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.

1401–1425 of 7451

  • CriticalFDA (Devices)·Z-0599-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0172-2021·2020-12-23

    Holiday Cookie Platter Recalled for Undeclared Pecans

    George DeLallo Co. is recalling Holiday Cookie Platters due to undeclared pecans, a major food allergen.

    Product
    Holiday Cookie Platter packaged in plastic container 20 OZ (1.25 LB) 567g. UPC 41415 88690
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-0168-2021·2020-12-23

    AvKare Recalls Trazodone Hydrochloride Tablets Due to Sildenafil Packaging Mix-Up

    AvKare Inc. is recalling 14,368 bottles of Trazodone Hydrochloride Tablets 100 mg because they were inadvertently packaged with sildenafil.

    Product
    TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0173-2021·2020-12-16

    Hy-Vee Grill Ready Veggie Mix Recalled for Listeria

    Hy-Vee is recalling Short Cuts Grill Ready Veggie Mix because an ingredient tested positive for Listeria monocytogenes.

    Product
    Hy-Vee, Short Cuts, Grill Ready Veggie Mix sold by weight in approximate 1 lb containers, Distributed by Hy-Vee Inc, West Des Moines, IA UPC 272104 XXXXXX
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0174-2021·2020-12-16

    Hy-Vee Pot Roast Mix Recalled for Listeria Contamination

    Hy-Vee is recalling Short Cuts Pot Roast Mix because an ingredient tested positive for Listeria monocytogenes. Consumers should discard the product.

    Product
    Hy-Vee, Short Cuts, Pot Roast Mix sold by weight in approximate 1 lb containers, Distributed by Hy-Vee Inc, West Des Moines, IA UPC 272083 XXXXXX
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0144-2021·2020-12-09

    Dole Organic Romaine Hearts Recalled Due to E. coli Contamination

    Dole Fresh Vegetables Inc. is recalling specific lots of Organic Romaine Hearts because pathogenic non-O157 E. coli STEC was found during routine sampling.

    Product
    Dole" Organic Romaine Hearts 3pk Organic Biologique) (UPC 0-71430-90061-1), Wild Harvest Organic Romaine Hearts, Net Wt 12 oz. (UPC 7-11535-50201-2),
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Drugs)·D-0111-2021·2020-12-09

    Lohxa Recalls Chlorhexidine Gluconate Oral Rinse Due to Bacterial Contamination

    Lohxa LLC is recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12%, due to contamination with Burkholderia lata bacteria.

    Product
    Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0118-2021·2020-12-09

    MPM Medical Recalls REGENECARE HA Topical Anesthetic Due to Bacteria

    MPM Medical LLC is recalling REGENECARE HA topical anesthetic hydrogel because it was found to be contaminated with Burkholderia cepacia bacteria.

    Product
    REGENECARE HA — REGENECARE HA (LIDOCAINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0138-2021·2020-12-02

    Fresh Express Kit Caesar Supreme Recalled for E. coli O26 Contamination

    Fresh Express is recalling Kit Caesar Supreme salad kits due to potential contamination with Escherichia coli STEC O26.

    Product
    FRESH EXPRESS KIT CAESAR SUPREME, Romaine Lettuce, Creamy Caesar Dressing, Italian Artisan Cheeses, Savory Garlic Croutons, Total Net WT. 10.5oz (298g)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0133-2021·2020-12-02

    Whole Foods Chicken Rustico Romano Chef Plate Recalled for Undeclared Egg

    Whole Foods Market is recalling Chicken Rustico Romano Chef Plates due to potential undeclared egg. The product was distributed in five states and Washington, D.C.

    Product
    Chicken Rustico Romano Chef Plate with Mac & Cheese and Broccoli, packaged in clear plastic container with printed label product code begins with 241442
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0132-2021·2020-12-02

    Whole Foods Recalls Fried Chicken Meals for Potential Undeclared Egg

    Whole Foods Market is recalling Fried Chicken Meals with Mac & Cheese in five states and D.C. due to a potential undeclared egg allergen.

    Product
    Fried Chicken Meal with Mac & Cheese, packaged in clear plastic container with printed label product code begins with 247257; Fried Chicken Meal with Mac & Cheese, packaged on hot bar product code begins with 237444
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0130-2021·2020-12-02

    Whole Foods Market Recalls Macaroni and Cheese for Undeclared Egg

    Whole Foods Market is recalling specific macaroni and cheese products due to a potential undeclared egg allergen. Consumers in five states and D.C. should check their products.

    Product
    Macaroni & Cheese, chef s case; Macaroni & Cheese, packaged in clear plastic container; Macaroni & Cheese, online and catering product code begins with 286501, 263608, 114449, or 109866
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0135-2021·2020-12-02

    Whole Foods Recalls BBQ Turkey Meatballs for Undeclared Egg

    Whole Foods Market is recalling BBQ Turkey Meatballs Chef Plates due to a potential undeclared egg allergen. The product was distributed in Maryland, New Jersey, Pennsylvania, Virginia, and Washington, D.C.

