Z-1808-2010

Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or...

Name: Z-1808-2010 Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or...
Creator: Harris Medical Resources
Published: 2010-05-13
License: https://open.fda.gov/license/

Harris Medical Resources / initiated 2010-05-13 / Terminated

FDA source

Harris Medical Resources began a recall of 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... on 2010-05-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1808-2010
Status: Terminated
Initiated: 2010-05-13
Posted: 2010-06-16
Terminated: 2010-12-10
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"
Product code: MXG Lamp, Uvc, (For Treating Skin And Wounds)
Reason for recall: 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.
FDA 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 in commerce: 20 units
Distribution: Florida, Hawaii, Ohio, Texas and internationally to Canada, Dominican Republic, Israel, Kenya and Peru
Product codes and lots: All models, serial numbers and lot numbers are subject to this recall.

Product code MXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)