ION Reprocessing Accessories Kit — Class II medical device recall Z-2950-2020
Ongoing recall by Intuitive Surgical, Inc., reported 2020-09-16, distributed in CA, CO, FL, IL, MA, NC, NJ, NY…. One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or inco
| Recall number | Z-2950-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2020-06-10 |
| Classified | 2020-09-10 |
| Reported by FDA | 2020-09-16 |
| Distributed | CA, CO, FL, IL, MA, NC, NJ, NY, OH, PA, TX, VA |
| Quantity | 27 units |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 00886874119129 |
| Model numbers | 490024-03, 490114-02 |
Product
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2950-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.