Agency classClass IIOur severity:High FDA (Devices)·Z-1475-2023·Announced 2023-05-10

Steris surgical light handle covers may detach during procedures

Steris surgical light handle covers may detach during use, risking contamination of the sterile field and patient injury. The FDA is recalling approximately 1.4 million affected covers.

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 recall with a theoretical hazard (product detachment) that could result in patient injury, but no illnesses or hospitalizations have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High.

Plain-English summary

Steris Corporation is recalling Steris Lighting and Visualization Systems Sterile Light Handle Cover (LB53), a surgical light handle cover designed to be placed over surgical light handles for sterile surgeon control. The recall affects approximately 1,358,520 covers with multiple lot numbers ranging from 9604187 to 9799108.

The handle covers may separate and detach from the light handle during surgical use. When this occurs, it could delay the surgical procedure and compromise the sterile field, potentially resulting in patient injury.

The affected covers have been distributed worldwide, including throughout the United States, Puerto Rico, Canada, and Australia.

Steris Corporation and the FDA recommend that surgical facilities check their inventory for affected lot numbers and discontinue use of the product immediately. Healthcare providers should contact Steris directly for instructions on replacement or returns.

The recalled product

Product: 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
Manufacturer: Steris Corporation
Category: Medical Device — Surgical Lighting Equipment
Hazard: product-separation
sterile-field-contamination
injury-risk
Affected units: 1,358,520

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Steris Corporation

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Same hazard · product separation