Facility

LUMICELL, INC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3017718237
Establishment type	Manufacture Medical Device
Location	307 Waverly Oaks Rd Ste 309 Waltham, MA, US 02452
Registration status	Active · expires 2026
Parent company	Lumicell, Inc (owner-operator 10090701)
Brand names	Lumicell Direct Visualization System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Fluorescence Imaging For Breast Cancer Detection
Product code SAW (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2025-07-31
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 inspections (1)

VAI2023-08-18
Voluntary Action Indicated · Bioresearch Monitoring · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Lumicell, Inc

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LUMICELL, INC (FEI 3017718237) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017718237-lumicell-inc/

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