FDA Medical Device Recalls (openFDA)
Quasar Bio-Tech, Inc.: Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
- Recall number
- Z-2975-2018
- Recalling firm
- Quasar Bio-Tech, Inc.
- Product
- Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
- Status
- Terminated
- Initiated
- 2018-06-29
- Posted
- not on file
- Terminated
- 2019-08-27
- Reason
- Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
- Root cause
- Under Investigation by firm
- Action
- Quasar Bio-Tech notified customers on about 06/20/2018 via URGENT PRODUCT RECALL letter. Instructions included place any current, affected inventory on hold and arrange for return to Quasar Bio-Tech, Inc. Customers were also instructed to complete and return the reply form. Questions or concerns should be directed to Quasar Bio-Tech, Inc., at 800-944-1523 or 941-306-5812.
- Quantity
- 6,783 units total
- Distribution
- Nationwide distribution to CA, FL, GA, HI, IL, LA, MD, NE, NY, OH, TX, VA, WA, WI. Worldwide distribution to Australia, China, Netherlands, United Kingdom
- Lot, serial or model codes
- Product Number DPA-026. UPC Code 0 91037 46140 7
- 510(k) numbers
- ["K130225"]
- PMA numbers
- not on file
- Product code
- OHS
- Firm FEI
- 3006182559
- Firm city
- Sarasota
- Firm state
- FL
- 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