Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use
Intuitive Surgical is recalling 12,467 Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.
What this means for you
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 involves a labeling error regarding manual operation of a surgical instrument. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Intuitive Surgical, Inc. is recalling 12,467 units of the Harmonic Ace Curved Shears Instructions for Use (IFU), 8MM, IS2000/IS3000. The recall covers product numbers 400275, 420275, and 420272. These instructions are intended for use with the da Vinci Surgical System - IS2000 and IS3000.
The recall was initiated after an internal labeling review determined that the IFU incorrectly instructs the user on how to manually open the grips. The affected units were 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.
Healthcare providers and facilities should contact Intuitive Surgical, Inc. for further instructions regarding the replacement or correction of the labeling.
The recalled product
- Product
- HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surg
- 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 400275
- 420275
- 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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