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Medical Device
FDA Devices
FDA DevicesProduct Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics, Inc.
FDA DevicesClass II
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 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).
Feb 11, 2026Fujirebio Diagnostics, Inc.
Medical DeviceFDA Devices
FDA DevicesBrand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
ETAC A/S
FDA DevicesClass II
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
Feb 11, 2026ETAC A/S
Medical DeviceFDA Devices
FDA DevicesProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 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.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 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.
Feb 11, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA Foodspicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 3.4oz (96g) Ingredients: Salt, *Garlic *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007643
Organic Spices, Inc
FDA FoodClass II
spicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 3.4oz (96g) Ingredients: Salt, *Garlic *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007643
Product contains salt and is mislabeled
Feb 11, 2026Organic Spices, Inc
Food & BeverageFDA Food
FDA FoodSofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Tai Phat Wholesalers, LLC
FDA FoodClass I
Sofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Undeclared sulfites
Feb 11, 2026Tai Phat Wholesalers, LLC
Food & BeverageFDA Food
FDA FoodJUICE from the Raw, cashew milk
Everpress Juice
FDA FoodClass I
JUICE from the Raw, cashew milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
Feb 11, 2026Everpress Juice
Food & BeverageFDA Food
FDA FoodJUICE from the Raw, upbeat
Everpress Juice
FDA FoodClass I
JUICE from the Raw, upbeat
Under-processed product may contain pathogenic bacteria that could harm to humans.
Feb 11, 2026Everpress Juice
Food & BeverageFDA Food
FDA Foodspicely ORGANIC sumac NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2oz (56g) Ingredients: Organic Sumac, Salt www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007339
Organic Spices, Inc
FDA FoodClass II
spicely ORGANIC sumac NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2oz (56g) Ingredients: Organic Sumac, Salt www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007339
Product contains salt and is mislabeled
Feb 11, 2026Organic Spices, Inc
Food & Beverage
RappelConso
RappelConsoconserverie la granvillaise - rillettes conserverie la granvillaise
conserverie la granvillaise
RappelConsoimposé par arrê...
conserverie la granvillaise - rillettes conserverie la granvillaise
défaut de fabrication
Feb 11, 2026conserverie la granvillaise
Medical DeviceFDA Devices
FDA DevicesProduct Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse pTau 217 Plasma Controls: Liquid (Frozen), 2 ¿2 Concentrations L1 Level 1 (2¿ 1.5 mL) L2 Level 2 (2¿ 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics, Inc.
FDA DevicesClass II
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse pTau 217 Plasma Controls: Liquid (Frozen), 2 ¿2 Concentrations L1 Level 1 (2¿ 1.5 mL) L2 Level 2 (2¿ 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 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).
Feb 11, 2026Fujirebio Diagnostics, Inc.
Medical DeviceFDA Devices
FDA DevicesBrand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
ETAC A/S
FDA DevicesClass II
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
Feb 11, 2026ETAC A/S
Food & BeverageRappelConso
RappelConsola ferme aux biches - conserves de cerf
la ferme aux biches
RappelConsovolontaire (san...
la ferme aux biches - conserves de cerf
perte de maitrise du process de sterilisation
Feb 11, 2026la ferme aux biches
Food & BeverageFDA Food
FDA FoodJUICE from the Raw, cashew coffee milk
Everpress Juice
FDA FoodClass I
JUICE from the Raw, cashew coffee milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
Feb 11, 2026Everpress Juice
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Soursop- UPC# 5061033691875
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Soursop- UPC# 5061033691875
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Food & BeverageFDA Food
FDA FoodWilly Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) & Salt. Coconut, Sugar, Water Propylene Glycol (Sustains Freshness), Salt, Sodium Metabisulfite (Preserves Whiteness). Macadamia nuts & Carolina Reaper Powder; Contains Milk and Soy. Tree Nuts. May contain traces of peanuts; UPC: 0 987261 5
Willy Pete's Chocolate Company LLC
FDA FoodClass III
Willy Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) & Salt. Coconut, Sugar, Water Propylene Glycol (Sustains Freshness), Salt, Sodium Metabisulfite (Preserves Whiteness). Macadamia nuts & Carolina Reaper Powder; Contains Milk and Soy. Tree Nuts. May contain traces of peanuts; UPC: 0 987261 5
Almonds are not declared in the ingredient statement. Almond is included in description of product on front label.
Feb 11, 2026Willy Pete's Chocolate Company LLC
Medical DeviceFDA Devices
FDA DevicesVortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
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.
Feb 11, 2026Vortex Surgical Inc.
Medical DeviceFDA Devices
FDA DevicesProduct Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Wilson-Cook Medical Inc.
FDA DevicesClass II
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
Feb 11, 2026Wilson-Cook Medical Inc.
Vehicle RecallNHTSA
NHTSATriumph Motorcycles America, Ltd. - Alternator Wiring May Short and Overheat
Triumph Motorcycles America, Ltd.
NHTSAELECTRICAL SYSTEM
Triumph Motorcycles America, Ltd. - Alternator Wiring May Short and Overheat
Overheated wiring increases the risk of a crash or fire.
Feb 11, 2026Triumph Motorcycles America, Ltd.
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Medical DeviceFDA Devices
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
Fujirebio Diagnostics, Inc.
FDA DevicesClass II
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).
Feb 11, 2026Fujirebio Diagnostics, Inc.
Medical DeviceFDA Devices
FDA DevicesVortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
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.
Feb 11, 2026Vortex Surgical Inc.
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Strawberry- UPC# 5065006235271
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Strawberry- UPC# 5065006235271
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Medical DeviceFDA Devices
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.
Olympus Corporation of the Americas
FDA DevicesClass II
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.
Feb 11, 2026Olympus Corporation of the Americas