Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use
Intuitive Surgical is recalling Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error regarding manual operation instructions without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Harmonic Ace Curved Shears Instructions for Use (IFU), 5MM, IS1200. These instructions are intended for use with the da Vinci Standard Surgical System, which is used for soft tissue incisions when bleeding control and minimal thermal injury are desired.
The recall was initiated after an internal labeling review found that the IFU incorrectly instructs the user on how to manually open the grips. The affected product codes are PN 400274, 420274, and 420272. The quantity involved is 12,467 units across both sizes.
The product was distributed worldwide, including in the United States, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom. Users should contact Intuitive Surgical, Inc. for further instructions.
The recalled product
- Product
- HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 12,467
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 (3)
- PN 400274
- 420274
- and 420272.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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