da Vinci S Surgical System IS2000 — Class II medical device recall Z-1382-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-04-15, distributed in PR. Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to te
| Recall number | Z-1382-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-03-16 |
| Classified | 2015-04-06 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2015-12-03 |
| Distributed | PR |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IS, IT, JP, KR, KW, LB, LU, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 442,475 all |
Product
da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Reason for recall
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
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-1382-2015. 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.