The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2101-2012·Announced 2012-08-08

Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues

Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgical procedures.

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 source text describes a functional defect (difficulty engaging an instrument) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Intuitive Surgical, Inc. is recalling specific lots of the Instrument Arm Drapes IS2000, 20 Pack. The recall involves 92,390 total instrument drapes that were distributed worldwide, including in the United States, Australia, Spain, India, Italy, and Saudi Arabia.

The recall was initiated because the sterile adaptor on the affected drapes may have difficulty engaging an instrument. The intended use of these drapes is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

The affected product is identified by Part number 420015-03 and the following lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955, and DA121075. Healthcare facilities and users should check their inventory for these specific lot numbers and contact the manufacturer for instructions on how to proceed.

The recalled product

Product
INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Drapes
Hazard
Affected units
92,390

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 (8)

  • Part number: 420015-03
  • Lot numbers: D120745A
  • D120765
  • D120795
  • D120845
  • D120895A
  • D120935
  • D120955. EXPANDED - added lot DA121075.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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