Intuitive 8 mm SureForm 30 Gray Reloads: Incomplete Stapes Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Intuitive Surgical is recalling specific 8 mm SureForm 30 Gray Reloads that may cause incomplete staple lines when used with curved-tipped staplers. This could lead to surgical complications if the staple line isn't properly formed.

Why it’s dangerous

The reloads may not form a complete staple line when used with curved-tipped surgical staplers. This could result in surgical complications if the staple line isn't properly formed during procedures.

Who’s affected

Surgical professionals using the recalled reloads for procedures involving curved-tipped staplers. The risk is primarily for those performing surgeries where precise staple lines are critical.

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.

✎ GovInfoNow

Questions people ask

What is the specific hazard with these reloads?

The reloads may produce an incomplete staple line when used with curved-tipped staplers, potentially causing surgical complications.

How can I tell if I have the recalled product?

Check for reference numbers 48230M-05 or 48230M-06 on the reloads. The product was sold with unique device identifiers (UDI) starting with 00886874121931.

What should I do if I have the recalled reloads?

The recall does not specify a remedy, so contact Intuitive Surgical directly for guidance.

Take action

Contact Intuitive Surgical

We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1855-2026 — Intuitive Surgical Intuitive Surgical

Hello,

I own a Intuitive Surgical that is covered by recall Z-1855-2026 from Intuitive Surgical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-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.

Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Lower-risk recall