Z-1600-2023Class II

Fisher Wallace Stimulator Models FW-100 and FW-200

Name: Z-1600-2023 Fisher Wallace Stimulator Models FW-100 and FW-200
Creator: Fisher Wallace Laboratories Inc.
Published: 2023-04-06
License: https://open.fda.gov/license/

FISHER WALLACE LABORATORIES Inc / initiated 2023-04-06 / Open, Classified / root cause: manufacturing process

FDA source

Fisher Wallace Laboratories Inc. began a recall of Fisher Wallace Stimulator Models FW-100 and FW-200 on 2023-04-06. FDA classified it as Class II and gives the reason as "If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1600-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-06
Posted: 2023-05-17
Recalling firm: FISHER WALLACE LABORATORIES Inc
Product: Fisher Wallace Stimulator Models FW-100 and FW-200
Product code: QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 43,489 total devices
Distribution: US Nationwide. Global Distribution.
Product codes and lots: FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1600-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1600-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-17

Product code QJQ

K903654Class IILiss Cranial Stimulator Model Sbl202-BMedical Consultants Intl. , Ltd. / cleared 1990-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)