The Recall Desk
HighFDA (Devices)·Z-0234-2019·Announced 2018-10-31

Ecolab Recalls Da Vinci Robotic System Disposable Accessory Kits

Ecolab is recalling specific lots of Disposable Accessory Kits for the Da Vinci Si Robotic system because wrinkles in the packaging seal could compromise sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile medical device where a packaging defect could breach sterility, posing a risk of harm (infection) even though no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Ecolab Inc is recalling 9,364 cases (46,820 individual units) of the Disposable Accessory Kit, 4-Arm (Box of 5), which is distributed by Intuitive Surgical for use exclusively on the Intuitive Surgical Da Vinci Si Robotic system. The affected product is individually sealed in poly-Tyvek pouches and is intended to cover surgical instruments and equipment to prevent cross-contamination.

The recall is being issued because the pouches of certain lots may have wrinkles along the pouch seal. These wrinkles could result in a channel within the seal, which may lead to a breach in the sterility of the product. The recall covers 58 specific lot numbers, including D173147, D173177, and D180507.

The affected product was distributed worldwide, including nationwide distribution in the United States and in 33 other countries. The source text does not report any illnesses or injuries associated with this recall. Users should check their inventory for the specific lot numbers listed in the recall notice and stop using the product if it matches the affected lots.

The recalled product

Product
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to co
Manufacturer
Ecolab Inc
Category
Medical Device — Surgical Drapes
Hazard

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 (20)

  • Item 420291-03 Lot # D173147
  • D173177
  • D173517
  • D173437
  • D173487
  • D172937
  • D173407
  • D173417
  • D173317
  • D180117
  • D180177
  • D173477
  • D180087
  • D173187
  • D173137
  • D172987
  • D173217
  • D173067
  • D173497
  • D173447

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Ecolab 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 4 products in this recall →

Related recalls

Same manufacturer · Ecolab Inc

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Same hazard · sterility breach

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