CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Intuitive SureForm 30 Gray Reloads Reference Numbers recalled

Intuitive Surgical is recalling Intuitive SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06, distributed in 49 states. The recall was initiated on 11 Mar 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI:00886874121931/All serial Numbers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1855-2026
FDA event ID: 98525
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class I
Status: Ongoing
Recall initiated: 11 Mar 2026
FDA classified: 1 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Mar 2026	Recall initiated by company
1 May 2026	Classified by FDA	+51 days
13 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

Product as listed by the FDA

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Where it was distributed

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 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 OUS: Austria Belgium Denmark Finland France Germany Ireland Italy Japan Netherlands Norway Spain Sweden Switzerland United Kingdom

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

Which lots are affected?

UDI:00886874121931/All serial Numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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