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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70777

14 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 16, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intuitive Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

14 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 14

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.

Z-1380-2015
Recall number
Z-1380-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 400015-03; da Vinci (Standard System) Inst. Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 2 of 14

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.

Z-1381-2015
Recall number
Z-1381-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 400016-04; da Vinci (Standard System) Camera Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 3 of 14

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.

Z-1382-2015
Recall number
Z-1382-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 400027-04; da Vinci (Standard System) Camera Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 4 of 14

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.

Z-1383-2015
Recall number
Z-1383-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number420017-03; da Vinci (Standard System) Patient-Cart Monitor Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 5 of 14

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.

Z-1384-2015
Recall number
Z-1384-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420026-01; da Vinci S Vision-Cart Monitor Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 6 of 14

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.

Z-1385-2015
Recall number
Z-1385-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420273-02; da Vinci Si Camera Head Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 7 of 14

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.

Z-1386-2015
Recall number
Z-1386-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420281-02; da Vinci Si Monitor Drape, 20 Pack Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 8 of 14

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.

Z-1387-2015
Recall number
Z-1387-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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, DA150205, D142245, D142605A, D142955A, D143325A, D150215, D150645A, DA142835A, DA150205A, D142245A, D142615, D142965, D143335, D150215A, D150655, DA142885, DA150215, D142255, D142615A, D142965A, D143355, D150225, D150655A, DA142885A, DA150275, D142255A, D142625, D142975, D143355A, D150225A, D150685, DA142905, DA150275A, D142265, D142625A, D142975A, D143365, D150235, D150685A, DA142955, DA150285, D142265A, D142635, D142985, D143365A, D150235A, D150695, DA142965, DA150285A, D142275, D142655, D143005, D143375, D150275, D150695A, DA142965A, DA150295, D142275A, D142655A, D143005A, D143375A, D150275A, DA142185, DA142975, DA150335, D142305, D142665, D143015, D143385, D150285, DA142195, DA143005, DA150345, D142305A, D142665A, D143015A, D143385A, D150285A, DA142205, DA143025, DA150345A, D142315, D142675, D143025, D143395, D150295, DA142235, DA143025A, DA150365, D142315A, D142675A, D143025A, D143395A, D150295A, DA142235A, DA143035, DA150405, D142325, D142685, D143035, D143405, D150305, DA142245, DA143035A, DA150405A, D142325A, D142685A, D143035A, D143425, D150305A, DA142255, DA143085, DA150415, D142335, D142695, D143045, D143425A, D150335, DA142275, DA143095, DA150425, D142335A, D142695A, D143045A, D143435, D150335A, DA142305, DA143105, DA150435, D142345A, D142725, D143075, D143435A, D150345, DA142305A, DA143105A, DA150435A, D142375, D142725A, D143075A, D143445, D150345A, DA142315, DA143115, DA150475, D142375A, D142735, D143085, D143445A, D150355, DA142345, DA143155, DA150475A, D142385, D142735A, D143085A, D143455, D150355A, DA142345A, DA143155A, DA150495, D142385A, D142745, D143095, D143455A, D150375, DA142375, DA143165, DA150495A, D142395, D142745A, D143095A, D143465, D150405, DA142375A, DA143175, DA150515, D142395A, D142755, D143105, D143465A, D150405A, DA142385, DA143175A, DA150515A, D142405, D142755A, D143105A, D143495, D150415, DA142395, DA143185, DA150545, D142405A, D142765, D143115, D143495A, D150415A, DA142455, DA143215, DA150545A, D142415, D142765A, D143115A, D143505, D150425, DA142465, DA143235, DA150555, D142415A, D142795, D143155, D143505A, D150425A, DA142485, DA143235A, DA150555A, D142445, D142795A, D143155A, D143515, D150435, DA142515, DA143245, DA150635, D142445A, D142805, D143165, D143515A, D150435A, DA142515A, DA143295, DA150645, D142455, D142805A, D143165A, D150035, D150435A, DA142525, DA143295A, DA150645, D142455A, D142815, D143175, D150065, D150475, DA142535, DA143315, DA150645A, D142465, D142815A, D143175A, D150065A, D150475A, DA142535A, DA143315A, DA150655, D142465A, D142825, D143185, D150075, D150485, DA142585, DA143365, DA150685A, D142475, D142825A, D143185A, D150075A, D150485A, DA142585A, DA143365A, DA150685A, D142475A, D142835, D143215, D150085, D150495, DA142605, DA143385, DA150695, D142485, D142835A, D143215A, D150085A, D150495A, DA142615, DA143385A, DA150695A, D142485A, D142865, D143225, D150095, D150505, DA142615A, DA143395, D142515, D142875, D143225A, D150095A, D150505A, DA142625, DA143435, D142515A, D142875A, D143235, D150105, D150515, DA142655, DA143445, D142525, D142885, D143235A, D150125, D150515A, DA142665, DA143445A, D142525, D142885A, D143245, D150125A, D150545, DA142685, DA143455, D142525A, D142885A, D143245A, D150135, D150545A, DA142695, DA143465

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 9 of 14

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.

