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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Intuitive 8 mm SureForm 30 Gray Reloads Recalled for Incomplete Staple Line

Agency Publication Date: May 1, 2026
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Summary

Intuitive Surgical, Inc. is recalling its 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) used with curved-tipped staplers. These surgical components may potentially produce an incomplete staple line during medical procedures. Healthcare providers should identify any remaining stock and contact the manufacturer to arrange for the return or correction of the affected devices.

Risk

The reloads may fail to create a complete staple line during surgery, which could lead to internal leaking, bleeding, or the need for additional surgical intervention.

What You Should Do

  1. Identify if you have the Intuitive 8 mm SureForm 30 Gray Reloads by checking the reference numbers (48230M-05 and 48230M-06) and UDI (00886874121931) on the product packaging.
  2. Stop using the recalled product immediately.
  3. Contact Intuitive Surgical, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected reloads.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Intuitive 8 mm SureForm 30 Gray Reloads
Model / REF:
48230M-05
48230M-06
Serial Numbers:
All serial Numbers
UDI:
00886874121931

Used for curved-tipped stapler.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98525
Status: Active
Manufacturer: Intuitive Surgical, Inc.
Sold By: Hospitals; Surgical Centers
Manufactured In: United States
Distributed To: 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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.