Intuitive 8 mm SureForm 30 Gray Reloads Recall
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,068 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to May 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.