FDA Medical Device Recalls (openFDA)
Harris Medical Resources: Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"
- Recall number
- Z-1808-2010
- Recalling firm
- Harris Medical Resources
- Product
- Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"
- Status
- Terminated
- Initiated
- 2010-05-13
- Posted
- 2010-06-16
- Terminated
- 2010-12-10
- Reason
- The Harris UV Lamp was promoted for sub-lingual treatment of HIV/AIDS; Hepatitis B; Hepatitis C; Malaria, Typhoid, Amoeba Infections and other blood diseases. The product was marketed without a 510(k), or an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). Questions are directed to the firm at 773-583-7500.
- Root cause
- PMA
- Action
- Urgent Device Recall letters were sent registered, certified mail, return receipt requested, to the direct accounts on 5/13/10 - 5/18/10. The accounts were informed that Harris could make no claims as to the safety or efficacy of the Harris Medical UV Lamp in their possession and could recommend no medical indications for use because the necessary regulatory filings have not been completed and reviewed by the FDA, and that Harris Medical has no approved investigation clinical trials underway for the Harris Medical UV Lamp. The accounts were requested to check their inventory and quarantine any Harris Medical UV Lamps they may have in their possession and return them to Harris Medical using the enclosed pre-paid UPS shipping label. If the accounts further distributed the device, they were instructed to sub-recall them to the user level. The accounts were also requested to complete and return via mail or fax the enclosed return response form acknowledging the receipt and understanding of the recall letter and indicating the disposition of the devices. Any questions were directed to Thomas Perez at the company, at 773-583-7500.
- Quantity
- 20 units
- Distribution
- Florida, Hawaii, Ohio, Texas and internationally to Canada, Dominican Republic, Israel, Kenya and Peru
- Lot, serial or model codes
- All models, serial numbers and lot numbers are subject to this recall.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MXG
- Firm FEI
- 3007232259
- Firm city
- Chicago
- Firm state
- IL
- 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