Lumicell, Inc. 2025-09-10 Health serious FDA
Health · FDA · Recall #FDA-Z-2519-2025
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218… Recall
Issued September 10, 2025 · Lumicell, Inc.
In September 2025, Lumicell, Inc. recalled the Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Lumicell, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Lumicell, Inc.
- Category
- Health
- Recall date
- September 10, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA, FL, MA, NC, TX.
- Recall number
- FDA-Z-2519-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Lumicell, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.