FDA-Device2023-05-10Class II
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
Hazard
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Sold states
Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
Affected count
1,358,520 covers
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1475-2023More Steris Corporation recalls
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for detachable control buttons
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for paint delamination
- FDA-Device2026-06-24Steris ALYON Surgical Lighting System recalled for detachable control buttons
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