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.

101–125 of 7436

  • CriticalFDA (Devices)·Z-1162-2026·2026-02-11

    HOT AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 150 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 8mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1163-2026·2026-02-11

    HOT AXIOS 20mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 588 units of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0460-2026·2026-02-11

    Organic black chia seed recalled over potential Salmonella contamination

    Tradin Organics USA is recalling 54,680 lbs of Organic Chia Seed Black over potential contamination with Salmonella.

    Product
    Organic Chia Seed Black Origin: PARAGUAY Net weight: 55.12 LBS Produced for: Tradin Organics USA, LLC, Aptos
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1159-2026·2026-02-11

    AXIOS 6mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0332-2026·2026-02-11

    Rheumacare capsules recalled after the product was found to contain lead

    Handelnine Global is recalling four bottles of Rheumacare capsules after the product was found to contain lead.

    Product
    Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Food)·H-0499-2026·2026-02-11

    Spice cake mix recalled over an undeclared milk allergen

    B.C. Williams Bakery Service is recalling 51 bags of Spice Cake Mix, sold in 50 lb bags, over an undeclared milk allergen.

    Product
    Spice Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1158-2026·2026-02-11

    AXIOS stents recalled over deployment and expansion problems during placement

    Boston Scientific is recalling 557 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 20mm x 10mm, after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0481-2026·2026-02-11

    Bread crumbs recalled over undeclared egg and milk allergens

    VH Foods is recalling 4,497 packages of Outside The Breadbox brand Bread Crumbs, 8 oz, over undeclared egg and milk.

    Product
    Bread Crumbs, Outside The Breadbox brand, net wt. 8 oz, UPC 873799001554. Product is packaged in a clear stand up pouch. Intended use baking. Condition/Shelf Life shelf stable, 180 days. Firm name Outside The Breadbox, 2027 W Colorado Ave. Colorado Springs, CO.
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Drugs)·D-0304-2026·2026-02-11

    Male supplement capsules recalled after FDA analysis found tadalafil

    Green Lumber Holdings is recalling Green Lumber Natural Fuel For Men capsules because FDA analysis found the product to contain tadalafil, and it is marketed without an approved application.

    Product
    Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0501-2026·2026-02-11

    Swiss chocolate cake mix recalled over an undeclared milk allergen

    B.C. Williams Bakery Service is recalling 95 bags of Swiss Chocolate Cake Mix, sold in 50 lb bags, over an undeclared milk allergen.

    Product
    Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1161-2026·2026-02-11

    HOT AXIOS stents recalled over deployment and expansion problems

    Boston Scientific is recalling 266 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0500-2026·2026-02-11

    Bread and roll mix recalled over an undeclared milk allergen

    B.C. Williams Bakery Service is recalling 720 bags of Bread and Roll Mix, sold in 50 lb bags, over an undeclared milk allergen.

    Product
    Bread and Roll Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1160-2026·2026-02-11

    AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 59 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0433-2026·2026-02-04

    Super greens powder tubs recalled over possible Salmonella Typhimurium contamination

    Superfoods, Inc. is recalling Live it Up brand Super Greens powder, net weight 8.5oz, because the products may be contaminated with Salmonella Typhimurium.

    Product
    Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30 day supply; NET WT. 8.5OZ (240G); Manufactured for Superfoods, Inc.; UPC: 860013190804 b.) Live it Up brand Super Gr
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1115-2026·2026-02-04

    Broselow Rainbow Tape 7700RE recalled over potentially harmful dosing errors

    SunMed Holdings is recalling 20,583 units of the Broselow Pediatric Emergency Rainbow Tape, model 7700RE, because it contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1114-2026·2026-02-04

    Pediatric emergency tapes recalled over potentially harmful drug dosing errors

    SunMed Holdings is recalling 95,300 units of the Broselow Pediatric Emergency Rainbow Tape because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1117-2026·2026-02-04

    Filled Broselow organizers recalled over potentially harmful dosing errors

    SunMed Holdings is recalling 89 units of the Filled Broselow Organizer, model 7730IALS, because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Comp
    Category
    Medical Device
    Distribution
    Distributed nationwide