Intuitive 8 mm SureForm 30 Gray Reloads Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Intuitive Surgical, Inc. is recalling Intuitive 8 mm SureForm 30 Gray Reloads (ref. 48230M-05 and 48230M-06) because they may produce an incomplete staple line.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 27, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Intuitive Surgical, Inc. initiated a voluntary recall of certain surgical stapler reloads after determining they may potentially produce an incomplete staple line.

Which Products Are Affected

  • Product: Intuitive 8 mm SureForm 30 Gray Reloads
  • Reference Numbers: 48230M-05 and 48230M-06
  • UDI: 00886874121931 (all serial numbers)
  • Recall Number: Z-1855-2026
  • Distribution: United States (all states) and select countries including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom
  • Classification: Class I
  • Status: Ongoing

What You Should Do

Healthcare facilities and providers should stop using the affected products and contact Intuitive Surgical, Inc. for return or replacement instructions. The recall was initiated via email on March 11, 2026.

Why This Matters

An incomplete staple line during surgery could lead to serious adverse health consequences.

Source

FDA Enforcement Report, recall number Z-1855-2026 (https://www.fda.gov)

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Intuitive Surgical, Inc. is recalling Intuitive 8 mm SureForm 30 Gray Reloads (ref. 48230M-05 and 48230M-06) because they may produce an incomplete staple line.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.