Recall Record

Tucson, AZ, United States

Spectral Instruments Inc recalls

2 recalls recorded since 2018, most recently on 24 July 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
24 July 2026
Reason
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Distribution
United States.
Initiated
FDA Mandated
Recall numbers
Z-2939-2026, Z-2940-2026

Ongoing Class II Medical devices

Recall started
13 May 2025
Reason
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Distribution
US
Initiated
FDA Mandated
Recall numbers
Z-1942-2025, Z-1941-2025

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.