Home / Brands / On-X Life Technologies
On-X Life Technologies Recalls
2 recalls on record · February 1, 2017 to May 20, 2026 · Medical Devices
Recalls by year
17
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 20, 2026Medical DevicesFDA
On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Hazard: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
February 1, 2017Medical DevicesFDA
On-X Life Technologies, Inc. recalls Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair
Hazard: Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptably press-fit together, was discovered within one sealed primary package. One of the Left Housing press-fit pins was not pressed into the associated hole of the Right Housing, resulting in a small gap in the housing assembly.