Z-2519-2025Class II

Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover...

Name: Z-2519-2025 Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover...
Creator: Lumicell, Inc.
Published: 2025-07-31
License: https://open.fda.gov/license/

Lumicell, Inc. / initiated 2025-07-31 / Open, Classified

FDA source

Lumicell, Inc. began a recall of 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... on 2025-07-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2519-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-31
Posted: 2025-09-04
Recalling firm: Lumicell, Inc.
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
Product code: SAW Fluorescence Imaging For Breast Cancer Detection
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 root 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 [email protected].
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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2519-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2519-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-04

Product code SAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)