Recall Record: Class I Recall: Intuitive 8 mm SureForm 30 Gray Reloads Reference… by Intuitive Surgical, Inc.

Key facts

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Intuitive Surgical, Inc. and the affected product is described in FDA's record as: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06. FDA's stated reason for the recall is: Reloads for curved-tipped stapler may potentially produce an incomplete staple line.. The recall is tracked under FDA recall number Z-1855-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 -- and the recall number Z-1855-2026. If it matches, stop using or distributing it and contact Intuitive Surgical, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Intuitive Surgical, Inc.’s FDA history

Argus HQ has recorded 4 total FDA actions tied to Intuitive Surgical, Inc.: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA recall number for this event?

FDA recall number Z-1855-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Intuitive Surgical, Inc. recalled Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06. FDA's record states the reason for recall as: Reloads for curved-tipped stapler may potentially produce an incomplete staple line.. The recall is logged under FDA recall number Z-1855-2026 with a Class I classification.

Related enforcement actions