Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1118-2015·Announced 2015-02-25

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.

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 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…
Manufacturer: Intuitive Surgical, Inc.
Category: Medical Device — Surgical Instrument
Hazard: mis-labeling
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.

See all 2 products in this recall →

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · mis labeling