Home / Recalls / Medical Devices
Intuitive Surgical, Inc. recalls STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable
Recalled June 17, 2020 · FDA recall Z-2329-2020 · Intuitive Surgical
Hazard
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes. · FDA Class II
Units
16 Trays
Sold at
Worldwide distribution - US Nationwide distribution including in the states of Arkansas, Arizona, Alabama, Alaska, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Idaho, Kentucky, Kansas, Louisiana, Missouri, Michigan, Maryland, Mississippi, Minnesota, Montana, Maine, Massachusetts, Nevada, New York, North Dakota, Nebraska, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington and West Virginia. Multiple countries including Canada.
Description
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
Product
STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →