Reported Apr 15, 2015 · Terminated

da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be…

Intuitive Surgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304

da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 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.

Lot codes and dates: Product number 420256-01
da Vinci S Disposable Accessory Kit
3 ARM
5 Pack
Lot Numbers for Cloudy/Waxy issueALL lot numbers
Lot Numbers numbers for Tear issue
D142205
D142275
D142345
D142375
D142625
D142695
D142765
D142835
D142905
D142975
D143035
D143115
D143175
D143255
D143315
D143385
D143445
D150085
D150215
D150295
D150365
D150435
D150515
D150575
D150655
Amount recalled: 442,475 total for all drape models

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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89 in total.