Lower riskMedical device recall · FDA · Published December 19, 2019
Intuitive Surgical Recalls Sterilization Trays Due to Sterility Risk
Intuitive Surgical recalls stainless steel reprocessing trays for 8mm endoscopes due to potential sterility breaches from small holes in sterilization wraps. Affected units include Model 400498-02 with all batch numbers.
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.
“Intuitive Surgical Recalls Sterilization Trays Due to Sterility Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66250-intuitive-surgical-recalls-sterilization-trays-due-to-sterility-risk. Based on FDA recall #Z-2328-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2328-2020%22&limit=1).
The FDA announced on December 19, 2019, that Intuitive Surgical, Inc. is recalling stainless steel reprocessing trays for its 8mm endoscope and IS4000 handheld camera sterilization trays due to potential sterility breaches. The hazard involves small holes in the sterilization wrap that could lead to infection risks.
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.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls include a Da Vinci 5 dV5 Tower NIR Handheld Camera recall on April 24, 2026, and an Intuitive Surgical Da Vinci Surgical System recall on April 22, 2026. Similar product recalls cited by Medline occurred on January 7, 2026, involving convenience kits and nerve block trays with sterility risks.
How to tell if you have this one
Check for the model number 400498-02 on the tray. All batch numbers are affected. The product is used in minimally invasive surgery procedures.
Brand
Intuitive Surgical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington and West Virginia. Multiple countries including Canada.
Recall number
Product, codes & lots
Quantity
Z-2328-2020
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.; Model No. 400498-02; All Batch Numbers; UDI: 00886874115848
1757 Trays
Z-2329-2020
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.; Model No. 400499-03; All Batch Numbers; UDI: 00886874115855
16 Trays
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model number 400498-02 and all batch numbers on the stainless steel reprocessing tray.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 44 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2328-2020 (December 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2328-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.