FDA Medical Device Recalls (openFDA)
XENEX Disinfection Services Inc.: LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
- Recall number
- Z-1615-2024
- Recalling firm
- XENEX Disinfection Services Inc.
- Product
- LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
- Status
- Open, Classified
- Initiated
- 2024-03-18
- Posted
- 2024-04-23
- Terminated
- not on file
- Reason
- Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.
- Root cause
- Device Design
- Action
- On 3/18/24, correction notices were emailed to customers informing them of the following: 1) Blackout Curtains can continue to be used to block nuisance light coming from an unoccupied room/area where a UV cycle is being executed. It is not necessary to return curtains. 2) If your practice is to use this Blackout Curtain as a protective barrier, discontinue the use in occupied spaces. 3) If you may have further distributed this product, please identify your customers, and notify them at once of this product field correction or provide us with their contact information so the firm can reach out to them. Complete and return the response form. If you have any questions, call the firm at (830) 832-4299 between the hours of 8:00AM and 5:00PM CST Monday through Friday.
- Quantity
- 377
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, ID, IL, KY, LA, MI, MN, MO, NC, ND, NV, OH, OK, OR, TN, UT, WA, WV, WY.
- Lot, serial or model codes
- Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QXJ
- Firm FEI
- 3014531752
- Firm city
- San Antonio
- Firm state
- TX
- 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