Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DevicesBrand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesHeraeus, PALAMIX duo. Material Number: 66057897.
Heraeus, PALAMIX duo. Material Number: 66057897.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA FoodNegita Cracker- Shrimp 2.8oz
Negita Cracker- Shrimp 2.8oz
Contains undeclared FD&C Yellow 6
FDA DrugsiVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
FDA FoodTop Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC 8 75343 00001 3. Keep Refrigerated. Made For Einstein Noah Restaurant Group Inc., Lakewood, CO 80228.
Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC 8 75343 00001 3. Keep Refrigerated. Made For Einstein Noah Restaurant Group Inc., Lakewood, CO 80228.
Undeclared allergen (almond).
FDA Food52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1
52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
FDA FoodMy Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
Foreign object found inside retail container.
FDA DrugsSimilasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
FDA DevicesDimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
FDA DevicesHeraeus, PALAMIX uno. Material Number: 66057893.
Heraeus, PALAMIX uno. Material Number: 66057893.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
NHTSAShyft Group - Incorrect Cargo Carrying Capacity on Label
Shyft Group - Incorrect Cargo Carrying Capacity on Label
Incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
NHTSAWinnebago Industries, Inc. - Incorrectly Routed LP Hose May Cause Fire
Winnebago Industries, Inc. - Incorrectly Routed LP Hose May Cause Fire
Heat exposure may damage the hose. A damaged hose may leak fuel, increasing the risk of a fire.
NHTSATesla, Inc. - Rearview Camera Image May Not Display/FMVSS 111
Tesla, Inc. - Rearview Camera Image May Not Display/FMVSS 111
A delayed rearview image reduces the driver's view behind the vehicle, increasing the risk of a crash.
NHTSAGulf States Toyota, Inc. - Incorrect Load Carrying Capacity on Label/FMVSS 110
Gulf States Toyota, Inc. - Incorrect Load Carrying Capacity on Label/FMVSS 110
An incorrect load carrying capacity label may lead to improper loading of the vehicle, increasing the risk of a crash.
USDA FSISFSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared Allergens
FSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared Allergens
Mislabeling, Unreported Allergens
NHTSABraun Corporation - Rear Bench May Be Missing Seat Legs
Braun Corporation - Rear Bench May Be Missing Seat Legs
An incomplete seat may not properly restrain an occupant, increasing risk of injury during a crash.
NHTSAWaymo LLC - ADS Software May Allow Vehicle to Drive onto a Flooded Roadway
Waymo LLC - ADS Software May Allow Vehicle to Drive onto a Flooded Roadway
Entering a flooded roadway can cause a loss of vehicle control, increasing the risk of a crash or injury.
NHTSANew Flyer of America, Inc. - Speedometer May Fail to Illuminate/FVMSS 101
New Flyer of America, Inc. - Speedometer May Fail to Illuminate/FVMSS 101
An unlit speedometer cannot show the vehicle's speed, increasing the risk of a crash.
NHTSAMercedes-Benz USA, LLC - Blank Instrument Panel Display
Mercedes-Benz USA, LLC - Blank Instrument Panel Display
An instrument panel display that fails to show critical safety information, such as the speedometer and warning lights, increases the risk of a crash.
NHTSAMercedes-Benz USA, LLC - Front Passenger Seat Belt May Not Fasten
Mercedes-Benz USA, LLC - Front Passenger Seat Belt May Not Fasten
A passenger who is unable to fasten their seat belt is not properly restrained, increasing their risk of injury in a crash.
USDA FSISFSIS Issues Public Health Alert for Various Meat and Poultry Products Containing FDA-Regulated Dairy Products That Have Been Recalled Due to Possible Salmonella Contamination
FSIS Issues Public Health Alert for Various Meat and Poultry Products Containing FDA-Regulated Dairy Products That Have Been Recalled Due to Possible Salmonella Contamination
Product Contamination
CPSCCBC Group Recalls Stephan Baby Boo Bunnie and Friends Children's Toys Due to Risk of Serious Injury from Choking and Laceration Hazards
CBC Group Recalls Stephan Baby Boo Bunnie and Friends Children's Toys Due to Risk of Serious Injury from Choking and Laceration Hazards
The toys' plastic cube can break into small parts or sharp edges, posing a risk of serious injury from choking and laceration hazards.