    Product
    BBQ Turkey Meatballs Chef Plate with Mac & Cheese and Green Beans, packaged in clear plastic container with printed label product code begins with 241464
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0131-2021·2020-12-02

    Whole Foods Recalls Rotisserie Chicken Meals for Undeclared Egg

    Whole Foods Market is recalling Rotisserie Chicken Meals with Mac & Cheese and Broccoli due to a potential undeclared egg allergen. The recall affects specific product codes sold in the Mid-Atlantic region.

    Product
    Rotisserie Chicken Meals with Mac & Cheese and Broccoli, packaged in clear plastic container with printed label product code begins with 261596 261580, 261590, 261601, 261608, or 261616
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0124-2021·2020-11-25

    National Food Trading Recalls Frozen Green Beans for Listeria Risk

    National Food Trading Corporation is recalling 28,262 lbs of frozen French cut green beans due to possible Listeria monocytogenes contamination.

    Product
    Frozen French Cut Green Beans. Packaged in 20.5 lb boxes. Expiration date 11/25/2022
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0096-2021·2020-11-18

    IncredibleStoneCrab Mustard Sauce Recalled for Undeclared Allergens

    Incredible Fish is recalling 181 containers of IncredibleStoneCrab Mustard Sauce due to undeclared fish, egg, and milk allergens.

    Product
    IncredibleStoneCrab, Mustard Sauce, 8 oz. plastic container, Distributed by: IncredibleStoneCrab,
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0102-2021·2020-11-18

    Meijer Fruit Tray With Dip Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh From Meijer Fruit Tray with Dip due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER FRUIT TRAY WITH DIP, 49oz Clear plastic container, UPC 219248610449
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0108-2021·2020-11-18

    Meijer Berry Explosion Cups Recalled for Potential Salmonella Risk

    Meijer is recalling 1,280 units of Fresh from Meijer Berry Explosion Cups due to a potential risk of Salmonella. The products were sold in six states.

    Product
    FRESH FROM MEIJER GS BERRY EXPLOSION CUP 6 OZ, 6oz Clear plastic container, UPC 219717302295
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0115-2021·2020-11-18

    Starwest Botanicals Recalls Organic Elderberry Due to Salmonella Risk

    Starwest Botanicals is recalling organic elderberry because a customer test detected Salmonella. The product was distributed nationwide and to two Canadian customers.

    Product
    Elderberry Whole Organic; Sambucus Nigra; Origin: Croatia Distributed in boxes with plastic liners. Various sizes Bulk UPC 7 67963 07314 3, Item # 209290-00 Starwest Botanicals,Inc. 161 Main Street, Sacramento, CA 95838 Certified Organic
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0127-2021·2020-11-18

    J&O Mixed Veggie Cup Recalled for Undeclared Egg Allergen

    Russ Davis Wholesale is recalling J&O Mixed Veggie Cups with Dip because they contain undeclared egg. The product was sold in five states.

    Product
    J&O Mixed Veggie Cup with Dip, Net Weight 5.0 oz. (128 g), UPC 95631-85818. Mfg By: RDW, Pueblo CO 81001
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0107-2021·2020-11-18

    Meijer Strawberry and Pineapple Cup Recalled for Salmonella Risk

    Meijer is recalling 1,300 units of Fresh from Meijer Strawberry/Pineapple Cups due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER GS STRAWBERRY/PINEAPPLE CUP 6 OZ, 6oz Clear plastic container, UPC 219711302291
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0098-2021·2020-11-18

    Meijer Recalls Cantaloupe and Honeydew Slices Due to Salmonella Risk

    Meijer is recalling 24oz containers of Fresh from Meijer Cantaloupe and Honeydew Slices due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER CANTALOUPE AND HONEYDEW SLICES, 24oz Clear plastic container, UPC 220219600079
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0103-2021·2020-11-18

    Meijer Fruit Tray Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh From Meijer Fruit Trays due to a potential risk of Salmonella. The product was sold in six states between September 26 and October 5.

    Product
    FRESH FROM MEIJER FRUIT TRAY, 49oz Clear plastic container, UPC 219214610008
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0097-2021·2020-11-18

    Meijer Cantaloupe Chunks Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh from Meijer Cantaloupe Chunks due to a potential risk of Salmonella. The products were sold in six states.

    Product
    FRESH FROM MEIJER CANTALOUPE CHUNKS LARGE BOWL, 32oz Clear plastic container, UPC 219323109721. FRESH FROM MEIJER CANTALOUPE CHUNKS SMALL BOWL, 16oz Clear plastic container, UPC 220196109725. FRESH FROM MEIJER CANTALOUPE CHUNKS KOSHER - LG, 32oz Clear plastic container, UPC…
    Category
    Food
    Distribution
    6 states