medical Class II Updated 2020-06-17

Intuitive Surgical, Inc. recalls STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Mo

Recalled Product

STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. 400498-02; All Batch Numbers; UDI: 00886874115848
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →