Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05… — Class I medical device recall Z-1855-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-05-13, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
| Recall number | Z-1855-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2026-03-11 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, BE, CH, DE, DK, ES, FI, FR, GB, IE, IT, JP, MX, NL, NO, SE |
| UPC / GTIN / UDI-DI | 00886874121931 |
Product
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reason for recall
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1855-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.