Class 2 Device Recall 90000218 Sterile Cover 10Pack Shipper Box Assembly

• Date Initiated by Firm: July 31, 2025
• Date Posted: September 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2519-2025
• Recall Event ID: 97316
• PMA Number: P230014
• Product Classification: Fluorescence imaging for breast cancer detection - Product Code SAW
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Lumicell, Inc.; 275 Washington St Ste 200; Newton MA 02458-1630
• For Additional Information Contact: 978-212-9554
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On July 31, 2025, URGENT: MEDICAL DECICE RECALL letters were sent to customers. Actions to be Taken by Customer: " Lumicell recommends that users dispose of the elastic bands and refrain from using them during the procedure. The Lumicell DVS may be used without elastic bands. " The elimination of elastic bands does not impact system performance. However, in the absence of elastic bands, there is a possibility that the secondary Sterile Probe Cover may shift during use. If this occurs, the Sterile Probe Cover may be repositioned, and Lumicell DVS use may continue. " If the included elastic bands are used, follow the Lumicell Direct Visualization System (DVS) Instructions for Use to ensure the bands are counted before and after the procedure to confirm the elastic bands are accounted for. " Please forward and post this notice for awareness to those who use it. If device was distributed or sold, please forward this notice to those accounts. " Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Please acknowledge receipt of this letter by completing the included response card. Next Actions: Lumicell is investigating the root cause of the issue and is working on a long-term solution. Lumicell will contact you in the future regarding updates. If you have any questions or need further assistance, please do not hesitate to reach out to our customer support team at 1-833-4-LUM-DVS (Monday through Friday, 9AM - 5PM Eastern Time) or email support@lumicell.com.
• Quantity in Commerce: 200 units (20 packs containing 10 units per pack)
• Distribution: US Nationwide distribution in the states of CA, FL, MA, NC, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = SAW