PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 10, 2025 Initiated: July 31, 2025 #Z-2519-2025

Product Description

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.

Details

Recalling Firm
Lumicell, Inc.
Units Affected
200 units (20 packs containing 10 units per pack)
Distribution
US Nationwide distribution in the states of CA, FL, MA, NC, TX.
Location
Newton, MA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Lumicell, Inc.. Units affected: 200 units (20 packs containing 10 units per pack).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2519-2025.

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