Use caution Medical device recall · FDA · Published March 17, 2022

Intuitive Surgical da Vinci Xi Sureform 45 Recall: Tissue Pushout Risk

Intuitive Surgical recalls da Vinci Xi Sureform 45 and Curved-Tip models due to tissue pushout events causing bleeding risks during surgery. Affected units include specific model numbers and serial codes.

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

🇺🇸 FDA recall #Z-0999-2022Medical device Intuitive Surgical ›

Use caution until it’s fixed

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.

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 da Vinci Xi Sureform 45 surgical robots because they can push tissue distally instead of cutting it, leading to bleeding risks. This could cause serious bleeding during surgery if the device is used improperly. Read more at govinfonow.com/recall/60924-intuitive-surgical-da-vinci-xi-sureform-45-recall-tissue-pushout.

Source Summary by GovInfoNow · govinfonow.com/recall/60924-intuitive-surgical-da-vinci-xi-sureform-45-recall-tissue-pushout · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0999-2022

Cite this page

“Intuitive Surgical da Vinci Xi Sureform 45 Recall: Tissue Pushout Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60924-intuitive-surgical-da-vinci-xi-sureform-45-recall-tissue-pushout. Based on FDA recall #Z-0999-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0999-2022%22&limit=1).

The FDA announced on March 17, 2022, that Intuitive Surgical, Inc. is recalling da Vinci X and da Vinci Xi Sureform staplers due to a risk of critical bleeding. The agency stated the hazard exceeds predicted likelihoods documented in the company's risk files.

How to tell if you have it

Brand: Intuitive Surgical
Product: da Vinci X / da Vinci Xi Sureform 45 REF 480445
Product: da Vinci X / da Vinci Xi Sureform 45 Curved-Tip REF 480545
Product: da Vinci X / da Vinci Xi Sureform 60 REF 480460
UPC: 00886874117583
UPC: 00886874117590
UPC: 00886874115640
Lots: All Lots

The hazard

According to the FDA, tissue pushout events occur during firing when tissue is pushed distally within the jaws rather than being held in place. The agency reported that the overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive's existing risk documentation.

Context

GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls include the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026), the Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026), and the Da Vinci X and Xi Surgical Systems Recall (April 2, 2026). Other recent recalls of similar products include the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), the Olympus HX-400U-30 Ligating Device Recall (October 30, 2025), and the Katalyst Surgical DEX Ophthalmic Tissue Forceps Recall (March 25, 2026).

How to tell if you have this one

Check for model numbers: Sureform 45 (REF 480445), Sureform 45 Curved-Tip (REF 480545), or Sureform 60 (REF 480460). All units with these model numbers and serial codes are affected.

Brand
Intuitive Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Identify the model number on your device: Sureform 45 (REF 480445), Sureform 45 Curved-Tip (REF 480545), or Sureform 60 (REF 480460).

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico,…” 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, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 48 days after the firm started it.

Mar 17, 2022Firm started the recall
Apr 22, 2022FDA classified it Class II
May 4, 2022Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/60924-intuitive-surgical-da-vinci-xi-sureform-45-recall-tissue-pushout">Intuitive Surgical da Vinci Xi Sureform 45 Recall: Tissue Pushout Risk (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-0999-2022 (March 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0999-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.