Mazor Robotics Ltd

Complete recall history across all FDA and CPSC categories — 5 total recalls

Mazor Robotics Ltd appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Mazor Robotics Ltd

Date Product Reason Class
Dec 10, 2025 Mazor X robotic guidance system REF: TPL0059 Software errors that can result in incorrect surgical instrument positioning ... Class II
Jul 17, 2024 Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Software anomalies which can result in two separate issues: A lagging screen ... Class II
Sep 5, 2023 MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 ... Software update Class II
Jul 2, 2019 Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 0729010... The firm has become aware that the Snapshot Trackers were not manufactured i... Class II
Nov 26, 2014 Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative K... In some situations the carousel position pin (locker) may cause the carousel ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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