FDA Medical devices recall ·
900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name:… recall
- Recall number
- Z-2519-2025
- Date
- (initiated July 31, 2025)
- Company / brand
- Lumicell, Inc.
275 Washington St Ste 200, Newton, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 200 units (20 packs containing 10 units per pack)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
US Nationwide distribution in the states of CA, FL, MA, NC, TX.
States: California Florida Massachusetts North Carolina Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2519-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.