Camera Arm Drape — Class II medical device recall Z-0232-2019
Terminated recall by Ecolab Inc, reported 2018-10-31, distributed nationwide. The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel w
| Recall number | Z-0232-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecolab Inc, Saint Paul, MN, United States |
| Recall initiated | 2018-09-14 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2021-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, IE, IS, IT, NL, NO, SA, SE, SG, TH, TW, ZA |
| Reason classes | sterility, packaging |
| Lot numbers | D180437A, D180567 |
| Model numbers | 420279-03, D180437A, D180567 |
Product
Camera 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 / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
Reason for recall
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0232-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.