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.

526–550 of 7436

CriticalFDA (Devices)·Z-2539-2025·2025-09-24
SmartDrive MX2-3DCK dials recalled over faulty connection to wheelchair motor
SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCK, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 15,834 units are affected.
Product
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Category
Medical Device
Distribution
52 states
CriticalFDA (Food)·H-0615-2025·2025-09-24
Chili crunch mezze packs recalled over undeclared wheat in ready-to-eat sandwiches
Chili Crunch Market Mezze, 14.5 oz, from Fresh and Ready Foods is recalled for undeclared wheat. The FDA classified the action as Class I. 233 units are affected.
Product
Chili Crunch Market Mezze; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
Category
Food
Distribution
1 state
CriticalFDA (Food)·H-0572-2025·2025-09-17
Caramel apple pecan topped brie recalled over possible Listeria contamination
Wegmans Caramel Apple Pecan Topped Brie Cheese, small 13 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
Product
Wegmans Caramel Apple Pecan Topped Brie Cheese -Small - 13 OZ - Clear plastic container with lid UPC: 2-77645-XXXXX-3 (X - varies by weighted price)
Category
Food
Distribution
10 states
CriticalFDA (Food)·H-0569-2025·2025-09-17
Camembert soft ripened cheese recalled over possible Listeria monocytogenes contamination
Wegmans Medium Camembert Soft Ripened Cheese, 8.8 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
Product
Wegmans Medium Camembert Soft Ripened Cheese - 8.8oz - Round wooded container; UPC: 2-77467-00000-7 , 0-77890-53515-8
Category
Food
Distribution
10 states
CriticalFDA (Devices)·Z-2484-2025·2025-09-17
Aspiration biopsy needles recalled over undetected deformed atraumatic tips
ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.
Product
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0570-2025·2025-09-17
Assorted cheese flight recalled over possible Listeria monocytogenes contamination
Wegmans Assorted Cheese Flight, sold by the pound, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
Product
Wegmans Assorted Cheese Flight - Varies (sold by the lb) - Black Plastic container with clear lid UPC: 2-77100-XXXXX-5 (X - varies by weighted price)
Category
Food
Distribution
10 states
CriticalFDA (Food)·H-0571-2025·2025-09-17
Grilling camembert with tapenade recalled over possible Listeria monocytogenes contamination
Wegmans Grilling Camembert with Tapenade & Roasted Tomatoes, 10 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
Product
Wegmans Grilling Camembert with Tapenade & Roasted Tomatoes - 10 OZ - Overwrapped black and gold metal tray UPC: 2-77297-XXXXX-0 (X - varies by weighted price)
Category
Food
Distribution
10 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 (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-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 (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-2482-2025·2025-09-10
Left heart vent catheters recalled because they may not retain shape
DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
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-2457-2025·2025-09-10
IDM-MULTI-R wheelchair controls recalled over unintended movement at power-up
IDM-MULTI-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-MULTI-R. 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-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-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-2333-2025·2025-09-10
Syringe pumps recalled over false motor movement system error messages
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.
Product
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Category
Medical Device
Distribution
1 state
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 (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-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 (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-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 (Food)·H-0616-2025·2025-09-10
Honey balsamic salad kits recalled over undeclared sesame and soy allergens
Taylor Farms Honey Balsamic Salad Kits, 8.3 oz, are recalled for undeclared sesame and soy. The FDA classified the action as Class I. 8,284 cases are affected.
Product
Salad Kit labeled as follows: Taylor FARMS Honey Balsamic SALAD KIT, NET WT. 8.3 OZ (235g), INGREDIENTS: HONEY BALSAMIC VINAIGRETTE (soybean oil ...) SPINACH, CARROT, SEA SALT CROISSANT CROUTON (wheat flour ...) CRUMBLED FETA CHEESE (feta cheese [pasteurized milk ...] ...) MIZUNA
Category
Food
Distribution
18 states