FDAClass IIMay 10, 2023

Steris Lighting and Visualization Systems recall

Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the…

Why was Steris Lighting and Visualization Systems 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the…
Recalling firm
Steris Corporation
Quantity
263,280 covers
Distribution
Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
Recall date
May 10, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls