FDA Medical Device Recalls (openFDA)
Fisher Wallace Laboratories Inc.: Fisher Wallace Stimulator Models FW-100 and FW-200
- Recall number
- Z-1600-2023
- Recalling firm
- Fisher Wallace Laboratories Inc.
- Product
- Fisher Wallace Stimulator Models FW-100 and FW-200
- Status
- Open, Classified
- Initiated
- 2023-04-06
- Posted
- 2023-05-17
- Terminated
- not on file
- Reason
- If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 43,489 total devices
- Distribution
- US Nationwide. Global Distribution.
- Lot, serial or model codes
- FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T
- 510(k) numbers
- ["K903654"]
- PMA numbers
- not on file
- Product code
- QJQ
- Firm FEI
- 3006258094
- Firm city
- not on file
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28