Recall Record

Westminster, CO, United States

Cerapedics, Inc. recalls

2 recalls recorded since 2018, most recently on 29 December 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
29 December 2025
Reason
Incorrect expiration date
Distribution
US Nationwide distribution in the states of CA, CO, CT, FL, GA, ID, IL, KS, LA, MI, MN, MO, MT, NE, NJ, NV, NY, OH,OR, PA, TN, TX, WA, WY.
Initiated
Voluntary: Firm initiated
Recall number
Z-1165-2026

Terminated Class III Medical devices

Recall started
14 April 2022
Terminated
23 December 2024
Reason
Patient chart label contains incorrect Part Number and volume amount.
Distribution
U.S. Nationwide distribution in the states of AL, AZ, CA, CT, DC, DE, ID, IN, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, TX, VA, and WA.
Initiated
Voluntary: Firm initiated
Recall number
Z-1056-2022

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.