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Consumer Product Recalls
127,244 recalls from the U.S. Consumer Product Safety Commission, newest first.
February 11, 2026Medical DevicesFDA
Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr
Hazard: 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).
February 11, 2026Medical DevicesFDA
Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not
Hazard: 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).
February 11, 2026Medical DevicesFDA
Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Appli
Hazard: 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).
February 11, 2026Medical DevicesFDA
Maquet Cardiopulmonary Gmbh recalls Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Hazard: Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
February 11, 2026Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Hazard: It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
February 11, 2026Medical DevicesFDA
Wilson-Cook Medical Inc. recalls Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Hazard: Nasal feeding tube packaged without the nasal transfer tube component.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instr
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instr
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instr
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software V
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.