FDA (Devices) recall action 70777

Intuitive Surgical, Inc. recalled 14 products on 2015-04-15

The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products: 14
Announced: 2015-04-15
Critical: 0
Units: 6,194,650

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–14 of 14

HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci Si Camera Head Drapes
Intuitive Surgical is recalling da Vinci Si Camera Head Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.
Product
da Vinci Si Surgical System IS3000, Camera Head 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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci Instrument Arm Drapes Due to Defects
Intuitive Surgical is recalling da Vinci S/Si Instrument Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci S Patient-Cart Monitor Drapes
Intuitive Surgical is recalling da Vinci S Patient-Cart Monitor Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.
Product
da Vinci S Surgical System IS2000, Patient-Cart Monitor 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci S Arm Drapes Due to Waxy Appearance
Intuitive Surgical is recalling da Vinci S Surgical System arm drapes due to a cloudy, waxy appearance that may transfer to patients or cause tearing.
Product
da Vinci S Surgical System IS2000, 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci S Camera Drapes Due to Waxy Appearance
Intuitive Surgical is recalling da Vinci S Camera Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.
Product
da Vinci S Surgical System IS2000, Camera 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Product
da Vinci Si Surgical System IS3000, 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Product
da Vinci Si Surgical System IS3000, 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci S Monitor Drapes Due to Waxy Appearance
Intuitive Surgical is recalling da Vinci S Vision-Cart Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.
Product
da Vinci S Surgical System IS2000, Vision-Cart Monitor 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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci Camera Arm Drapes for Defects
Intuitive Surgical is recalling da Vinci S/Si Camera Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.
Product
da Vinci S / Si Surgical System IS2000 / IS3000, Camera 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci S Camera Arm Drapes
Intuitive Surgical is recalling da Vinci S Camera Arm Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.
Product
da Vinci S Surgical System IS2000, Camera 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci Si Monitor Drapes Due to Waxy Appearance
Intuitive Surgical is recalling da Vinci Si Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.
Product
da Vinci Si Surgical System IS3000, Monitor 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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci Si Camera Arm Drapes
Intuitive Surgical is recalling da Vinci Si Camera Arm Drapes due to a cloudy appearance and potential to tear or transfer waxy substance to patients.
Product
da Vinci Si Surgical System IS3000, Camera 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.
Category
Distribution
1 state
HighFDA (Devices)··2015-04-15
Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a potential for the drape to tear.
Product
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.
Category
Distribution
1 state