The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1476-2023·Announced 2023-05-10

Steris Light Handle Covers May Detach During Surgical Use

Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.

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 involving a surgical device with risk of compromised sterile field and potential patient injury. However, no hospitalizations or reported injuries are documented in the source material, placing it in the 'risk-of-harm products where injury has not yet been reported' category per the severity rubric.

Plain-English summary

Steris Corporation is recalling 263,280 Sterile Light Handle Covers (model LB44) used with STERIS surgical lighting systems. The covers may separate or detach from the light handle during surgical procedures, which could delay the procedure and compromise the sterile field—a critical requirement in operating room safety.

The affected covers were distributed worldwide, including to healthcare facilities across the United States, Puerto Rico, Canada, and Australia. Affected lot numbers include 9943616, 9943616A, 9943617, 9943617A, 9943619, 9943619A, 9943620, 9943620A, 9959650, 9959650A, 9959651, and 9959651A.

If you use these covers, stop use immediately and contact Steris Corporation for replacement covers. A compromised sterile field during surgery could result in patient injury. Healthcare facilities should identify affected units by checking the lot number printed on the cover and withdraw them from use.

The recalled product

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
Manufacturer
Steris Corporation
Category
Medical Device — Surgical Lighting
Hazard
Affected units
263,280

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 →

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