STAINLESS STEEL REPROCESSING TRAY — Class II medical device recall Z-2329-2020
Terminated recall by Intuitive Surgical, Inc., reported 2020-06-17, distributed nationwide. Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays a
| Recall number | Z-2329-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2019-12-19 |
| Classified | 2020-06-09 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2023-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 16 trays |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00886874115855 |
| Model numbers | 400499-03 |
Product
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.
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.
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-2329-2020. 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.