The Recall Desk
ModerateFDA (Devices)·Z-0233-2019·Announced 2018-10-31

Ecolab Recalls Disposable Accessory Kits for Da Vinci Robotic System

Ecolab Inc is recalling specific lots of Disposable Accessory Kits, 3-Arm, due to potential pouch seal defects that could compromise sterility.

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. The hazard is a potential breach in sterility due to packaging defects, which is a theoretical risk without reported illnesses or injuries in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Ecolab Inc is recalling 4,861 cases (24,305 individual units) of Disposable Accessory Kit, 3-Arm (Box of 5). These products are individually sealed in poly-Tyvek pouches and are intended for exclusive use on the Intuitive Surgical Da Vinci Si Robotic system. The affected lots include D173047, D173557, D173017, D180127, D172917, D180137, D172827, D172897, D180197A, D172757, D173037, D173557A, D180297, D172907, D180127A, D173207, D172847, D180397, D180037, D180287, D180267, D180197, D180277, D180417, D172787, D180047, D173057, D180407, D172797, D173567, D180477, and D180607.

The recall is being conducted 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 product is a single-use device intended to cover surgical and nonsurgical instruments to prevent cross-contamination.

The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous international countries such as Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, Ireland, Italy, Martinique, Netherlands, Norway, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and the United Kingdom. Healthcare facilities and users should check their inventory for the specific lot numbers listed and stop using the affected products.

The recalled product

Product
Disposable Accessory Kit, 3-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 420290-03 Lots # D173047
  • D173557
  • D173017
  • D180127
  • D172917
  • D180137
  • D172827
  • D172897
  • D180197A
  • D172757
  • D173037
  • D173557A
  • D180297
  • D172907
  • D180127A
  • D173207
  • D172847
  • D180397
  • D180037
  • D180287

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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