Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Aju Pharm Fixone Hybrid Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-02-04FDA-DeviceCerapedics, Inc.Class IICheck Cerapedics PearMatrix P-15 expiration dates
Incorrect expiration date
- 2026-02-04FDA-DeviceElekta, Inc.Class IICheck your Elekta radiation therapy system
Due to a manufacturing issue and electrical grounding of systems.
- 2026-02-04FDA-DeviceSunMed Holdings, LLCClass IStop using affected Broselow Tape units
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
- 2026-02-04FDA-DeviceSunMed Holdings, LLCClass IStop using Broselow ALS Organizer model 7730ALS
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
- 2026-02-04FDA-DeviceSunMed Holdings, LLCClass IStop using affected Broselow emergency tape
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
- 2026-02-04FDA-DeviceSunMed Holdings, LLCClass IStop using SunMed Broselow emergency tape
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
- 2026-01-28FDA-DeviceGVS TM, IncClass IIStop using GVS SQ40S blood transfusion filters
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
- 2026-01-28FDA-DevicePhilips North AmericaClass IICheck Philips Patient Information Center iX settings
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
- 2026-01-28FDA-DeviceEdan DiagnosticsClass IICheck your Edan iT20 telemetry transmitter
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 iM8 patient monitor security
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 M3A vital signs 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 IICheck your Edan M3B 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 your Edan fetal monitoring system
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 MFM-CMS central monitoring system
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 patient 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 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 IICheck 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 IICheck 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 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).
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief