FDA Device recall Z-1390-2015
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack
- FDA Device
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack by Intuitive Surgical, citing cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1390-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-16 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | PR |
Product
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 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
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Identifiers
| code_info | Product number 420258-01; da Vinci S Disposable Accessory Kit, 4 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: AL…Product number 420258-01; da Vinci S Disposable Accessory Kit, 4 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D141015R, D142205, D142275, D142345, D142485, D142625, D142685, D142765, D142835, D142905, D142965, D143035, D143105, D143175, D143245, D143315, D143385, D143445, D143515, D150085, D150155, D150215, D150295, D150365, D150435, D150515, D150575, D150655 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2015%22
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