Z-1388-2015
Recall number
Z-1388-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420022-02; da Vinci S Camera Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142205, D142205A, D142275, D142275A, D142315, D142325, D142335, D142345, D142345A, D142375, D142375A, D142385, D142485, D142625, D142625A, D142655, D142685, D142695, D142695A, D142765, D142765A, D142835, D142835A, D142905, D142905A, D142965, D142975, D143015, D143035, D143035A, D143105, D143115, D143175, D143175A, D143185, D143245, D143255, D143255A, D143315, D143315A, D143385, D143385A, D143445, D143445A, D143515, D143515A, D150085, D150085A, D150095, D150155, D150155A, D150215, D150215A, D150295, D150295A, D150355, D150365, D150365A, D150425, D150435, D150435A, D150515, D150515A, D150565, D150575, D150575A, D150645, D150655, D150655A, DA142625, DA142835, DA143315, DA143385, DA150295, DA150515

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 10 of 14

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.

Z-1389-2015
Recall number
Z-1389-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420256-01; da Vinci S Disposable Accessory Kit, 3 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL 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

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 11 of 14

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.

Z-1390-2015
Recall number
Z-1390-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 12 of 14

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.

Z-1391-2015
Recall number
Z-1391-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420279-03; da Vinci Si Camera Arm Drape, 20 Pack. Lot Numbers: D142175, D142175A, D142185, D142185A, D142195, D142195A, D142205, D142205A, D142215, D142215A, D142235, D142235A, D142245, D142245A, D142255, D142255A, D142265, D142265A, D142305, D142305A, D142315, D142315A, D142325, D142325A, D142335, D142335A, D142345, D142345A, D142375, D142375A, D142385, D142385A, D142395, D142395A, D142405, D142405A, D142415, D142415A, D142445, D142445A, D142455, D142455A, D142465, D142465A, D142475, D142475A, D142485, D142515, D142515A, D142525, D142525A, D142535, D142535A, D142545, D142545A, D142555, D142555A, D142585, D142585A, D142595, D142595A, D142605, D142605A, D142615, D142615A, D142625, D142635, D142655, D142655A, D142665, D142665A, D142675, D142675A, D142685, D142685A, D142695 , D142695A, D142725, D142725A, D142735, D142735A, D142745, D142745A, D142755, D142755A, D142765, D142765A, D142795, D142795A, D142805, D142805A, D142815, D142815A, D142825, D142825A, D142835, D142865, D142865A, D142875, D142875A, D142885, D142885A, D142885A, D142895, D142905, D142905A, D142915, D142935, D142935A, D142945, D142945A, D142955, D142955A, D142965, D142965A, D142975, D142975A, D142985, D143005, D143005A, D143015, D143015A, D143025, D143025A, D143035, D143045, D143045A, D143075, D143075A, D143085, D143085A, D143095, D143095A, D143105, D143105A, D143115, D143115A, D143155, D143155A, D143165, D143165A, D143175, D143175A, D143185, D143185A, D143215, D143215A, D143225, D143225A, D143235, D143235A, D143245, D143245A, D143255, D143285, D143285A, D143295, D143295A, D143305, D143305A, D143315, D143315A, D143325, D143325A, D143335, D143355, D143355A, D143355A, D143365, D143365A, D143375, D143375A, D143385, D143395, D143395A, D143405, D143425, D143425A, D143435, D143435A, D143445, D143445A, D143455, D143455A, D143465, D143465A, D143495, D143495A, D143505, D143505A, D143515, D143515A, D150035, D150065, D150065A, D150075, D150075A, D150085, D150085A, D150125, D150125A, D150135, D150135A, D150145, D150145A , D150165, D150195, D150195A, D150205, D150205A, D150215, D150225, D150235, D150275, D150275A, D150285, D150285A, D150295, D150305, D150335, D150335A, D150345, D150345A, D150355, D150355A, D150405, D150405A, D150415, D150415A, D150425, D150425A, D150435, D150475, D150475A, D150485, D150485A, D150495, D150495A, D150505, D150505A, D150515, D150515A, D150545, D150545A, D150555, D150555A, D150565, D150565A, D150625, D150625A, D150635, D150635A , D150645, D150645A, D150655, D150685, D150685A, D150695, D150695A, DA142185, DA142185A, DA142235, DA142235A, DA142245, DA142255, DA142305, DA142305A, DA142455, DA142515, DA142515A, DA142525, DA142535, DA142545, DA142585, DA142585A, DA142605, DA142615, DA142655, DA142745, DA142745A, DA142755, DA142795, DA142795A, DA142825, DA142825A, DA142865, DA142875, DA142885, DA142885A, DA142945 , DA142965, DA142975, DA143005, DA143025, DA143075, DA143095, DA143105, DA143155, DA143185, DA143215, DA143235, DA143245, DA143285, DA143295, DA143365, DA143395, DA143435, DA143455, DA143465, DA143465A, DA143495, DA150075, DA150125, DA150125A, DA150135, DA150145, DA150195, DA150205, DA150205A, DA150275, DA150275A, DA150285, DA150285A, DA150335, DA150335A, DA150345, DA150405, DA150405A, DA150415, DA150415A, DA150475, DA150495, DA150545, DA150545A, DA150555, DA150565, DA150625, DA150635, DA150645, DA150685, DA150695, DA150695A

