Due to products not having FDA Premarket authorization to be distributed within the United States.
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Recall Number
Z-1133-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-19
Reported
2026-01-28
Distribution
The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.
Code Info
Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.