États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA FoodMini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
Mini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
Undeclared colors FD&C Yellow #5
FDA DevicesBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) 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 abnormity so that doctors and nurses can deal with them in time. Component: No
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) 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 abnormity so that doctors and nurses can deal with them in time. 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 DevicesMerit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Inflation device handle may detach from the syringe during procedure.
FDA DevicesGE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
FDA DrugsDiclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Failed PH Specifications
FDA FoodAustralian Greenlip Abalone, Frozen, 9 pieces, Net Wt. 23.5 OZ UPC: 9335533013342
Australian Greenlip Abalone, Frozen, 9 pieces, Net Wt. 23.5 OZ UPC: 9335533013342
Potential Listeria Monocytogenes contamination
FDA DrugsFurosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.
Presence of Foreign Substance
FDA DevicesMEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
CPSCMikario Trading Convertible Baby Gyms Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standard for Infant Support Cushions; Sold on TikTok Shop
Mikario Trading Convertible Baby Gyms Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standard for Infant Support Cushions; Sold on TikTok Shop
The recalled baby gyms violate the mandatory safety standard for infant support cushions because the floor mats can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.