The Recall Desk

Hazard

Class I recalls

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

What the numbers show

Total
702
Critical
345
Severe
343
Most recent
2026-07-31

Of the 702 class i recalls we have scored against our rubric, 345 (49%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 343 (49%) are Severe.

Which agencies issued them

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.

476–500 of 702

  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2459-2025·2025-09-10

    IDM-ARLITE-R wheelchair controls recalled over unintended movement on power-up

    IDM-ARLITE-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 25 units are affected.

    Product
    IDM-ARLITE-R. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2456-2025·2025-09-10

    IDM-MICRO-R wheelchair controls recalled over unintended movement on power-up

    IDM-MICRO-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.

    Product
    IDM-MICRO-R. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2332-2025·2025-09-10

    Novum IQ large volume pumps recalled over software anomalies causing blank screens

    Baxter is issuing an urgent correction for Novum IQ Large Volume Pumps over software anomalies that may result in a blank Run screen. 43,922 units are affected.

    Product
    Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2447-2025·2025-09-10

    Dexcom G7 iOS app recalled because sensor failure alerts do not appear

    The Dexcom G7 CGM iOS 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 iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0610-2025·2025-09-10

    Antiseptic lotion soap recalled over contamination with Burkholderia cepacia

    DermaRite DermaKleen Health Care Antiseptic Lotion Soap is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 11,321 bag-in-boxes are affected.

    Product
    DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    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 (Devices)·Z-2428-2025·2025-09-10

    Transseptal access systems recalled over higher air embolism risk without controlled ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. 340,185 units are affected.

    Product
    WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; 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 (Devices)·Z-2455-2025·2025-09-10

    Multi Joystick wheelchair controls recalled over unintended movement at power-up

    Multi Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.

    Product
    Multi Joystick R-net. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2429-2025·2025-09-10

    FXD Curve access systems recalled over air embolism risk during transseptal procedures

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

    Product
    WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; 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-2458-2025·2025-09-10

    All-round Joystick Light controls recalled over unintended wheelchair movement at power-up

    All-round Joystick R-net Light wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.

    Product
    All-round Joystick R-net Light. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2481-2025·2025-09-10

    Left heart vent catheters 10FR recalled because they may not retain shape

    DLP Left Heart Vent Catheters, model 12110, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 41,200 units are affected.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2446-2025·2025-09-10

    Glucose monitor apps recalled because sensor failed alerts do not appear

    Dexcom G7 and ONE+ CGM apps are recalled because the app does not give the expected Sensor Failed alert, instead silently ending the session. The FDA classified the action as Class I. 532,821 units are affected.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0612-2025·2025-09-10

    Antimicrobial foam soap recalled over contamination with Burkholderia cepacia

    DermaRite KleenFoam Antimicrobial Foam Soap with Aloe Vera is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 6,973 cartridges are affected.

    Product
    KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0627-2025·2025-09-10

    Lactated Ringer's injection containers recalled over presence of particulate matter

    B. Braun Lactated Ringer's Injection USP in 1000 mL containers, lot J4S807, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 46,032 containers are affected.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2426-2025·2025-09-10

    TruSeal single access systems recalled over transseptal air ingress risk

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

    Product
    WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; 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 (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 (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-2434-2025·2025-09-10

    FXD Curve single access systems recalled over air embolism likelihood

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

    Product
    WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; 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-2427-2025·2025-09-10

    TruSeal double access systems recalled over air embolism risk under sedation

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

    Product
    WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; 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-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…
    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 (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