Z-0049-2025Class I

KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2...

Name: Z-0049-2025 KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2...
Creator: Kinova Inc
Published: 2024-08-22
License: https://open.fda.gov/license/

Kinova / initiated 2024-08-22 / Open, Classified / root cause: design

FDA source

Kinova Inc began a recall of 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 2024-08-22. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0049-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-08-22
Posted: 2024-10-11
Recalling firm: Kinova
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.
Product code: IQZ Hand, External Limb Component, Powered
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 949 units
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.
Product codes and lots: Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0049-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0049-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11

Product code IQZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)