Lumicell, Inc.: Device Recall
Recall #Z-2519-2025 · 07/31/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2519-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Lumicell, Inc.
- Status
- Ongoing
- Date Initiated
- 07/31/2025
- Location
- Newton, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units (20 packs containing 10 units per pack)
Reason for Recall
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.
Product Description
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 Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014
Distribution Pattern
US Nationwide distribution in the states of CA, FL, MA, NC, TX.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.