# FDA recall Z-2519-2025

> **Lumicell, Inc.** · Class II · device recall initiated 2025-07-31.

## 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.

## Distribution

US Nationwide distribution in the states of CA, FL, MA, NC, TX.

## Key facts

- **Recall number:** Z-2519-2025
- **Recalling firm:** Lumicell, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-31
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2519-2025

## Citation

> AI Analytics. FDA recall Z-2519-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-2519-2025. Source: US FDA. Licensed CC0.

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