FDA Device recall Z-1906-2020
da Vinci SP Instrument Arm Drape
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of da Vinci SP Instrument Arm Drape by Intuitive Surgical, citing the instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1906-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-25 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | AL, CA, FL, HI, IL, MD, MN, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA |
Product
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Reason
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Identifiers
| code_info | Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1906-2020%22
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