# FDA recall Z-0232-2019

> **Ecolab Inc** · Class II · device recall initiated 2018-09-14.

## 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.

## Distribution

Worldwide - US Nationwide Distribution in the states of AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, AND WY  In the countries of 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 United Kingdom

## Key facts

- **Recall number:** Z-0232-2019
- **Recalling firm:** Ecolab Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-14
- **Report date:** 2018-10-31
- **Termination date:** 2021-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2019

## Citation

> AI Analytics. FDA recall Z-0232-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0232-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*