Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,116 results
Medical Device
FDA Devices
FDA DevicesVortex Surgical I2 Injection Kit, VS0500
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Surgical I2 Injection Kit, VS0500
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: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 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 ¿-Amyloid 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 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics, Inc.
FDA DevicesClass II
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 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 ¿-Amyloid 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 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 DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 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 Model/Catalog Number: KD-V411M-3030 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 DevicesNAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
FDA DevicesClass II
NAEOTOM Alpha.Pro 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.
Feb 11, 2026Siemens Medical Solutions USA, Inc
Medical DeviceFDA Devices
FDA DevicesBrand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Feb 11, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Pineapple- UPC# 5065006235288
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Pineapple- UPC# 5065006235288
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Medical DeviceFDA Devices
FDA DevicesPRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA DevicesClass II
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Feb 11, 2026VANTIVE US HEALTHCARE LLC
Medical DeviceFDA Devices
FDA DevicesBrand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesSOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
FDA DevicesClass II
SOMATOM X.ceed 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.
Feb 11, 2026Siemens Medical Solutions USA, Inc
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; 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 Model/Catalog Number: KD-V411M-0730; 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
Medical DeviceFDA Devices
FDA DevicesPRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA DevicesClass II
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Feb 11, 2026VANTIVE US HEALTHCARE LLC
Food & BeverageFDA Food
FDA FoodJUICE from the Raw, DETOX GREENS
Everpress Juice
FDA FoodClass I
JUICE from the Raw, DETOX GREENS
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. Passion Fruit- UPC# 5061033691882
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Food & BeverageFDA Food
FDA FoodRepackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro, 3. Jaxport, Jacksonville Port Authority, 4. Climax Molybdenum, A Freeport-McMoRan Company, 5. University of Maryland, School of Public Policy, 6. Liberty University Environmental Health & Safety, 7. Subaru, 8. Trinity Cyb3r, 9. Candy Treats, 10. JSE, Jordan & Skala Engineers, 11. Dropbox DocSend, 12. PP, Prosperity Promotions, 13. Northwest Indian College Foundation, 14. FES Branding Solutions, 15. Berkshire Hathaway Guard Insurance Companies, 16. merry maids Annual 26 Conference, 17. BW, Best Western, 18. Morgan Stanley, 19. tufin, 20. Compliments of Pioneer, 21. A.D. Morgan, Construction Manager, Design Builder, General Contractor, 22. Adobe, 23. xfinity, 24. Fundermax Interiors, 25. White Cup, 26. Acadia Commercial, 27. Aviagen, 28. ORG Expo, 29. Make Your Mark For nutrition facts, information, and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Beacon Promotions Inc
FDA FoodClass II
Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro, 3. Jaxport, Jacksonville Port Authority, 4. Climax Molybdenum, A Freeport-McMoRan Company, 5. University of Maryland, School of Public Policy, 6. Liberty University Environmental Health & Safety, 7. Subaru, 8. Trinity Cyb3r, 9. Candy Treats, 10. JSE, Jordan & Skala Engineers, 11. Dropbox DocSend, 12. PP, Prosperity Promotions, 13. Northwest Indian College Foundation, 14. FES Branding Solutions, 15. Berkshire Hathaway Guard Insurance Companies, 16. merry maids Annual 26 Conference, 17. BW, Best Western, 18. Morgan Stanley, 19. tufin, 20. Compliments of Pioneer, 21. A.D. Morgan, Construction Manager, Design Builder, General Contractor, 22. Adobe, 23. xfinity, 24. Fundermax Interiors, 25. White Cup, 26. Acadia Commercial, 27. Aviagen, 28. ORG Expo, 29. Make Your Mark For nutrition facts, information, and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Undeclared allergens (milk, soy, and peanut)
Feb 11, 2026Beacon Promotions Inc
PharmaceuticalFDA Drugs
FDA DrugsRheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC
FDA DrugsClass I
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
CGMP Deviations: product found to contain lead.
Feb 11, 2026HANDELNINE GLOBAL LLC
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; 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-VC433Q-0730; 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
Medical DeviceFDA Devices
FDA DevicesVortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
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 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
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Elderberry- UPC# 5065006235189
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Elderberry- UPC# 5065006235189
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. 5 Blend in 1- UPC# 5061033690052
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. 5 Blend in 1- UPC# 5061033690052
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Medical DeviceFDA Devices
FDA DevicesProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-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-431Q-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
Food & BeverageFDA Food
FDA FoodImu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packaging: Plastic jar with Sealed lid. Net Weight: 7 ounces. UPC:7 38654 00033 5 Firm name on label: Imu-Tek, 3541 East Vine Drive, Fort Collins, CO 80524
Imu-Tek Animal Health, Incorporated
FDA FoodClass II
Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packaging: Plastic jar with Sealed lid. Net Weight: 7 ounces. UPC:7 38654 00033 5 Firm name on label: Imu-Tek, 3541 East Vine Drive, Fort Collins, CO 80524
Undeclared milk allergen
Feb 11, 2026Imu-Tek Animal Health, Incorporated
Medical DeviceFDA Devices
FDA DevicesHOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Boston Scientific Corporation
FDA DevicesClass I
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Feb 11, 2026Boston Scientific Corporation
Medical DeviceFDA Devices
FDA DevicesPRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA DevicesClass II
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Feb 11, 2026VANTIVE US HEALTHCARE LLC