Lumicell, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2519-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 31, 2025

Date Posted: September 10, 2025

Recall Number: Z-2519-2025

Event ID: 97316

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.

Status: Ongoing

Product Quantity: 200 units (20 packs containing 10 units per pack)

Code Information:

Model/Catalog Number: 900-00218 UDI-DIs: Sterile Cover 10-Pack Shipper Box Assembly: (01)0 0860008 53781 2, 840-00204 Assy, Dispenser Carton Sterile Cover: (01)0 0860003 25251 2, 810-00210 Assy, Outer Tray Sterile Cover: (01) 0 0860003 2520 5, Lot numbers: 43930, 43931, 43932, 43933, 42756, 44349, 44349-01, 44349-02, 44349-03, 44349-04;

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, MA, NC, TX.

Voluntary or Mandated:

Voluntary: Firm initiated