Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 3, 2020
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Intuitive Surgical, Inc. recalled da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. - a moderate-severity action.
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. was recalled by Intuitive Surgical, Inc. in June 3, 2020. Reason: Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may a…. Check the official notice for the remedy. Verify recall #Z-2131-2020 with the FDA Devices before acting.
The recall
Intuitive Surgical, Inc. issued this moderate-severity FDA Devices recall-Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may a….
- Moderate
- severity level
- 305 units
- affected scope
- Class II
- classification
- June 3, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2131-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2131-2020) was formally reported on June 3, 2020, with the manufacturer initiating the action on August 19, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Intuitive Surgical, Inc. is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records list the affected scope as 305 units.
The documented reason for this recall is: 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 modali… Distribution data in the federal record shows the product reached: Distribution US nationwide and South Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
305 units
Related Recalls
6
3 from same agency
Product description
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2131-2020 |
| Date reported | June 3, 2020 |
| Date initiated | August 19, 2019 |
| Recalling firm | Intuitive Surgical, Inc. |
| Firm location | Sunnyvale, CA |
| Affected scope | 305 units |
| Distribution | Distribution US nationwide and South Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2131-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.. Recalled by Intuitive Surgical, Inc.. Units affected: 305 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-2131-2020.
Where was the recalled product distributed? ▼
Distribution: Distribution US nationwide and South Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2131-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 3, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.