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Consumer Product Recalls

127,244 recalls from the U.S. Consumer Product Safety Commission, newest first.

January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Mon
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Mon
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Descript
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS i
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX ser
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monit
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Descriptio
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three w
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Moni
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsid
Hazard: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
January 28, 2026Medical DevicesFDA
Community Products, LLC recalls Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjus
Hazard: Potential for fraying on the body support strap.
January 28, 2026Medical DevicesFDA
Community Products, LLC recalls Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clien
Hazard: Potential for fraying on the body support strap.
January 28, 2026Medical DevicesFDA
Community Products, LLC recalls Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a s
Hazard: Potential for fraying on the body support strap.
January 28, 2026Medical DevicesFDA
Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s
Hazard: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
January 28, 2026Medical DevicesFDA
Beckman Coulter Ireland, Inc. recalls The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol f
Hazard: Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
January 28, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version:
Hazard: Due to probe bags that may have a compromised or incomplete sterile pouch seal.
January 28, 2026Medical DevicesFDA
MicroPort Orthopedics Inc. recalls Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Vers
Hazard: Due to products not having FDA Premarket authorization to be distributed within the United States.
January 28, 2026Medical DevicesFDA
Tyber Medical recalls Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Mo
Hazard: The supplier manufactured anatomical left plates with an incorrect thread orientation.
January 28, 2026Medical DevicesFDA
Tyber Medical recalls Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Mo
Hazard: The supplier manufactured anatomical left plates with an incorrect thread orientation.
January 28, 2026Medical DevicesFDA
LEASEIR TECHNOLOGIES SLU recalls Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Produc
Hazard: The console label for affected devices is missing the "DANGER" symbol.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Allwell Angioplasty Pack REF: IS-30-B1/B
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Manifold Kit REF: K09-13203A
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Hazard: Inflation device handle may detach from the syringe during procedure.