CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report
Mazor X robotic guidance system recalled by Mazor Robotics
Mazor Robotics is recalling Mazor X robotic guidance system, distributed nationwide in the US. The recall was initiated on 10 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1122-2026
- FDA event ID
- 98199
- Recalling firm
- Mazor Robotics, Caesarea
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Dec 2025
- FDA classified
- 16 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Dec 2025 | Recall initiated by company | |
| 16 Jan 2026 | Classified by FDA | +37 days |
| 28 Jan 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Mazor X robotic guidance system REF: TPL0059
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.
Questions about this recall
Why was it recalled?
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Which lots are affected?
Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mazor Robotics
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mazor recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Mazor X robotic guidance system recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Snapshot Tracker Kit, Mas2659-01, KIT0898 recalled by Mazor Robotics | Mazor Robotics | Other | 26 states |
| Device | CLASS II | Carousel MAS1025-01, part of the Brain Surgical Accessories recalled | Mazor Robotics | Other |
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