CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
LightStrike Blackout Curtains, Part numbers recalled
Xenex Disinfection Services is recalling LightStrike Blackout Curtains, Part numbers, distributed nationwide in the US. The recall was initiated on 18 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1615-2024
- FDA event ID
- 94258
- Recalling firm
- Xenex Disinfection Services, San Antonio, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Mar 2024
- FDA classified
- 23 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Mar 2024 | Recall initiated by company | |
| 23 Apr 2024 | Classified by FDA | +36 days |
| 1 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIdahoIllinoisKentuckyLouisianaMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNevadaOhioOklahomaOregon
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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