Fisher Wallace Stimulator Models Recalled for Battery Overheat and Burn Risk
Fisher Wallace Stimulator Models FW-100 and FW-200 are being recalled because incorrectly installed batteries may cause the device to overheat, potentially resulting in burns. The recall affects 43,489 devices distributed nationwide and globally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm scenario where battery installation defects could lead to burns. No illnesses or injuries have been reported. The potential for burns classifies this as a High severity recall under the rubric for risk-of-harm products without reported injury.
Plain-English summary
Fisher Wallace Laboratories Inc. is recalling Fisher Wallace Stimulator Models FW-100 and FW-200, which are electrotherapy devices designed for medical use. The recall affects a total of 43,489 devices that were distributed nationwide across the United States and globally.
The devices may overheat if batteries are installed incorrectly. When overheating occurs, users may experience pain, discomfort, skin irritation, or burns during device use.
Consumers currently using these stimulators should verify that batteries are installed correctly according to the manufacturer's instructions. If you experience any pain, discomfort, or irritation while using the device, stop use immediately and contact Fisher Wallace Laboratories Inc. for further guidance.
The recalled product
- Product
- Fisher Wallace Stimulator Models FW-100 and FW-200
- Manufacturer
- Fisher Wallace Laboratories Inc.
- Category
- Medical Device — Neurostimulator
- Affected units
- 43,489
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- FW-100: UDI-DI 00860000919005
- Serial Numbers 2020200000-2022278000
- FW-200: UDI-DI 00860000919012
- Serial Numbers 2021140129T-2022030528T
Distribution
Distributed nationwide across the United States.
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