Recall Record

Plymouth, MN, United States

Incisive Surgical Inc recalls

1 recall recorded since 2018, most recently on 29 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
29 August 2018
Terminated
18 March 2019
Reason
Possible compromise of the sterile barrier integrity
Distribution
Israel
Initiated
Voluntary: Firm initiated
Recall number
Z-0078-2019

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.