DC recalls
3293 federal recalls on file affecting DC - 218 DC-specific plus 3075 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IINationwideCheck your Edan patient 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 IINationwideCheck your Edan iM20 patient monitor
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 IINationwideCheck your Edan patient monitor for updates
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 IINationwideCheck 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 IINationwideCheck 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 IINationwideCheck 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 IINationwideCheck 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 IINationwideCheck 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 IINationwideCheck 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 ProductsClass IINationwideCheck your Rifton E-Pacer gait trainer for fraying
Potential for fraying on the body support strap.
- 2026-01-28FDA-DeviceCommunity ProductsClass IINationwideCheck your Rifton TRAM lift device for strap damage
Potential for fraying on the body support strap.
- 2026-01-28FDA-DeviceCommunity ProductsClass IINationwideCheck your Rifton TRAM lift device
Potential for fraying on the body support strap.
- 2026-01-28FDA-DeviceSysmexClass IINationwideCheck 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 CoulterClass IINationwideStop 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 SurgicalClass IINationwideCheck your Ion Vision Probe Bag lot number
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
- 2026-01-28FDA-DeviceTyber MedicalClass IINationwideCheck Tyber Medical VOLT wrist plates
The supplier manufactured anatomical left plates with an incorrect thread orientation.
- 2026-01-28FDA-DeviceTyber MedicalClass IINationwideCheck Tyber Medical VOLT wrist plates
The supplier manufactured anatomical left plates with an incorrect thread orientation.
- 2026-01-28FDA-DeviceLeaseir TechnologiesClass IINationwideCheck your Leaseir MHR Xcell laser console label
The console label for affected devices is missing the "DANGER" symbol.
- 2026-01-28FDA-DeviceMerit MedicalClass IINationwideStop using Merit Medical angioplasty packs
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit MedicalClass IINationwideStop using Merit Medical Custom Procedure Kits
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit MedicalClass IINationwideStop using Merit Medical Custom Manifold Kit
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit MedicalClass IINationwideStop using Merit Medical inflation kits
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit MedicalClass IINationwideStop using Merit Medical vascular tray immediately
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit MedicalClass IINationwideStop using Merit Medical Allwell Inflation Device
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMerit MedicalClass IINationwideStop using recalled Merit Medical inflation device
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceMazor RoboticsClass IINationwideCheck Mazor X robotic system software
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
- 2026-01-28FDA-DeviceBaxterClass IINationwideStop 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 MedicalClass IINationwideContact 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 MedicalClass IINationwideCheck 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 MedicalClass IINationwideCheck 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.
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