Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly… — Class II medical device recall Z-2519-2025
Ongoing recall by Lumicell, Inc., reported 2025-09-10, distributed nationwide. The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As
| Recall number | Z-2519-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumicell, Inc., Newton, MA, United States |
| Recall initiated | 2025-07-31 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Lot numbers | 42756, 43930, 43931, 43932, 43933, 44349, 44349-01, 44349-02, 44349-03, 44349-04 |
| Model numbers | 900-00218 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2519-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.