Ecolab recalls sterile instrument arm drapes due to potential seal defects
Ecolab is recalling specific lots of sterile instrument arm drapes for the Da Vinci Si system because seal wrinkles may 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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a potential sterility breach rather than a confirmed high-risk pathogen or structural defect causing injury.
Plain-English summary
Ecolab Inc is recalling 344 cases (6,880 units) of Instrument Arm Drape (Box of 20) intended for use with the Intuitive Surgical Da Vinci Si Robotic system. The affected product is individually sealed in poly-Tyvek pouches and is distributed worldwide, including in the United States and numerous international markets.
The recall is due to a defect where certain lots of the product may have wrinkles along the pouch seal. These wrinkles could create a channel within the seal, potentially resulting in a breach in the sterility of the product. The affected lots are D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277 under Item 420015-03.
Healthcare facilities and distributors should stop using the affected product and contact Ecolab Inc for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap…
- 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 (7)
- Item 420015-03 Lots # D173357
- D173337A
- D180047A
- D180207
- D180057
- D180127A
- and D180277
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.
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