On-X Life Technologies recalls

On-X Life Technologies has 2 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 20 May 2026. 1 is still ongoing. 1 was reported in the last 12 months.

Total recalls2since 2017

Last 12 months1reported

Class I00% of total

Ongoing1latest 20 May 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why on-x life technologies is recalled

Other Reasons150%
Particulate Matter150%

Product types

Heart & Vascular Devices150%
Surgical Instruments150%

By year

2026150%
2017150%

Ongoing on-x life technologies recalls

1 active

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	On-X Mitral Heart Valve with Conform-X Sewing Ring recalled	On-X Life Technologies	Other	Nationwide

All on-x life technologies recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	On-X Mitral Heart Valve with Conform-X Sewing Ring recalled	On-X Life Technologies	Other	Nationwide
1 Feb 2017Device	CLASS II	Chord-X Chordal Sizer is designed to assist recalled	On-X Life Technologies	Particulate Matter	7 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.