Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

3176–3200 of 39987

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-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-2435-2025·2025-09-10
FXD Curve double access systems recalled over transseptal air embolism risk
Boston Scientific is recalling WATCHMAN FXD Curve Access System Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; 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-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-2432-2025·2025-09-10
TruSeal DBL access systems recalled over air embolism risk without ventilation
Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; 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-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-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-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-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-2454-2025·2025-09-10
Wheelchair joysticks recalled over unintended movement on power-up
Micro 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
Micro Joystick R-net. Electrical wheelchair component.
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-2334-2025·2025-09-10
Novum IQ syringe pumps recalled over software anomalies affecting the run screen
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40700BAX, over software anomalies that may cause a blank Run screen or a false motor movement system error. 22,703 units are affected.
Product
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Category
Medical Device
Distribution
1 state
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-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-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-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 Monitor
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2480-2025·2025-09-10
Left heart vent catheters 13FR recalled because they may not retain shape
DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
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-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

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3176–3200 of 39987