Summary
The FDA issued a Class II for Fisher Wallace Stimulator Models FW-100 and FW-200 by Fisher Wallace Laboratories Inc.. Reason: If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of th.
Details
Source
Device Recall
External ID
Z-1600-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
Fisher Wallace Stimulator Models FW-100 and FW-200
Lot/Code Info: FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T
Quantity Affected: 43,489 total devices
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.
Distribution
US Nationwide. Global Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-06
Company
Brooklyn, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fisher Wallace Laboratories Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fisher Wallace Laboratories Inc. have FDA actions?
This is the only FDA action we have on record for Fisher Wallace Laboratories Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1600-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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