Newton, MA, United States
Lumicell, Inc. recalls
1 recall recorded since 2018, most recently on 31 July 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 Medical devices
- Recall started
- 31 July 2025
- Reason
- The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.
- Distribution
- US Nationwide distribution in the states of CA, FL, MA, NC, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2519-2025
- Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software V
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.