Recall Record

Wuxi, N/A, China

Wuxi Medical lnstrument Factory Co., Ltd. recalls

1 recall recorded since 2018, most recently on 12 February 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 Drugs

Recall started
12 February 2025
Reason
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Distribution
FL
Initiated
Voluntary: Firm initiated
Recall number
D-0247-2025

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.