Steris Lighting and Visualization Systems, Sterile Light… recallZ-1476-2023 · Steris Corporation · initiated Mar 17, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Under Investigation by firm

What the company is doing

Steris issued Urgent Medical Device Recall Letter on 3/17/23 via FedEx. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. For the full list of lots affected by this recall, please reference Attachment A to this letter. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. If product was transferred to any other entities within your organization, please forward this recall notice accordingly. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: [email protected] or via fax to (440) 392-8963. Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. If you have questions regarding this recall, please contact STERIS Customer Service at 1-800-548-4873, or email the RMA Team at [email protected].

Recall details

Recall number: Z-1476-2023
Status: Open, Classified
Initiated by the company: Mar 17, 2023
Posted by the FDA: Apr 28, 2023
Recalling firm: Steris Corporation
Quantity: 263,280 covers
Product code: FTA
Distribution: Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.

Product description

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

Code information (models, lots, serial numbers)

GTIN number: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

NA Lighthandle Cover
Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92040).

Z-1475-2023 · Open, Classified
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit ov…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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