Recall Z-2519-2025— Lumicell, Inc.
Class II · Ongoing
Class II FDA medical device recall by Lumicell, Inc., initiated 2025-07-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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..
- Recalling firm
- Lumicell, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-31
- Firm location
- Newton, MA, United States
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.