CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
da Vinci Surgical System, IS recalled by Intuitive Surgical
Intuitive Surgical is recalling da Vinci Surgical System, IS 4000, distributed nationwide in the US. The recall was initiated on 17 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0283-2021
- FDA event ID
- 84963
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2019
- FDA classified
- 23 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Surgical Instruments
Timeline
| 17 Jun 2019 | Recall initiated by company | |
| 23 Oct 2020 | Classified by FDA | +494 days |
| 4 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Where it was distributed
US Nationwide distribution including in the state of Washington.
Questions about this recall
Is da Vinci Surgical System, IS 4000 recalled?
Yes. Intuitive Surgical recalled da Vinci Surgical System, IS 4000 on 17 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-0283-2021.
Why was it recalled?
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Which lots are affected?
IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137
Where was it sold?
US Nationwide distribution including in the state of Washington.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Intuitive Surgical
All 256| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical | Intuitive Surgical | Other | Nationwide |
| Device | CLASS II | Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | 49 states |
| Device | CLASS I | Intuitive SureForm 30 Gray Reloads Reference Numbers recalled | Intuitive Surgical | Other | 49 states |
| Device | CLASS II | Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled | Intuitive Surgical | Device Malfunction | Nationwide |
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