# FDA recall Z-1476-2023

> **Steris Corporation** · Class II · device recall initiated 2023-03-17.

## Product

Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44   -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment.  REF: LB44

## Reason for recall

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

## Distribution

Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.

## Key facts

- **Recall number:** Z-1476-2023
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-17
- **Report date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1476-2023

## Citation

> AI Analytics. FDA recall Z-1476-2023. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1476-2023. Source: US FDA. Licensed CC0.

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