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.

601–625 of 7486

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 (Food)·H-0574-2025·2025-09-03
Sprouted mat recalled after testing positive for Salmonella in packaged product
Deep Sprouted Mat, 16 oz, is recalled after the product tested positive for Salmonella. The FDA classified the action as Class I, its most serious category. 5,232 packets are affected.
Product
Deep Sprouted Mat 16 oz.
Category
Food
Distribution
5 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 (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…
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-0575-2025·2025-09-03
Sprouted moong recalled after testing positive for Salmonella in packaged product
Deep Sprouted Moong, 16 oz, is recalled after the product tested positive for Salmonella. The FDA classified the action as Class I. 5,616 packets are affected.
Product
Deep Sprouted Moong 16 oz
Category
Food
Distribution
5 states