FDA Device recall 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/C…
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/C… by Lumicell, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2519-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-31 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Lumicell |
| Distribution | US |
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
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.
Identifiers
| code_info | Model/Catalog Number: 900-00218 UDI-DIs: Sterile Cover 10-Pack Shipper Box Assembly: (01)0 0860008 53781 2, 840-00204…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2519-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.