INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci… — Class II medical device recall Z-0340-2023
Ongoing recall by Intuitive Surgical, Inc., reported 2022-12-07, distributed in AZ, CA, CO, FL, IL, IN, LA, MA…. Potential staple deployment failure and device fragment generation
| Recall number | Z-0340-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2022-10-07 |
| Classified | 2022-11-30 |
| Reported by FDA | 2022-12-07 |
| Distributed | AZ, CA, CO, FL, IL, IN, LA, MA, MD, MI, MN, NC, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI |
| UPC / GTIN / UDI-DI | 10886874121723, 10886874121914, 10886874121921, 10886874121938 |
| Model numbers | 48230B, 48230M, 48230W, 488530 |
Product
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B
Reason for recall
Potential staple deployment failure and device fragment generation
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-0340-2023. 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.