·2019-06-09

    Taylor Farms Recalls Bacon Quiche for Undeclared Egg Allergen

    Taylor Farms Illinois is recalling 51 pounds of Jarlsberg and bacon quiche because the label failed to list eggs, a known allergen.

    Product
    Taylor Farms Illinois, Inc — Taylor Farms Illinois, Inc. Recalls Bacon Quiche Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-1443-2019·2019-06-05

    Laxmi Brand Dried Apricots Recalled for Undeclared Sulfites

    House of Spices India, Inc. is recalling Laxmi Brand Dried Apricots because the product contains elevated levels of undeclared sulfites.

    Product
    Laxmi Brand Dried Apricot 7 oz (200g) Plastic Pouch UPC Code: 2324617054
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1321-2019·2019-06-05

    Stiff Boy LLC Recalls The Beast Due to Undeclared Sildenafil

    Stiff Boy LLC is recalling The Beast because FDA analysis found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.

    Product
    The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1403-2019·2019-05-29

    Great American Marketing Recalls Turkey Pepper Jack Sub Sandwiches

    Great American Marketing Company is recalling Turkey Pepper Jack 6" Sub Sandwiches in Texas due to potential Listeria monocytogenes contamination.

    Product
    Turkey Pepper Jack 6" Sub Sandwich with Jalapeno Ranch Dressing 5.5 OZ.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1396-2019·2019-05-29

    Life Rising Recalls HoliCare Metabolism Cleansing Tablets Due to High Lead Levels

    Life Rising Corporation is recalling 52 bottles of HoliCare Metabolism Cleansing tablets because they contain high levels of lead. The products were sold locally in the Chicago area and via mail order.

    Product
    HoliCare Metabolism Cleansing (MET-CLS) tablets, 60 count bottle
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1422-2019·2019-05-29

    Mecox Bay Dairy Sunrise Raw Milk Cheese Recalled for Listeria

    Mecox Bay Dairy is recalling Sunrise Raw Milk Cheese after New York State sampling detected Listeria monocytogenes. The product was distributed in New York and Chicago.

    Product
    Mecox Bay Dairy Sunrise Raw Milk Cheese in plastic wrap code L 2148 Size Range between .25 lb to 3 lb portions of a 3 lb wheel.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1394-2019·2019-05-29

    Life Rising Holder-W Holder Warmer capsules recalled for high lead levels

    Life Rising Corporation is recalling Holder-W Holder Warmer capsules due to high lead levels. The products were sold locally in the Chicago area and via mail order.

    Product
    Life Rising Holder-W Holder Warmer capsules, 54 count bottle
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-1292-2019·2019-05-22

    Titanium 4000 capsules recalled for undeclared sildenafil and tadalafil

    D.B.P. Distribution is recalling Titanium 4000 capsules because they contain undeclared sildenafil and tadalafil and were marketed without an approved NDA or ANDA.

    Product
    Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1275-2019·2019-05-22

    Ethicon Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1340-2019·2019-05-22

    Schiff Foods Recalls Jalapeno Powder Due to Salmonella Risk

    Schiff Foods Products is recalling 50 lb. boxes of Jalapeno Powder because the product was found to contain Salmonella. The recall covers domestic and international distribution.

    Product
    Schiff Food, Jalapeno Powder, 50 lb. box
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1273-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1277-2019·2019-05-15

    Alvogen Recalls Fentanyl Transdermal Systems Due to Product Mix-Up

    Alvogen is recalling Fentanyl Transdermal Systems because a customer reported a carton labeled 12 mcg/h contained 50 mcg/h patches.

    Product
    FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1338-2019·2019-05-15

    Caito Foods Recalls Fresh Cut Melons for Salmonella Carrau Risk

    Caito Foods LLC is recalling fresh cut watermelon, honeydew, cantaloupe, and mixed fruit due to potential Salmonella Carrau contamination.

    Product
    Fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons.
    Category
    Food
    Distribution
    0 states