Health Directions, Inc HealthPax (HP-1). Cranial Electrotherapy Stimulator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HealthPax (HP-1). Cranial Electrotherapy Stimulator
Brand
Health Directions, Inc
Lot Codes / Batch Numbers
HealthPax (HP-1)
Products Sold
HealthPax (HP-1)
Health Directions, Inc is recalling HealthPax (HP-1). Cranial Electrotherapy Stimulator due to Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
Recommended Action
Per FDA guidance
The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, MA, NJ, NY, PA, TX, WA
Page updated: Jan 10, 2026