Product Wiki · Recalls · U.S. FDA — Device Enforcement

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/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell

U.S. FDA — Device Enforcement · United States · 2025-07-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2519-2025
Date of alert: 2025-07-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Lumicell, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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