Steris Corporation: Medical Device Recall in 2023 - (Recall #: Z-1476-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.
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

Product Classification:

Class II

Date Initiated: March 17, 2023
Date Posted: May 10, 2023
Recall Number: Z-1476-2023
Event ID: 92040
Reason for Recall:

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

Status: Ongoing
Product Quantity: 263,280 covers
Code Information:

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

Distribution Pattern:

Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.

Voluntary or Mandated:

Voluntary: Firm initiated