Use cautionMedical device recall · FDA · Published March 17, 2023
Steris Surgical Light Handle Covers May Detach During Use - Risk of Procedure Delay
Steris recalls surgical light handle covers (LB53) that may detach during procedures, risking patient injury due to compromised sterile field. Affected units include specific lot numbers from 2023.
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
“Steris Surgical Light Handle Covers May Detach During Use - Risk of Procedure Delay.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58745-steris-surgical-light-handle-covers-may-detach-during-use-risk. Based on FDA recall #Z-1475-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1475-2023%22&limit=1).
The FDA announced on March 17, 2023, that Steris Corporation is recalling Steris Lighting and Visualization Systems, specifically the Sterile Light Handle Cover (LB53), because the covers may separate from the light handle during use. This detachment could delay procedures or impact the sterile field, potentially resulting in patient injury.
Distribution: Worldwide including US Nationwide (Puerto Rico), Canada, and Australia
The hazard
The light handle covers may separate from the light handle during use. This could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient.
Context
GovInfoNow's records show Steris Corporation has 29 other recalls on record since June 15, 2017. Other recent recalls of similar products include Steris HarmonyAIR A-Series Surgical Lights (May 15, 2026), Steris - Steris Corporation (May 15, 2026), and Steris AMSCO 7052HP Washer/Disinfector Recall (Nov. 19, 2025). Other recent recalls of similar products include Merit Medical Vascular Tray Recall (Dec. 4, 2025), Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025), and Stryker CHROMOPHARE Softlit Ring Surgical Light Recall (Feb. 23, 2026).
How to tell if you have this one
Check for Steris surgical light handle covers labeled 'LB53' with lot numbers from 9604187 to 9799107A. These covers were sold in 2023 and are used in operating rooms.
Brand
Steris
Product
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
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; GTIN number: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A
263,280 covers
Based on the official FDA remedy
What to do — step by step
Check for Detachment
Inspect the light handle cover for signs of separation from the surgical light handle.
Replace Cover
Replace the cover with a new one that is securely attached to the surgical light handle.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1475-2023 (March 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1475-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.