États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
potential Clostridium botulinum contamination
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
potential Clostridium botulinum contamination
FDA FoodSwiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Undeclared Milk Allergen
FDA DevicesNAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
FDA FoodOptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875
potential Clostridium botulinum contamination
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Cherry- UPC# 5061033691264
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Cherry- UPC# 5061033691264
potential Clostridium botulinum contamination
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
FDA DevicesVivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
FDA FoodBarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 0 07196 60000 7
BarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 0 07196 60000 7
Undeclared Quinine
FDA DevicesProduct Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271
potential Clostridium botulinum contamination
FDA FoodBarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00190 5
BarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00190 5
Undeclared Quinine
FDA FoodRepackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Undeclared allergens (milk, soy, and peanut)
FDA DevicesVolk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
FDA FoodLost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.
FDA DevicesLH One Step Ovulation Test Device (Urine)
LH One Step Ovulation Test Device (Urine)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Strawberry- UPC# 5065006235271
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Strawberry- UPC# 5065006235271
potential Clostridium botulinum contamination
FDA FoodGLUTEN FREE 14" SEASONED VEGAN PIZZA CRUST; INGREDIENTS: WATER, RICE FLOUR, POTATO STARCH, RICE STARCH, TAPIOCA STARCH, CANE SUGAR, MODIFIED RICE STARCH, POTATO FLOUR, PEA FIBER, CONTAINS LESS THAN 2% OF THE FOLLOWING: CANOLA OIL, YEAST, SALT, CELLULOSE GEL, EXTRA VIRGIN OLIVE OIL, GARLIC POWDER, SPICES, XANTHAN GUM, CELLULOSE GUM, CULTURED BROW RICE, BROWN RICE FLOUR, CITRIC ACID, LACTIC ACID; MAY CONTAIN MILK AND EGGS; MANUFACTURED BY VENCE BAKERY; Net Case Wt: 14 LB 6 OZ (6.52 KG); Unit Net Wt: 11.5 OZ (326 G); COUNT: 20; KEEP FROZEN; GTIN code on shipper case (01) 0 0859955 00412 6
GLUTEN FREE 14" SEASONED VEGAN PIZZA CRUST; INGREDIENTS: WATER, RICE FLOUR, POTATO STARCH, RICE STARCH, TAPIOCA STARCH, CANE SUGAR, MODIFIED RICE STARCH, POTATO FLOUR, PEA FIBER, CONTAINS LESS THAN 2% OF THE FOLLOWING: CANOLA OIL, YEAST, SALT, CELLULOSE GEL, EXTRA VIRGIN OLIVE OIL, GARLIC POWDER, SPICES, XANTHAN GUM, CELLULOSE GUM, CULTURED BROW RICE, BROWN RICE FLOUR, CITRIC ACID, LACTIC ACID; MAY CONTAIN MILK AND EGGS; MANUFACTURED BY VENCE BAKERY; Net Case Wt: 14 LB 6 OZ (6.52 KG); Unit Net Wt: 11.5 OZ (326 G); COUNT: 20; KEEP FROZEN; GTIN code on shipper case (01) 0 0859955 00412 6
Product contains undeclared milk and egg
NHTSAVolvo Trucks North America - Rollaway Risk from Inadequate Parking Brake Force
Volvo Trucks North America - Rollaway Risk from Inadequate Parking Brake Force
Inadequate parking brake force can result in a rollaway, increasing the risk of a crash.
NHTSAVee Tyre and Rubber Co., Ltd. - Tire May Separate and Fail/FMVSS 139
Vee Tyre and Rubber Co., Ltd. - Tire May Separate and Fail/FMVSS 139
Tire separation can cause tire failure and a sudden loss of tire pressure, increasing the risk of a crash.
NHTSANova Bus (US) Inc. - Mounting Rails May Crack and Cause Seat to Fall
Nova Bus (US) Inc. - Mounting Rails May Crack and Cause Seat to Fall
A seat that falls unexpectedly increases the risk of injury to passengers in or near to the seat.
NHTSAPT. Elangperdana Tyre Industry - Tire Sidewall May Separate/FMVSS 139
PT. Elangperdana Tyre Industry - Tire Sidewall May Separate/FMVSS 139
Sidewall separation can cause tire failure, increasing the risk of a crash.
NHTSAHarley-Davidson Motor Company - Upper Triple Clamp May Fracture
Harley-Davidson Motor Company - Upper Triple Clamp May Fracture
An upper triple clamp that fractures can lead to a loss of control, increasing the risk of a crash.