Open, Classified

KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.

FDA Recall Z-0049-2025 · Posted 2024-10-11

Recall StatusOpen, Classified

Product CodeIQZ

Date Initiated2024-08-22

Product Quantity949 units

Reason for Recall

Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.

Firm Action

On 07/22/2024, Kinova notified consignees via UGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed contact Kinova immediately for an assessment, ensure that if the wheelchair is in contact with a damaged part of the Jaco arm in any position at any time, to unplug the Jaco arm from the power source immediately and contact Kinova, and read the updated user guide on Kinova's website. Consignees were also requested to complete and return the acknowledgement and response form. Distributors were instructed to communicate the recall to all Jaco users, confirm receipt and understanding of the recall communication, maintain a detailed list of users, provide the user's contact details to Kinova, and perform an assessment for each user that response to the notification. Distributors were also instructed to complete and return the acknowledgement and response form.

Root Cause

Device Design

Distribution Pattern

Worldwide - US Nationwide distribution in the states of California, Missouri, North Carolina, Ohio and the countries of Australia, Canada, China, Czechia, France, Germany, Netherlands, Norway, Portugal, Switzerland, Great Britain, Northern Ireland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.