Intuitive Surgical Recalls Unapproved da Vinci Thyroidectomy Promotional Literature
Intuitive Surgical is recalling promotional literature for the da Vinci Surgical System's thyroidectomy indication because the use was not approved with a 510(k) change.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves promotional literature and documentation issues rather than a physical product defect or direct health hazard, fitting the criteria for a Low severity score.
Plain-English summary
Intuitive Surgical, Inc. is recalling promotional literature related to the use of the da Vinci Surgical System for thyroidectomy procedures. The recall is being conducted because the thyroidectomy indication had not been approved with a change to the 510(k) submission.
The recalled items are marketing and promotional materials only. The source text does not indicate that the physical da Vinci Surgical System devices themselves are being recalled, only the specific literature promoting the unapproved thyroidectomy use.
The distribution pattern is listed as USA Nationwide distribution. The source text does not provide specific dates, lot numbers, or a count of affected units. Consumers and healthcare providers should stop using the promotional literature for the thyroidectomy indication and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,423
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- NA - marketing and promotional only.
Distribution
Distributed nationwide across the United States.
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