Mazor Robotics Recalls Carousel Accessories for Brain and Spinal Surgery Kits
Mazor Robotics is recalling five Carousel MAS1025-01 units used in brain and spinal surgery kits because the position pin may fail, causing the carousel to move inadvertently.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used during surgery where a mechanical failure could lead to patient harm, but the source text does not report any injuries or illnesses, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mazor Robotics Ltd is recalling five units of the Carousel MAS1025-01, which is part of the Brain Surgical Accessories Intra-operative Kit (KIT0295) and used with the Renaissance System (TPL0038). These accessories are indicated for the precise positioning of surgical instruments or spinal implants during general spinal and brain surgery.
The recall was initiated because, in some situations, the carousel position pin (locker) may cause the carousel upper plate to pop out. This failure can result in the carousel inadvertently moving during use. The affected products include all Carousels under Level 01, specifically associated with lots WP065611, WP066389, WP066411, WP066412, and WP066420.
The affected devices were distributed in the United States to four different medical facilities in four states. The source text does not report any specific injuries or illnesses associated with this defect. Medical facilities should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended…
- Manufacturer
- Mazor Robotics Ltd
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- WP066389
- WP066411
- WP066412
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Mazor Robotics Ltd
See all →- HighRobotic guidance systems recalled over incorrect surgical instrument positioning errors
FDA (Devices) · 2026-01-28
- HighMazor X Surgical Navigation Device Recalled for Software Display and Screw Tracking Errors
FDA (Devices) · 2024-09-25
- ModerateMedical Device Software Update Recall for 324 MAZOR X Surgical Robots
FDA (Devices) · 2023-10-18
- HighMazor Robotics Recalls Snapshot Tracker Kits Due to Manufacturing Defects
FDA (Devices) · 2020-01-01
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighRobotic guidance systems recalled over incorrect surgical instrument positioning errors
FDA (Devices) · 2026-01-28
- HighZimmer Biomet Recalls ROSA Brain Surgical Navigation Systems
FDA (Devices) · 2017-08-09
- CriticalSurgical Brain Guidance System Recalled for Inaccurate Electrode Placement
FDA (Devices) · 2021-11-03
- HighMazor Robotics Recalls Snapshot Tracker Kits Due to Manufacturing Defects
FDA (Devices) · 2020-01-01
- HighMazor X Surgical Navigation Device Recalled for Software Display and Screw Tracking Errors
FDA (Devices) · 2024-09-25
- SevereMedtronic Mazor X Surgical System Positioner Recalled for Detachment Risk
FDA (Devices) · 2020-06-17