Recall Record

Solna, Sweden

Sonesta Medical AB recalls

1 recall recorded since 2018, most recently on 22 August 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
22 August 2025
Reason
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Distribution
US Distribution to NH only.
Initiated
Voluntary: Firm initiated
Recall number
Z-0460-2026

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.