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.
- 2026-02-04FDA-DeviceCanon Medical System, USA, INC.Class IIContact Canon Medical about your Alphenix X-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- 2026-02-04FDA-DeviceCanon Medical System, USA, INC.Class IICheck your Canon Medical X-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- 2026-02-04FDA-DeviceSiemens Medical Solutions USA, IncClass IIContact Siemens about your LUMINOS Q.namix T system
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
- 2026-02-04FDA-DeviceSiemens Medical Solutions USA, IncClass IIContact Siemens about your LUMINOS Q.namix R X-ray system
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Aju Pharm AlternatiV+ anchors
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Aju Pharm AlternatiV+ Max anchors
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Aju Pharm suture anchors
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Genesis Knotless Anchor devices
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Genesis Dual Thread Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Genesis Screw-In Anchor devices
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-02-04FDA-DeviceAju Pharm Co., Ltd.Class IIStop using Aju Pharm Fixone Biocomposite Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 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.
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