Fisher Wallace Laboratories Inc. Fisher Wallace Stimulator Models FW-100 and FW-200 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fisher Wallace Stimulator Models FW-100 and FW-200
Brand
Fisher Wallace Laboratories Inc.
Lot Codes / Batch Numbers
FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000, FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T
Products Sold
FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T
Fisher Wallace Laboratories Inc. is recalling Fisher Wallace Stimulator Models FW-100 and FW-200 due to If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE CORRECTION dated 4/6/23 was sent to customers. Short term actions to be taken by the User: 1. Always ensure the batteries are inserted correctly into the device (see above diagram). 2. Do not leave batteries in the device when the device is not in use (e.g. in between a morning and evening treatment). 3. Do not fall asleep while using the device because corrective actions cannot be taken when the user is asleep. 4. If the device exhibits excess heat, burning smell, or odor, turn off the device, and discontinue use. Contact Fisher Wallace Laboratories immediately. The long term corrective action by the company is still being determined. We request your action by replying to this email to confirm that you understand the information in this medical device correction and the subsequent actions needed to be taken. Fisher Wallace apologizes for any inconvenience this may cause. If you have any questions about what to do with your product, please contact Fisher Wallace by telephone Monday - Friday, 10:00 AM to 6:00 PM, Eastern Time at (800) 692-4380 or by email at postmarketsurveillance@fisherwallace.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026