Hazard

Class I recalls

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

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.

226–250 of 457

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-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-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-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
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-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 (Drugs)·D-0611-2025·2025-09-10
External analgesic lotion recalled over Burkholderia cepacia contamination
DermaSarra External Analgesic containing camphor 0.5%, lot 40187.2, is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.
Product
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Category
Drug
Distribution
Distributed nationwide
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
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-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-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
0 states
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 (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
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 (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-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-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-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 (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-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-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 (Drugs)·D-0628-2025·2025-09-10
Sodium chloride injection containers recalled over presence of particulate matter
B. Braun 0.9% Sodium Chloride Injection USP in 1000 mL containers, lot V3K770, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 47,148 containers are affected.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM 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 (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-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