Natural Rubber Latex QRG for the da Vinci Standard Surgical System — Class II medical device recall Z-1975-2014
Terminated recall by Intuitive Surgical, Inc., reported 2014-07-09, distributed nationwide. Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Rel
| Recall number | Z-1975-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-05-21 |
| Classified | 2014-07-01 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, IT, JP, KR, KW, LB, MX, MY, NL, NO, NZ, PH, PK, PT, QA, RO, RU, SA, SE, SG, SI, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 2,014 |
| Model numbers | 551997 |
Product
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Reason for recall
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
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-1975-2014. 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.