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Lumicell, Inc. recalls Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper
Recalled September 10, 2025 · FDA recall Z-2519-2025 · Lumicell
Hazard
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. · FDA Class II
Units
200 units (20 packs containing 10 units per pack)
Sold at
US Nationwide distribution in the states of CA, FL, MA, NC, TX.
Description
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
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
Manufacturer(s)
Lumicell, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →