An FDA-recorded root-cause determination. The FDA lists 47 recalls with this root cause since 2025, 4 of them Class I (most serious). Most recent report: May 20, 2026.
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding…
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments.…
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury.…
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.