The Recall Desk

Hazard

Class I recalls

464 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all class i recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

251–275 of 464

  • CriticalFDA (Drugs)·D-0613-2025·2025-09-10

    Health care antiseptic recalled over contamination with Burkholderia cepacia bacteria

    DermaRite PeriGiene Health Care Antiseptic containing chloroxylenol 0.5% is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.

    Product
    PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2430-2025·2025-09-10

    FXD Curve access systems recalled over ventilation-related air embolism risk

    Boston Scientific is recalling WATCHMAN FXD Curve Access Sys Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2436-2025·2025-09-10

    TruSteer transseptal access systems recalled over higher air embolism risk

    Boston Scientific is recalling WATCHMAN TruSteer Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0628-2025·2025-09-10

    Sodium chloride injection containers recalled over presence of particulate matter

    B. Braun 0.9% Sodium Chloride Injection USP in 1000 mL containers, lot V3K770, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 47,148 containers are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2448-2025·2025-09-10

    Dexcom G7 watchOS app recalled because sensor failure alerts are missing

    The Dexcom G7 CGM watchOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2449-2025·2025-09-10

    Dexcom ONE+ Android app recalled over missing sensor failure alerts

    The Dexcom ONE+ Android CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 41,629 units are affected.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2450-2025·2025-09-10

    Dexcom ONE+ iOS app recalled because sensor failed alerts do not appear

    The Dexcom ONE+ iOS CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 39,309 units are affected.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2433-2025·2025-09-10

    TruSeal ANT access systems recalled over air embolism risk without controlled ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access System ANT after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·H-0527-2025·2025-09-03

    Paneer cheese recalled over potential Listeria monocytogenes contamination in foodservice bags

    Paneer Cheese in 5 lb vacuum-sealed bags, lot 2517061, distributed for foodservice, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.

    Product
    Paneer Cheese, Net Wt. 30 lbs., packaged in 5 lb. vacuum-sealed plastic bags with lot code 2517061, packed 6 bags per white cardboard case with packed on date 6-18-25, distributed for food service only
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-2343-2025·2025-09-03

    Insulin pumps recalled over malfunction that stops insulin delivery and alerts

    Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0528-2025·2025-09-03

    Grass-fed pepper jack cheese recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op and Copia Collective 100% Grass-Fed Pepper Jack Cheese, lot 251661, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.

    Product
    1) Middlefield Original Cheese Co-op 100% Grass-Fed Pepper Jack Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. loaves, packaged in plastic with lot code 251661 2) Copia Collective 100% Grass-Fed Pepper Jack Cheese, 8 oz. individual units, packaged in plastic with lot c
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-2460-2025·2025-09-03

    Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots

    Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.

    Product
    Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0529-2025·2025-09-03

    Horseradish flavored cheese recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Horseradish Flavored Cheese, 8 oz, lot 2524061, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.

    Product
    Middlefield Original Cheese Co-op Horseradish Flavored Cheese, 8 oz. individual units, packaged in plastic with lot code 2524061
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·H-0530-2025·2025-09-03

    Monterey jack and farmers cheese recalled for possible Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Monterey Jack and Farmers Cheese are recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I. 640 pounds are affected.

    Product
    1) Middlefield Original Cheese Co-op Monterey Jack Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. blocks, packaged in plastic 2) Middlefield Original Cheese Co-op Farmers Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. blocks, packaged in plastic
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·H-0538-2025·2025-09-03

    Freeze dried organic mango powder recalled over potential Salmonella contamination

    Organic Mango Freeze Dried Powder in 15-kilogram bulk boxes is recalled for potential Salmonella contamination. The FDA classified the action as Class I, its most serious category.

    Product
    Organic Mango Freeze Dried Powder, Bulk, 15-kilogram boxes (2 packs of 7.5 kilograms in a carton box), 7.5kg packaged in multi-wall kraft paper boxes with inner food-grade polyethylene liner, Store in a cool, dry place away from direct sunlight; keep sealed until use
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0512-2025·2025-08-27

    Cheese bread recalled over undeclared egg absent from Contains statement

    Hillside Orchard Farms Cheese Bread, 23 oz, is recalled for undeclared egg. The FDA classified the action as Class I, its most serious category.

    Product
    Cheese Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY & WHEAT. HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·H-0509-2025·2025-08-27

    Fresh blackberry bread recalled because egg is not declared on label

    Hillside Orchard Farms Fresh Blackberry Bread, 23 oz, is recalled for undeclared egg. The FDA classified the action as Class I, its most serious category.

    Product
    Fresh Blackberry Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY, & WHEAT HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·H-0507-2025·2025-08-27

    Apple fritters recalled because egg is not declared on the label

    Hillside Orchard Farms Apple Fritters, 7 oz, are recalled for undeclared egg. The FDA classified the action as Class I, its most serious category.

    Product
    Apple Fritter Contains: Wheat, Soy and Milk Made By: Hillside Orchard Farms 105 Mitcham Circle Tiger, GA 30576
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·H-0514-2025·2025-08-27

    Cinnamon pecan fritters recalled because egg is missing from allergen labeling

    Hillside Orchard Farms Cinnamon Pecan Fritters, 7 oz, are recalled for undeclared egg. The FDA classified the action as Class I, its most serious category.

    Product
    Cinnamon Pecan Fritters Net Weight 7 oz (198g) CONTIANS: Wheat, Soybeans, Milk & Pecans Made By: Hillside Orchard Farms 105 Mitcham Circle Tiger, GA 30576
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·H-0506-2025·2025-08-27

    Fresh apple bread recalled over undeclared egg not listed on label

    Hillside Orchard Farms Fresh Apple Bread, 23 oz, is recalled for undeclared egg. The FDA classified the action as Class I, its most serious category.

    Product
    Fresh Apple Bread Net Wt 23 oz (652g) CONTAINS: MILK, SOY, & WHEAT HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-2327-2025·2025-08-27

    RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification

    RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.

    Product
    RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0513-2025·2025-08-27

    Cinnamon pecan bread recalled because egg is undeclared on the package

    Hillside Orchard Farms Cinnamon Pecan Bread, 23 oz, is recalled for undeclared egg. The FDA classified the action as Class I, its most serious category.

    Product
    Cinnamon Pecan Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY & WHEAT. HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576
    Category
    Food
    Distribution
    5 states