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 13 of 14

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.

Z-1392-2015
Recall number
Z-1392-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420290-03; da Vinci Si Disposable Accessory Kit, 3 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142175, D142175A, D142185, D142185A, D142235, D142235A, D142245, D142245A, D142255, D142305, D142305A, D142315, D142315A, D142345, D142375, D142375A, D142385, D142385A, D142395, D142455, D142465, D142465A, D142475, D142475A, D142485, D142515, D142515A, D142525, D142525A, D142535, D142535A, D142605, D142605A, D142615, D142615A, D142625, D142635, D142655, D142655A, D142665, D142665A, D142725, D142725A, D142735, D142735A, D142745, D142755, D142755A, D142795, D142795A, D142825, D142825A, D142835, D142885, D142885A, D142885A, D142895, D142905, D142945, D142955, D142955A, D142965, D142965A, D143005, D143015, D143015A, D143025, D143025A, D143035, D143045, D143045A, D143095, D143095A, D143105, D143105A, D143155, D143155A, D143165, D143165A, D143175, D143175A, D143185, D143185A, D143215, D143215A, D143225, D143225A, D143235, D143235A, D143295, D143295A, D143305, D143305A, D143315, D143325, D143325A, D143365, D143375, D143375A, D143385, D143395, D143395A, D143435, D143445, D143445A, D143455, D143455A, D143465, D143465A, D150075, D150085, D150125, D150125A, D150135, D150165, D150195, D150195A, D150205, D150205A, D150275, D150275A, D150285, D150305, D150345, D150345A, D150355, D150355A, D150415, D150415A, D150425, D150425A, D150435, D150475, D150475A, D150485, D150485A, D150495, D150545, D150545A, D150555, D150555A, D150635, D150635A, D150645, D150645A, D150685, D150685A, D150695, D150695A, DA142235, DA142305, DA142515, DA142615, DA142795, DA142885, DA142885, DA143025, DA150125, DA150275, DA150475, DA150545, DA150645, DA150685

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

device · product 14 of 14

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.

Z-1393-2015
Recall number
Z-1393-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
442,475 total for all drape models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product number 420291-03; da Vinci Si Disposable Accessory Kit, 4 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142185, D142195, D142195A, D142205, D142215, D142255, D142255A, D142265, D142265A, D142325, D142325A, D142335, D142335A, D142345, D142395, D142405, D142405A, D142415, D142415A, D142445, D142445A, D142455, D142455A, D142535, D142545, D142545A, D142555, D142555A, D142585, D142585A, D142595, D142595A, D142675, D142675A, D142685, D142685A, D142695, D142695A, D142745, D142745A, D142755, D142765, D142805, D142805A, D142815, D142815A, D142825, D142865, D142865, D142865A, D142875, D142875A, D142885, D142915, D142935, D142935A, D142945, D142975, D142975A, D142985, D143005, D143075, D143075A, D143085, D143085A, D143095, D143115, D143115A, D143155, D143235, D143245, D143255, D143285, D143285A, D143295, D143335, D143355, D143355A, D143365, D143365A, D143405, D143425, D143425A, D143435, D143435A, D143465, D143495, D143495A, D143505, D143505A, D143515, D150065, D150065A, D150075, D150075A, D150135, D150135A, D150145, D150145A, D150205, D150215, D150285, D150285A, D150295, D150335, D150335A, D150345, D150405, D150405A, D150415, D150495, D150495A, D150505, D150505A, D150515, D150515A, D150555, D150565, D150565A, D150625, D150625A, D150635, D150695, DA142585, DA150335, DA150405

Distribution pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.