Class II — Lumicell, Inc.
| Recalling firm | Lumicell, Inc |
|---|---|
| Registered facility | LUMICELL, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 200 units (20 packs containing 10 units per pack) |
| Distribution | US Nationwide distribution in the states of CA, FL, MA, NC, TX. |
| Initiated | 2025-07-31 |
| Classified | 2025-09-04 |
| Recall number | Z-2519-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Lumicell, Inc. (Z-2519-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97316/
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