Recall StatusOpen, Classified
Date Initiated2025-10-13
Product Quantity314 batteries
Reason for Recall
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Firm Action
On or about 10/13/2025, the firm called customers and emailed an "URGENT MEDICAL DEVICE QUARANTINE" Letter to customer and distributers informing them that the firm has become aware of the possibility of the battery overheating during charging, resulting in melting of the internal components.
Customers and Distributors are instructed to:
1. Immediately discontinue use of the battery.
2. Do not charge the battery.
3. Remove the charger from the battery.
4. Label the battery and the light as BATTERY IN QUARANTINE, DO NOT USE
5. Keep the batteries in a secure location to avoid unintended use, and await further
instructions from MRI Med.
For Distributors are instructed to cease distribution of the affected products.
For Questions - contact MRI Med, Inc. Monday through Friday, 8:00am-3:00pm, PST, or email
[email protected] or via phone at 707-762-8600
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - U.S. Nationwide distribution in the states of AL, CA, PA, SC, GA, MA, TX, OH, NY, NC, IA, WA, TN, NJ, MO, LA, MN, AZ, VA, SC, KY, FL, MD, IN, AK, WI, NM, DC, RI, CT, CO, OK, DE, NE, MD, IL, NH and the countries of Germany, Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.