Home / Recalls / Intuitive Surgical, Inc. / Z-2328-2020

Z-2328-2020 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

FDA device recall Z-2328-2020 was initiated by Intuitive Surgical, Inc. on December 19, 2019 and is designated Class II. 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 r… The recall status is terminated (terminated August 31, 2023). Affected quantity: 1757 Trays.

Recall Details

Product Type
Devices
Report Date
June 17, 2020
Initiation Date
December 19, 2019
Termination Date
August 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1757 Trays

Product Description

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

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 Pattern

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.

Code Information

Model No. 400498-02; All Batch Numbers; UDI: 00886874115848

Other recalls by Intuitive Surgical, Inc.

  • Z-2310-2026 Class II — Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Numbe (April 24, 2026)
  • Z-2521-2026 Class II — Da Vinci ASSY, PSS, SP1098, Part Number: 380601 (April 22, 2026)
  • Z-2046-2026 Class II — Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical S (April 2, 2026)
  • Z-1855-2026 Class I — Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230 (March 11, 2026)
  • Z-1355-2026 Class II — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Numbe (December 30, 2025)
  • Z-1096-2026 Class II — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2. (December 15, 2025)
  • Z-1697-2026 Class II — Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: (December 9, 2025)
  • Z-1696-2026 Class II — Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: d (December 9, 2025)
  • Z-1699-2026 Class II — Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1700-2026 Class II — Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci (December 9, 2025)

FDA data resources