None 400499Recalls & reported problems
Intuitive Surgical, Inc. · STAINLESS STEEL REPROCESSING TRAY,2D CAMERA HEAD,IS4000 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Dec 19, 2019Terminated
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.
Z-2329-2020 · Root cause: Device Design · FDA record ↗
Other Sterilization wrap containers, trays, cassettes & other accessories devices
- None 400498Intuitive Surgical, Inc. · Sterilization wrap containers, trays, cassettes & other accessories1 recall2 reports
- V. Mueller CD4-3STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-61B-PURPLECarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD3-4STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- AESCULAP US751Aesculap, Inc. · Sterilization wrap containers, trays, cassettes & other accessories50 reports
- V. Mueller CD5-3B-REDCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3C-PURPLECarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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