Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
FDA DevicesPatient Information Center iX; Software Version Number: 4.5.0
Patient Information Center iX; Software Version Number: 4.5.0
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
FDA DevicesMerit Medical , Custom Manifold Kit REF: K09-13203A
Merit Medical , Custom Manifold Kit REF: K09-13203A
Inflation device handle may detach from the syringe during procedure.
FDA DevicesICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
FDA DevicesBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
FDA DevicesICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
FDA DevicesBrand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
FDA FoodGaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
Undeclared colors FD&C Yellow #5
NHTSAKia America, Inc. - Instrument Panel Display Failure/FMVSS 101, 138
Kia America, Inc. - Instrument Panel Display Failure/FMVSS 101, 138
An instrument panel display that fails to show critical safety information, such as the speedometer, tire pressure, or warning lights, increases the risk of a crash.
NHTSAHyundai Motor America - Instrument Panel Display Failure/FMVSS 101
Hyundai Motor America - Instrument Panel Display Failure/FMVSS 101
An instrument panel display that fails to show critical safety information, such as the speedometer or warning lights, increases the risk of a crash.
NHTSAKeystone RV Company - Murphy Bed May Fall Unexpectedly
Keystone RV Company - Murphy Bed May Fall Unexpectedly
A murphy bed that falls increases the risk of injury.
NHTSAGrand Design RV, LLC - U-Bolt May Loosen and Shift Axle
Grand Design RV, LLC - U-Bolt May Loosen and Shift Axle
An axle that moves out of position can cause a loss of vehicle control and increase the risk of a crash.
NHTSAForest River Bus, LLC - Body Panel Joint Incorrectly Attached/FMVSS 221
Forest River Bus, LLC - Body Panel Joint Incorrectly Attached/FMVSS 221
Separated body panels can reduce structural integrity, increasing the risk of injury in a crash.
NHTSABrinkley RV - Improperly Tightened 50-Amp Shore Power Inlet May Cause Fire
Brinkley RV - Improperly Tightened 50-Amp Shore Power Inlet May Cause Fire
The wires may loosen and overheat, increasing the risk of a fire.
NHTSAHyundai Motor America - Side Curtain Air Bag May Deploy Improperly/FMVSS 226
Hyundai Motor America - Side Curtain Air Bag May Deploy Improperly/FMVSS 226
Improper side curtain air bag deployment increases the risk of injury during a crash.
NHTSAForest River, Inc. - 7-Way Connector Missing Over-Current Protection
Forest River, Inc. - 7-Way Connector Missing Over-Current Protection
Without over-current protection, a short circuit can increase the risk of a fire.
NHTSAFWMOTO INC. - Rear Wheel Hub Missing DOT Marking/FMVSS 123
FWMOTO INC. - Rear Wheel Hub Missing DOT Marking/FMVSS 123
The wheel hub may be improperly assembled or installed without the proper markings to identify the part, increasing the risk of a crash or injury.
NHTSAFWMOTO INC. - Insufficient Braking Performance/FMVSS 122
FWMOTO INC. - Insufficient Braking Performance/FMVSS 122
Insufficient braking performance can extend the distance required to stop or cause a loss of vehicle control, increasing the risk of a crash or injury.
NHTSAGrand Design RV, LLC - Solar Panel May Detach From RV
Grand Design RV, LLC - Solar Panel May Detach From RV
A detached solar panel can become a road hazard for other vehicles, increasing the risk of a crash.
NHTSAToyota Motor Engineering & Manufacturing - Rearview Camera Image May Not Display/FMVSS 111
Toyota Motor Engineering & Manufacturing - Rearview Camera Image May Not Display/FMVSS 111
A rearview camera image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
NHTSAToyota Motor Engineering & Manufacturing - Incorrect Side Marker Lights/FMVSS 108
Toyota Motor Engineering & Manufacturing - Incorrect Side Marker Lights/FMVSS 108
Without the correct lights, it may be difficult for other road users to see the vehicle from the rear or side, increasing the risk of a crash.
NHTSAForest River Bus, LLC - Body Panel Joint Incorrectly Attached/FMVSS 221
Forest River Bus, LLC - Body Panel Joint Incorrectly Attached/FMVSS 221
Separated body panels can reduce structural integrity, increasing the risk of injury in a crash.
NHTSAPolestar Automotive USA, Inc. - Loose Rear Seat Backrest/FMVSS 207
Polestar Automotive USA, Inc. - Loose Rear Seat Backrest/FMVSS 207
A loose rear seat backrest may fall forward and allow cargo to enter the cabin during a crash, increasing the risk of injury.
CPSCTopkay Lighters Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Violates Mandatory Standard for Multipurpose Lighters; Sold on Amazon by Xiyude
Topkay Lighters Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Violates Mandatory Standard for Multipurpose Lighters; Sold on Amazon by Xiyude
The recalled lighters violate the mandatory standard for multipurpose lighters because they do not have the required child-resistant mechanisms, posing a risk of serious injury or death from fire and burn hazards.