Lower riskMedical device recall · FDA · Published June 10, 2020
Intuitive Surgical Ion Catheter Reprocessing Cover Recall: Risk of Cleaning Chemical
Intuitive Surgical recalls Ion Catheter Reprocessing Cover model IF1000 (Part 490114-02) due to potential cleaning chemical retention during reprocessing, which may cause system failure.
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
“Intuitive Surgical Ion Catheter Reprocessing Cover Recall: Risk of Cleaning Chemical.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65010-intuitive-surgical-ion-catheter-reprocessing-cover-recall-risk-of-cleaning. Based on FDA recall #Z-2949-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2949-2020%22&limit=1).
Intuitive Surgical, Inc. voluntarily recalled Ion Catheter Reprocessing Covers (PN 490114-02) on June 10, 2020, according to the FDA. The covers may become disengaged or incorrectly engaged, potentially causing system failure.
How to tell if you have it
Brand: Intuitive Surgical
Product: Ion Catheter Reprocessing Cover, IF1000
Part Number: 490114-02
UDI: 00886874116845
Lots: All lots
Quantity: 67 units
The hazard
One type of the ION Catheter Reprocessing Covers has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter. This can result in retention of cleaning chemical or water during reprocessing, which may cause failure of the ION Fully Articulating Catheter or ION System.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls include the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026) and the Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026). Similar recent recalls of reprocessed catheters include Medline Reprocessed Catheters (May 15, 2026), Medline ViewFlex Xtra ICE Catheters (Dec. 22, 2025), and Medline ReNewal Reprocessed Webster CS Catheters (Dec. 22, 2025).
How to tell if you have this one
Check for the model IF1000 with part number 490114-02 on the cover. All lots of this specific cover are affected.
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
Ongoing
Distribution
U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
Recall number
Product, codes & lots
Quantity
Z-2949-2020
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.; All lots.
67 units
Z-2950-2020
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).; All lots.
27 units
Based on the official FDA remedy
What to do — step by step
Check Cover Condition
Inspect the cover for signs of disengagement or incorrect engagement with the catheter.
Where it went and when
Where it was distributed
Distributed in 12 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2949-2020 (June 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2949-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.