Recall Record

Cambridge, N/A, United Kingdom

CMR SURGICAL LIMITED recalls

1 recall recorded since 2018, most recently on 9 June 2026. 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
9 June 2026
Reason
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Distribution
US Nationwide distribution in the state of California.
Initiated
Voluntary: Firm initiated
Recall number
Z-2717-2026

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.