FDA Device recall Z-1387-2015

da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 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 / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 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-1387-2015
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 / Si Surgical System IS2000 / IS3000, Instrument Arm 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

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Identifiers

code_info	Product number 420015-03; da Vinci S / Si Instrument Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot… Product number 420015-03; da Vinci S / Si Instrument Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142175, D142535, D142895, D143255, D150135A, D150555, DA142695A, DA143465A, D142175A, D142535A, D142895A, D143255A, D150145, D150555A, DA142725, DA143515, D142185, D142545, D142905, D143285, D150145A, D150565, DA142745, DA150075, D142185A, D142545A, D142905A, D143285A, D150155, D150565A, DA142745A, DA150085, D142195, D142555, D142915, D143295, D150155A, D150575, DA142755, DA150085A, D142195A, D142555A, D142915A, D143295A, D150165, D150575A, DA142755A, DA150125, D142205, D142585, D142935, D143305, D150165A, D150625, DA142765, DA150125A, D142205A, D142585A, D142935A, D143305A, D150195, D150625A, DA142795, DA150135, D142215, D142595, D142945, D143315, D150195A, D150635, DA142795A, DA150135A, D142235, D142595A, D142945, D143315, D150205, D150635A, DA142825, DA150195, D142235A, D142605, D142955, D143325, D150205A, D150645, DA142835,

code_info

Product number 420015-03; da Vinci S / Si Instrument Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot…

Product number 420015-03; da Vinci S / Si Instrument Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142175, D142535, D142895, D143255, D150135A, D150555, DA142695A, DA143465A, D142175A, D142535A, D142895A, D143255A, D150145, D150555A, DA142725, DA143515, D142185, D142545, D142905, D143285, D150145A, D150565, DA142745, DA150075, D142185A, D142545A, D142905A, D143285A, D150155, D150565A, DA142745A, DA150085, D142195, D142555, D142915, D143295, D150155A, D150575, DA142755, DA150085A, D142195A, D142555A, D142915A, D143295A, D150165, D150575A, DA142755A, DA150125, D142205, D142585, D142935, D143305, D150165A, D150625, DA142765, DA150125A, D142205A, D142585A, D142935A, D143305A, D150195, D150625A, DA142795, DA150135, D142215, D142595, D142945, D143315, D150195A, D150635, DA142795A, DA150135A, D142235, D142595A, D142945, D143315, D150205, D150635A, DA142825, DA150195, D142235A, D142605, D142955, D143325, D150205A, D150645, DA142835,

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-1387-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.