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

Lot, batch or date codesSoftware versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

Quantity recalled549 systems

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.

Nationwide Puerto Rico

Questions about this recall

Is Mazor X robotic guidance system recalled?

Yes. Mazor Robotics recalled Mazor X robotic guidance system on 10 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1122-2026.

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?

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 21 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
25 Sep 2024Device	CLASS II	Mazor X recalled by Mazor Robotics	Mazor Robotics	Device Malfunction	Nationwide
18 Oct 2023Device	CLASS II	Mazor X robotic guidance system recalled by Mazor Robotics	Mazor Robotics	Device Malfunction	Nationwide
1 Jan 2020Device	CLASS II	Snapshot Tracker Kit, Mas2659-01, KIT0898 recalled by Mazor Robotics	Mazor Robotics	Lead & Heavy Metals	26 states
26 Dec 2018Device	CLASS II	Carousel MAS1025-01, part of the Brain Surgical Accessories recalled	Mazor Robotics	Other

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