Mazor Robotics Ltd FDA Record

Summary

FDA record by year

Mazor Robotics Ltd's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Mazor Robotics Ltd above. Medtronic is the parent company.

Recent recalls

5 recall records from Nov 26, 2014 to Dec 10, 2025.

Recent 510(k) clearances

13 510(k) clearances from Apr 28, 2011 to Sep 11, 2025.

Mazor Robotics Ltd and the FDA: common questions

Has Mazor Robotics Ltd received an FDA warning letter?

No FDA warning letter addressed to the name "Mazor Robotics Ltd" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Mazor Robotics Ltd received an FDA Form 483?

FDA has not published a Form 483 for "Mazor Robotics Ltd" in its reading room. FDA publishes some Form 483s, not all of them.

Has Mazor Robotics Ltd had an FDA recall?

Yes. Mazor Robotics Ltd has 5 FDA recalls on record. The most recent under this name started Dec 10, 2025. A newer recall, dated Sep 24, 2026, is filed under the related name Medtronic.