Intuitive Surgical, Inc.: 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.

Is my product affected?

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.

• UPC 00886874115855

Check against the official notice below — it lists the full affected range.

What happened

Intuitive Surgical, Inc. is recalling stainless steel reprocessing trays (Model No. 400499-03) used with 8 mm endoscope and handheld camera sterilization equipment. The trays have small but detectable holes in their sterilization wrap that could compromise sterility and create a risk of infection. Certain features of the trays combined with handling and storage practices may cause these holes to form. A total of 16 trays have been distributed worldwide, including across most U.S. states.

The recall affects all batch numbers of the affected model, identified by UDI 00886874115855. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: 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, Ok Quantity: 16 Trays Lot/code info: Model No. 400499-03; All Batch Numbers; UDI: 00886874115855

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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