Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Steris Lighting and Visualization Systems Recalled by Steris Corporation Due to Light handle covers may separate from the light...

Date: March 17, 2023
Company: Steris Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Steris Corporation directly.

Affected 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

Quantity: 1,358,520 covers

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Steris Corporation

Steris Corporation has 109 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report