Recall Record

Lakewood, CO, United States

Sensory Medical Inc recalls

1 recall recorded since 2018, most recently on 14 March 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.

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

Ongoing Class I Medical devices

Recall started
14 March 2022
Reason
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Distribution
U.S. Nationwide distribution to states including: AK, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA. MD, MI, MN, MO. MS. NC, ND, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, and WI; and O.U.S Internationally to: Canada
Initiated
Voluntary: Firm initiated
Recall number
Z-0918-2022

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.