Quick Facts at a Glance
- Recall Date
- December 10, 2025
- Hazard Level
- HIGH
- Brand
- Mazor Robotics
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Mazor Robotics
- Product type
- Robotic Guidance System
- Model numbers
- Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517 +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 10, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mazor Robotics Ltd or your healthcare provider for instructions. Notification method: Letter
About This Product
The Mazor X robotic guidance system assists surgeons in performing spinal surgeries with enhanced precision. Healthcare providers use this device to improve outcomes and reduce risks during complex procedures.
Why This Is Dangerous
The software errors in the Mazor X guidance system can lead to incorrect positioning of surgical instruments, potentially compromising surgical accuracy and patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must take immediate action to avoid serious surgical risks. The recall may disrupt surgical schedules and affect patient treatment plans.
Practical Guidance
How to identify if yours is affected
- Check the software version of your Mazor X robotic guidance system.
- Refer to the list of affected software versions: 5.0.1, 5.1.2, 5.1.3.
- Contact your healthcare provider for assistance in checking if your system is affected.
Where to find product info
The software version can usually be found in the system's settings or user manual.
What timeline to expect
Expect a response regarding your recall inquiry within 4-6 weeks.
If the manufacturer is unresponsive
- Document your communications with the company.
- Contact the FDA to report unresponsiveness.
- Consider consulting with a legal expert if necessary.
How to prevent similar issues
- Ensure devices have the latest software updates before use.
- Ask about device recalls during purchasing or service consultations.
- Be aware of recent recalls in the healthcare field.
Documentation advice
Keep records of your purchase, any correspondence with the manufacturer, and notes on your system's software version.
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Product Details
The recall affects Mazor X robotic guidance systems with software versions 5.0.1, 5.1.2, and 5.1.3. These systems were distributed worldwide, including in the United States, Canada, and several European countries. The systems are classified as Class II medical devices.
Key Facts
- Software errors can affect surgical procedures
- Worldwide distribution including the US and several countries
- Immediate stop-use action required
- Contact manufacturer for further guidance
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