Psi Health Solutions Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).
Brand
Psi Health Solutions
Lot Codes / Batch Numbers
all codes and devices manufactured between June 22 to December 20, 2006.
Products Sold
all codes and devices manufactured between June 22 to December 20, 2006.
Psi Health Solutions is recalling Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 85957000 due to Product was marketed before its 510(k) application cleared.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was marketed before its 510(k) application cleared.
Recommended Action
Per FDA guidance
Recall imitated 04/26/07. Retailers were informed via phone and email and mail. The product was marketed prior to the firm receiving clearance to market from the FDA. Contact Carla Falcone at 831-373-7712 if you have questions.
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 noticePage updated: Jan 10, 2026