FDA Medical Device Recalls (openFDA)
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 number
- Z-1821-2008
- Recalling firm
- Psi Health Solutions
- 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).
- Status
- Terminated
- Initiated
- 2007-04-26
- Posted
- 2008-09-02
- Terminated
- 2008-12-18
- Reason
- Product was marketed before its 510(k) application cleared.
- Root cause
- PMA
- Action
- 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.
- Quantity
- 21000 units
- Distribution
- Product was distributed to approximately 21,000 consumers and retailers throughout the US.
- Lot, serial or model codes
- all codes and devices manufactured between June 22 to December 20, 2006.
- 510(k) numbers
- K070766
- PMA numbers
- not on file
- Product code
- MVV
- Firm FEI
- 3006236731
- Firm city
- Pacific Grove
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28