FDA Medical devices recall ·
KINOVA Jaco assistive robot recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0049-2025
- Date
- (initiated August 22, 2024)
- Company / brand
- Kinova Inc
355 Peel St Suite 301, Montreal, Canada - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 949 units
- Hazard tags
- Fire
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. All lot numbers.
Distribution
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.
States: California Missouri North Carolina Ohio
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0049-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.