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.
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. 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…
- Manufacturer
- Ecolab Inc
- Category
- Medical Device — Surgical Drapes
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
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
See all →- HighEcolab Recalls Slush and Warmer Disc Drapes Due to Sterile Barrier Risk
FDA (Devices) · 2021-03-03
- ModerateEcolab Recalls Hand Sanitizer Due to Discoloration and Foreign Substance
FDA (Drugs) · 2020-09-02
- ModerateEcolab Recalls QUIK-CARE Hand Sanitizer Due to Incorrect Alcohol Ingredient
FDA (Drugs) · 2019-06-26
- ModerateEcolab Recalls Express Gel Hand Sanitizer Due to Chemical Contamination
FDA (Drugs) · 2019-04-03
- ModerateEcolab Moisturizing Gel Hand Sanitizer Recalled for Chemical Contamination
FDA (Drugs) · 2019-04-03
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighIntuitive Surgical Recalls da Vinci Si Disposable Accessory Kits
FDA (Devices) · 2015-04-15
- HighEcolab Recalls Disposable Light Handle Covers Due to Seal Gaps
FDA (Devices) · 2018-02-14
- HighIntuitive Surgical Recalls da Vinci S Disposable Accessory Kits
FDA (Devices) · 2015-04-15
- ModerateIntuitive Surgical Recalls da Vinci Si Camera Arm Drapes
FDA (Devices) · 2015-04-15
- HighIntuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
FDA (Devices) · 2012-08-08
- ModerateIntuitive Surgical Recalls da Vinci Xi Instrument Arm Drapes
FDA (Devices) · 2015-07-08