FDAFDA · Food and drugs·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 Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014
Published September 10, 2025 · Recall initiated: July 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Lumicell, Inc.
- Distributor
- US Nationwide distribution in the states of CA, FL, MA, NC, TX.
- Lot
- 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;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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