EndoWrist SP recallZ-2131-2020 · Intuitive Surgical, Inc. · initiated Aug 19, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
FDA root cause category: Process control
What the company is doing
Urgent Medical Device Recall Letters (Field Safety Notices) were hand-delivered to U.S. customers on August 19, 2019 and OUS customers on August 20, 2019. Customers were asked to locate affected camera(s) in their inventory and inspect per the instructions attached to the Field Safety Notice throughout the life of the camera(s). If residual soil is present, customers were to return the affected camera(s) to the manufacturer using the standard Return Materials Authorization (RMA) process. Additionally, customers were requested to: iInform necessary hospital personnel about this issue; complete the attached Acknowledgement Form and return it via fax to Intuitive as instructed on the form; and to retain a copy of this letter and the Acknowledgement Form for their files. Customers were informed that an Intuitive Representative would schedule a site visit to review the attached inspection instructions, and that the firm will provide a replacement camera, at no charge, for returned affected product. Customers requiring further information or support may contact their Clinical Sales Representative or contact Intuitive Customer Service at the following numbers: US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or [email protected], or South Korea Customer Service: + 82-02-3271-3200, Option 3 ( 9AM to 6 PM KSTJ)
Recall details
- Recall number
- Z-2131-2020
- Status
- Open, Classified
- Initiated by the company
- Aug 19, 2019
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 305 units
- Product code
- NAY
- FDA submissions
- K173906
- Distribution
- Distribution US nationwide and South Korea.
Product description
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Code information (models, lots, serial numbers)
Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EndoWrist SP 430060Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall10 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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