HIGH
FDA FOOD
Loard's Pecan Praline Ice Cream - 32 oz
Undeclared Milk, Pecans.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
High Risk Recalls
3,609 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.
What to do if you own a recalled product:
- Stop using the product immediately
- Keep the product away from children
- Follow the remedy instructions provided
- Contact the manufacturer for a refund or replacement
HIGH
FDA FOOD
Loard's Egg Nog Ice Cream - 32 oz
Undeclared Milk, Eggs, Yellow #5.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
HIGH
FDA FOOD
Loard's Pumpkin Ice Cream - 32 oz
Undeclared Milk, Yellow #6.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
HIGH
FDA FOOD
Loard's Sea Salt Caramel Ice Cream - 32 oz
Undeclared Milk, Soy, Sulfites.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
HIGH
FDA FOOD
Loard's Cherry Vanilla Ice Cream - 32 oz
Undeclared Milk, Red #40.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
HIGH
FDA FOOD
Loard's Mango Ice Cream - 32 oz; 56 oz
Undeclared Milk, Yellow #5.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
HIGH
FDA FOOD
Loard's Horchata Ice Cream - 32 oz
Undeclared Milk, Soy.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
HIGH
FDA FOOD
Loard's Raspberry Sherbert - 32 oz
Undeclared Milk, Red #40.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk,
HIGH
FDA FOOD
Loard's Butterscotch Marble Ice Cream - 32 oz
Undeclared Milk.
Silver Moon LP dba Loard's Ice Cream
Undeclared Milk.
HIGH
FDA DEVICE
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397,...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k)...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DRUG
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
MONSELS SOLUTION
Labeling: Incorrect
HIGH
FDA DEVICE
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips North America
The potential
HIGH
FDA DEVICE
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product...
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Dexcom
A software
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