Lower riskMedical device recall · FDA · Published March 11, 2026
Intuitive 8 mm SureForm 30 Gray Reloads: Incomplete Stapes Risk
Intuitive Surgical recalls 8 mm SureForm 30 Gray Reloads (reference numbers 48230M-05 and 48230M-06) due to potential incomplete staple lines during use.
“Intuitive 8 mm SureForm 30 Gray Reloads: Incomplete Stapes Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49759-intuitive-8-mm-sureform-30-gray-reloads-incomplete-stapes-risk. Based on FDA recall #Z-1855-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1855-2026%22&limit=1).
Intuitive Surgical, Inc. voluntarily recalled Intuitive 8 mm SureForm 30 Gray Reloads on March 11, 2026, according to the FDA. The reloads may potentially produce an incomplete staple line.
How to tell if you have it
Brand: Intuitive Surgical
Product: Intuitive 8 mm SureForm 30 Gray Reloads
Reference Numbers: 48230M-05 and 48230M-06
UDI: 00886874121931/All serial Numbers
The hazard
The reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls of similar products include Medline Surgical Drapes Recall (Jan. 7, 2026), Medline 5.5" Sterile Scissors Recall (Nov. 13, 2025), and Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026).
How to tell if you have this one
Check for reference numbers 48230M-05 or 48230M-06 on the reloads. The product was sold with unique device identifiers (UDI) starting with 00886874121931.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for reference numbers 48230M-05 or 48230M-06 on the reloads.
Where it went and when
Where it was distributed
Distributed in 48 states and D.C., and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1855-2026 (March 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1855-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.