Use caution Medical device recall · FDA · Published July 1, 2019

daVinci XI Sureform 60 Reload: Risk of incomplete staple line causing air leak

Intuitive Surgical recalls daVinci XI Sureform 60 Reload staples that may not deploy staples properly, risking air leaks during surgery. Affected units have specific lot numbers and are used in certain surgical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1891-2020Medical device Intuitive Surgical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd Bldg 101 · Sunnyvale, CA 94086-5304

✎ GovInfoNow plain-language explainer

Intuitive Surgical is recalling certain daVinci XI Sureform 60 Reload surgical staples that may not deploy individual staples correctly. This could lead to incomplete staple lines, potentially causing air leaks or requiring additional surgery. Read more at govinfonow.com/recall/67525-davinci-xi-sureform-60-reload-risk-of-incomplete-staple-line.

Source Summary by GovInfoNow · govinfonow.com/recall/67525-davinci-xi-sureform-60-reload-risk-of-incomplete-staple-line · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1891-2020

Cite this page

“daVinci XI Sureform 60 Reload: Risk of incomplete staple line causing air leak.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67525-davinci-xi-sureform-60-reload-risk-of-incomplete-staple-line. Based on FDA recall #Z-1891-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2020%22&limit=1).

The FDA announced on July 1, 2019, that Intuitive Surgical, Inc. is recalling daVinci XI Sureform Stapler Reloads due to a manufacturing variation that may prevent proper staple deployment. This defect could result in incomplete staple lines, potentially causing air or anastomotic leaks requiring additional intervention.

How to tell if you have it

Brand: Intuitive Surgical
Product: daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm
Ref: 48360T-08
UDI: 00886874113851
Lot numbers: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113

The hazard

The firm identified a manufacturing variation in which black and green reloads may not deploy individual adjacent staples, leading to incomplete staple lines. Such failures could potentially cause an air leak or an anastomotic leak that may require additional procedural intervention.

Context

GovInfoNow's records show Intuitive Surgical has issued 53 other recalls since June 1, 2017. Recent similar recalls include the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall on April 24, 2026, and the Intuitive Surgical Da Vinci Surgical System Recall regarding E-Brake Pin Risk on April 22, 2026. Other recent recalls of similar products include the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), the AVID Medical Halyard STANDARD LINE INSERTION PACK recall (May 19, 2026), and the Oscor Abiomed Introducer Kit Recall (June 10, 2026).

How to tell if you have this one

Check for the product name 'daVinci XI Sureform 60 Reload', 60 mm black 6-Row 4.6 mm, Ref: 48360T-08, and UDI: 00886874113851. Affected units have specific lot numbers: T10180615, T10180924, T10181003, T10181010, T10181016, T10181029, T10181107, T10181109, T10181113.

Brand
Intuitive Surgical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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.

Recall number	Product, codes & lots	Quantity
Z-1890-2020	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.; Lot numbers: T10180511; T10180718; T10180821;T10180822; T10180906; T10180913; T10180925; T10181008; T10190204; T10190208; T10190213; T11180816; T11190219	22,752 reloads
Z-1891-2020	daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - 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.; Lot numbers: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113	N/A

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, model, and lot numbers listed in the recall notice to confirm if your staples are affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 10 months after the firm started it.

Jul 1, 2019Firm started the recall
May 5, 2020FDA classified it Class II
May 13, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Intuitive Surgical recalls

Link to this recall

<a href="https://govinfonow.com/recall/67525-davinci-xi-sureform-60-reload-risk-of-incomplete-staple-line">daVinci XI Sureform 60 Reload: Risk of incomplete staple line causing air leak (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1891-2020 (July 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1891-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.