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

2251–2275 of 27346

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-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-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-2431-2025·2025-09-10
WATCHMAN TruSeal access systems recalled over air embolism during transseptal access
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; 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-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-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
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-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-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-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-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-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-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-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
HighFDA (Devices)·Z-2527-2025·2025-09-10
NRFit yellow cassette reservoirs recalled over weakened medication bag welds
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoirs, 100 mL, product code 21-7600-24, may have weakened medication bag welds that could allow leakage. 15,546 units are affected.
Product
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2507-2025·2025-09-10
MediHoney HCS sheet dressings recalled over packaging failures breaching sterility
MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination w
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2496-2025·2025-09-10
InPen app recalled over software errors affecting insulin dose reminders
Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.
Product
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2502-2025·2025-09-10
Azurion imaging systems recalled because single phase UPS may fail on power loss
Philips Azurion systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,861 units are affected.
Product
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2510-2025·2025-09-10
MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures
MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2503-2025·2025-09-10
Interventional imaging systems recalled because single phase UPS may fail on power loss
Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.
Product
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2526-2025·2025-09-10
CADD 100 mL flow stop reservoirs recalled over weakened bag welds
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7302-24, may have weakened medication bag welds that could allow leakage. 987,911 units are affected.
Product
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2523-2025·2025-09-10
Medication cassette reservoirs recalled over weakened bag welds causing leakage
Smiths Medical CADD Medication Cassette Reservoirs may have weakened medication bag welds along the bag perimeter, which could result in medication leakage. 265,500 units are affected.
Product
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2522-2025·2025-09-10
CADD 50 mL cassette reservoirs recalled over weakened bag welds
Smiths Medical CADD Medication Cassette Reservoirs, 50 mL, product code 21-7001-24, may have weakened medication bag welds that could allow leakage. 29,811 units are affected.
Product
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Category
Medical Device
Distribution
0 states

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2251–2275 of 27346