An FDA-recorded root-cause determination. The FDA lists 48 recalls with this root cause since 2025, 4 of them Class I (most serious). Most recent report: Jul 15, 2026.
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the…
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.
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.
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.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.