# FDA recall Z-1890-2020

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2019-07-01.

## Product

daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI:  00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

## Reason for recall

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line.  Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.

## Distribution

Worldwide distribution - US Nationwide including in the states of AL, AK, AZ, AR, CA, CO, CT, DE, D.C., FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI and the countries of Australia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-1890-2020
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-01
- **Report date:** 2020-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1890-2020

## Citation

> AI Analytics. FDA recall Z-1890-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1890-2020. Source: US FDA. Licensed CC0.

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