LightStrike Blackout Curtains Recalled Due to Inadequate UV and Ozone Protection
XENEX LightStrike Blackout Curtains are recalled due to inadequate protection against UV and ozone exposure. Bystanders in rooms during device operation may experience temporary skin reddening, eye irritation, nausea, and headache.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. The blackout curtains failed to provide adequate protection against UV and ozone exposure, creating a risk of temporary skin reddening, eye irritation, nausea, and headache. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without confirmed injury are rated High.
Plain-English summary
LightStrike Blackout Curtains (part numbers 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024) used with LightStrike Germ-Zapping Robot models PXUV4D, PXUV5D, LSMUV6-FT, and LSMUV6-SL are being recalled by manufacturer XENEX Disinfection Services Inc. These curtains, intended for whole-room microbial reduction, are no longer recommended as a protective barrier against UV and ozone exposure for bystanders in the same room during device operation.
Bystanders present in the room during a microbial reduction cycle may experience temporary skin reddening, a feeling of sand in the eyes, nausea, headache, and mucous membrane irritation. The recall involves 377 units distributed nationwide.
The recalled product
- 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.
- Manufacturer
- XENEX Disinfection Services Inc.
- Affected units
- 377
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Robot UDI-DIs: 00814122020033
- 00814122020064
- 00814122020125
- 00814122020132. All serial numbers.
Distribution
Related recalls
Same hazard · uv exposure
See all →- HighProSun Onyx 32 Sli Intensive Tanning Bed Recalled for UV Output Discrepancies
FDA (Devices) · 2019-04-24
- HighProSun V3 42 Tanning Beds Recalled for Potential High UV Output
FDA (Devices) · 2019-04-24
Other medical device recalls
- ModeratePentax Medical Ultrasound Endoscope Recall for Warning Label Updates
FDA (Devices) · 2026-11-04
- ModerateBoston Scientific Nalu Therapy Disc Firmware Defect Recall
FDA (Devices) · 2026-11-04
- ModerateBioMerieux EMAG System Recalled for Software Error Causing Delayed Results
FDA (Devices) · 2026-11-04
- ModeratePhilips Azurion 7 B20 Recalled for Unspecified Solid-State Drive Reliability Issues
FDA (Devices) · 2026-11-04
- ModerateMedtronic CareLink SmartSync RF Head Patient Connector Software Recall
FDA (Devices) · 2026-11-04
Similar recalls
- HighBard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects
FDA (Devices) · 2021-05-26
- HighLivaNova Perfusion Packs Recalled for Potential Leaks or Occlusions
FDA (Devices) · 2019-01-30
- HighBard Groshong NXT ClearVue Catheter Recalled for Connector Defects
FDA (Devices) · 2021-05-26
- HighGetinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns
FDA (Devices) · 2019-12-18
- HighBard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions
FDA (Devices) · 2018-05-16
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28