Recall Z-1600-2023— Fisher Wallace Laboratories Inc.

Name: FDA recall Z-1600-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-06

Class II · Ongoing

Class II FDA medical device recall by Fisher Wallace Laboratories Inc., initiated 2023-04-06. It names one FDA 510(k) clearance: K903654. Product: Fisher Wallace Stimulator Models FW-100 and FW-200. 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..

Recalling firm: Fisher Wallace Laboratories Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-06
Firm location: Brooklyn, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K903654 — LISS CRANIAL STIMULATOR MODEL SBL202-BMedical Consultants Intl. , Ltd.·cleared 1990-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fisher Wallace Stimulator Models FW-100 and FW-200

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.