Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IICheck your Edan patient monitor for cybersecurity issues
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.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IICheck Edan iM3s monitor serial number
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.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IICheck Edan iM3 monitor for security update
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.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IICheck Edan M3 vital signs monitors for security update
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.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IICheck your Edan fetal monitor model
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.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IICheck your Edan fetal monitor model and serial number
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.
- 2026-01-28FDA-DeviceCommunity Products, LLCClass IICheck your Rifton E-Pacer gait trainer for fraying
Potential for fraying on the body support strap.
- 2026-01-28FDA-DeviceCommunity Products, LLCClass IICheck your Rifton TRAM lift device for strap damage
Potential for fraying on the body support strap.
- 2026-01-28FDA-DeviceCommunity Products, LLCClass IICheck your Rifton TRAM lift device
Potential for fraying on the body support strap.
- 2026-01-28FDA-DeviceSysmex America, Inc.Class IICheck your Sysmex TS-10/TS-10H Tube Sorter
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
- 2026-01-28FDA-DeviceBeckman Coulter Ireland, Inc.Class IIStop using Beckman Coulter LDL Cholesterol OSR6x96
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).
- 2026-01-28FDA-DeviceIntuitive Surgical, Inc.Class IICheck your Ion Vision Probe Bag lot number
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
- 2026-01-28FDA-DeviceMicroPort Orthopedics Inc.Class IIStop using MicroPort HIPTURN hip implant trial
Due to products not having FDA Premarket authorization to be distributed within the United States.
- 2026-01-28FDA-DeviceTyber MedicalClass IICheck Tyber Medical VOLT wrist plates
The supplier manufactured anatomical left plates with an incorrect thread orientation.
- 2026-01-28FDA-DeviceTyber MedicalClass IICheck Tyber Medical VOLT wrist plates
The supplier manufactured anatomical left plates with an incorrect thread orientation.
- 2026-01-28FDA-DeviceLEASEIR TECHNOLOGIES SLUClass IICheck your Leaseir MHR Xcell laser console label
The console label for affected devices is missing the "DANGER" symbol.
- 2026-01-28FDA-DeviceMerit Medical Systems, Inc.Class IIStop using Merit Medical angioplasty packs
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit Medical Systems, Inc.Class IIStop using Merit Medical Custom Procedure Kits
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit Medical Systems, Inc.Class IIStop using Merit Medical Custom Manifold Kit
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit Medical Systems, Inc.Class IIStop using Merit Medical inflation kits
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit Medical Systems, Inc.Class IIStop using Merit Medical vascular tray immediately
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit Medical Systems, Inc.Class IIStop using Merit Medical Allwell Inflation Device
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit Medical Systems, Inc.Class IIStop using recalled Merit Medical inflation device
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMazor Robotics LtdClass IICheck Mazor X robotic system software
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
- 2026-01-28FDA-DeviceBaxter Healthcare CorporationClass IIStop using recalled Baxter SIGMA Spectrum pump
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
- 2026-01-28FDA-DeviceICU Medical, Inc.Class IIContact ICU Medical about Plum Solo IV Pump
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- 2026-01-28FDA-DeviceICU Medical, Inc.Class IICheck ICU Medical Plum Duo IV Pump software
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- 2026-01-28FDA-DeviceICU Medical, Inc.Class IICheck your ICU Medical Plum Duo pump software
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- 2026-01-28FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIContact Philips about your Azurion X-ray system
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
- 2026-01-28FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IICheck your GE Omni Legend PET scanner
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
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