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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

XENEX Disinfection Services Inc.: LightStrike Blackout Curtains Recalled Due to UV and Ozone Exposure Risk

Agency Publication Date: April 23, 2024
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Summary

Xenex Disinfection Services is recalling approximately 377 LightStrike Blackout Curtains used with LightStrike Germ-Zapping Robots (Models PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL). The curtains are no longer recommended as a protective barrier because they may fail to block harmful UV/Ozone exposure to people standing on the other side of the curtain during a disinfection cycle. This recall affects various part numbers used for whole-room microbial reduction in medical and commercial settings.

Risk

Bystanders in the same room as an active disinfection cycle may be exposed to UV light and Ozone despite the curtain barrier, leading to temporary skin reddening, a sensation of sand in the eyes, nausea, headache, or irritation of the mucous membranes.

What You Should Do

  1. Identify if you have the affected LightStrike Blackout Curtains by checking for part numbers 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024.
  2. Verify if these curtains are used with LightStrike Germ-Zapping Robot models PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL with UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132.
  3. Immediately stop using these blackout curtains as a protective barrier for bystanders; ensure no persons are in the same room on either side of the curtain while a UV disinfection cycle is in progress.
  4. Contact Xenex Disinfection Services Inc. at their San Antonio, Texas headquarters or through your primary service representative to discuss alternative safety protocols or updated recommendations.
  5. If you have experienced symptoms such as skin reddening, eye irritation, or nausea following a disinfection cycle, contact your healthcare provider for guidance.
  6. For further questions regarding this medical device recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices.

Your Remedy Options

๐Ÿ“‹Other Action

Blackout curtains are no longer recommended as a protective barrier.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: LightStrike Blackout Curtains (Part 610-00008)
Model / REF:
610-00008
Used with Robot Models: PXUV4D, PXUV5D, LSMUV6-FT, LSMUV6-SL
Robot UDI-DI: 00814122020033
Robot UDI-DI: 00814122020064
Robot UDI-DI: 00814122020125
Robot UDI-DI: 00814122020132
Lot Numbers:
All serial numbers
Product: LightStrike Blackout Curtains (Part 610-00009)
Model / REF:
610-00009
Used with Robot Models: PXUV4D, PXUV5D, LSMUV6-FT, LSMUV6-SL
Robot UDI-DI: 00814122020033
Robot UDI-DI: 00814122020064
Robot UDI-DI: 00814122020125
Robot UDI-DI: 00814122020132
Lot Numbers:
All serial numbers
Product: LightStrike Blackout Curtains (Part 610-00019)
Model / REF:
610-00019
Used with Robot Models: PXUV4D, PXUV5D, LSMUV6-FT, LSMUV6-SL
Robot UDI-DI: 00814122020033
Robot UDI-DI: 00814122020064
Robot UDI-DI: 00814122020125
Robot UDI-DI: 00814122020132
Lot Numbers:
All serial numbers
Product: LightStrike Blackout Curtains (Part 610-00020)
Model / REF:
610-00020
Used with Robot Models: PXUV4D, PXUV5D, LSMUV6-FT, LSMUV6-SL
Robot UDI-DI: 00814122020033
Robot UDI-DI: 00814122020064
Robot UDI-DI: 00814122020125
Robot UDI-DI: 00814122020132
Lot Numbers:
All serial numbers
Product: LightStrike Blackout Curtains (Part 610-00024)
Model / REF:
610-00024
Used with Robot Models: PXUV4D, PXUV5D, LSMUV6-FT, LSMUV6-SL
Robot UDI-DI: 00814122020033
Robot UDI-DI: 00814122020064
Robot UDI-DI: 00814122020125
Robot UDI-DI: 00814122020132
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94258
Status: Active
Manufacturer: XENEX Disinfection Services Inc.
Sold By: Direct from manufacturer; Xenex Disinfection Services Inc.
Manufactured In: United States
Units Affected: 377
Distributed To: Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nevada, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.