KIT — Class II medical device recall Z-2102-2012
Terminated recall by Intuitive Surgical, Inc., reported 2012-08-08, distributed nationwide. Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty e
| Recall number | Z-2102-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2012-07-13 |
| Classified | 2012-07-27 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, ES, IN, IT, SA |
| Quantity | 92,390 instrument |
| Reason classes | sterility |
| Lot numbers | D120745, D120755, D120835, D120865 |
| Model numbers | 420256-01 |
Product
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Reason for recall
Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
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-2102-2012. 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.