Intuitive Surgical, Inc. da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
Model Number: 430060-33, UDI Number: 00886874114384, All serial numbers.
Products Sold
Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
Intuitive Surgical, Inc. is recalling da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Customerservice@intusurg.com, or South Korea Customer Service: + 82-02-3271-3200, Option 3 ( 9AM to 6 PM KSTJ)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026