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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95938

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

37 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 37

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

Z-0847-2025
Recall number
Z-0847-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
355,547

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470179 Part Number: 470179-19 UDI-DI code: 00886874112298 Batch Number: K10221127 K10221218 K10221228 K10230103 K10230108 K10230112 K10230122 K10230129 K10230205 K10230212 K10230219 K10230226 K10230302 K10230310 K10230315 K10230316 K10230323 K10230330 K10230403 K10230405 K10230412 K10230413 K10230420 K10230504 K10230509 K10230511 K10230516 K10230518 K10230525 K10230531 K10230601 K10230602 K10230608 K10230615 K10230620 K10230622 K10230629 K10230630 K10230706 K10230713 K10230720 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230914 K10230921 K10230928 K10231005 K10231006 K10231012 K10231019 K10231026 K10231102 K10231109 K10231123 K10231130 K10231207 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240125 K10240201 K10240208 K10240215 K10240222 K10240229 K10240301 K10240307 K10240314 K10240315 K10240321 K10240327 K10240410 K10240411 K10240418 K10240425 K10240426 K10240502 K10240515 K10240516 K10240523 K10240530 K10240605 K10240606 K10240613 K10240620 K10240627 K10240702 K10240713 K11221127 K11221128 K11221218 K11230103 K11230108 K11230112 K11230122 K11230129 K11230205 K11230212 K11230219 K11230226 K11230302 K11230310 K11230315 K11230316 K11230323 K11230330 K11230403 K11230405 K11230412 K11230413 K11230420 K11230504 K11230509 K11230511 K11230518 K11230525 K11230601 K11230608 K11230615 K11230622 K11230629 K11230630 K11230706 K11230713 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11230928 K11231005 K11231006 K11231012 K11231019 K11231026 K11231102 K11231109 K11231123 K11231130 K11231207 K11231214 K11231218 K11240104 K11240111 K11240118 K11240125 K11240201 K11240208 K11240215 K11240222 K11240229 K11240307 K11240314 K11240321 K11240327 K11240404 K11240411 K11240418 K11240425 K11240502 K11240509 K11240515 K11240516 K11240523 K11240530 K11240605 K11240606 K11240613 K11240620 K11240627 K11240702 K12221128 K12221212 K12221218 K12230103 K12230108 K12230112 K12230122 K12230129 K12230205 K12230212 K12230219 K12230226 K12230302 K12230310 K12230316 K12230323 K12230330 K12230405 K12230412 K12230413 K12230420 K12230504 K12230509 K12230511 K12230518 K12230525 K12230601 K12230608 K12230615 K12230622 K12230629 K12230706 K12230713 K12230727 K12230803 K12230810 K12230817 K12230824 K12230831 K12230907 K12230914 K12230921 K12230928 K12231005 K12231006 K12231012 K12231019 K12231026 K12231109 K12231123 K12231130 K12231207 K12231214 K12231218 K12240104 K12240111 K12240118 K12240125 K12240201 K12240208 K12240215 K12240222 K12240229 K12240307 K12240321 K12240327 K12240404 K12240411 K12240418 K12240425 K12240502 K12240509 K12240516 K12240523 K12240530 K12240606 K12240613 K12240620 K12240627 K12240702 K13221128 K13230103 K13230108 K13230112 K13230122 K13230129 K13230205 K13230212 K13230219 K13230226 K13230302 K13230316 K13230323 K13230330 K13230405 K13230413 K13230420 K13230504 K13230511 K13230518 K13230525 K13230601 K13230608 K13230615 K13230622 K13230706 K13230713 K13230727 K13230803 K13230810 K13230817 K13230824 K13230831 K13230907 K13230914 K13230921 K13230928 K13231005 K13231012 K13231019 K13231026 K13231109 K13231123 K13231130 K13231207 K13231214 K13231218 K13240104 K13240118 K13240125 K13240201 K13240208 K13240215 K13240222 K13240229 K13240307 K13240321 K13240327 K13240404 K13240411 K13240418 K13240425 K13240502 K13240509 K13240516 K13240523 K13240530 K13240606 K13240613 K13240627 K13240702 K14221128 K14221212 K14221218 K14230103 K14230108 K14230112 K14230122 K14230129 K14230212 K14230226 K14230323 K14230413 K14230420 K14230504 K14230511 K14230518 K14230525 K14230601 K14230608 K14230615 K14230622 K14230706 K14230727 K14230803 K14230810 K14230817 K14230824 K14230831 K14230914 K14230921 K14230928 K14231005 K14231012 K14231026 K14231109 K14231123 K14231130 K14231207 K14231214 K14231218 K14240104 K14240111 K14240118 K14240125 K14240201 K14240208 K14240215 K14240222 K14240229 K14240307 K14240314 K14240321 K14240327 K14240404 K14240411 K14240425 K14240502 K14240509 K14240516 K14240523 K14240530 K14240606 K14240613 K14240620 K14240627 K14240702 K15221128 K15221212 K15221218 K15230108 K15230112 K15230122 K15230129 K15230212 K15230226 K15230323 K15230405 K15230413 K15230420 K15230427 K15230518 K15230525 K15230727 K15230810 K15230824 K15230921 K15231005 K15231012 K15231116 K15231123 K15231207 K15231214 K15231218 K15240104 K15240118 K15240125 K15240208 K15240215 K15240222 K15240229 K15240307 K15240314 K15240404 K15240411 K15240502 K15240509 K15240516 K15240523 K15240530 K15240606 K15240613 K15240620 K15240627 K15240702 K16221212 K16221218 K16230122 K16230212 K16230427 K16230525 K16230810 K16231005 K16231012 K16231116 K16231123 K16231207 K16231214 K16240104 K16240118 K16240208 K16240215 K16240222 K16240229 K16240307 K16240404 K16240411 K16240502 K16240509 K16240516 K16240523 K16240530 K16240606 K16240613 K16240620 K16240627 K16240702 K17221218 K17230122 K17230427 K17231116 K17240104 K17240229 K17240307 K17240411 K17240502 K17240523 K17240613 K18221212 K18221218 K18230427 K18231116 K18240229 K18240307 K18240411 K18240502 K19221212 K19221218 K19230427 K19231116 K19240229 K19240307 Part Number: 470179-21 UDI-DI code: 00886874112298 Batch Number: K10240509 K10240607 K10240718 K10240719 K10240725 K10240801 K10240805 K10240808 K10240822 K10240826 K10240829 K11240711 K11240718 K11240725 K11240801 K11240808 K11240815 K12240711 K12240718 K12240725 K12240801 K12240815 K13240711 K13240718 K13240725 K13240801 K14240711 K14240718 K14240725 K14240801 K15240711 K15240718 K15240801 K16240711 K16240808 K16240829 K17240808 Part Number: 470179-22 UDI-DI code: 00886874112298 Batch Number: K10230914 K10240229 K11230803

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 2 of 37

8MM, POTTS SCISSORS, IS4000 REF 470001

Z-0848-2025
Recall number
Z-0848-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
3,625

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470001 Part Number: 470001-09 UDI-DI code: 00886874112120 Batch Numbers: K10230308 K11230308 K10230517

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 3 of 37

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

Z-0849-2025
Recall number
Z-0849-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
10,603

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470006 Part Number: 470006-12 UDI-DI code: 00886874112151 Batch Numbers: K10230120 K10230118 K12230119 K11230118 K10230217 Part Number: 470006-13 UDI-DI code: 00886874112151 Batch Numbers: K10230623 K10240506 K10240815

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 4 of 37

8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007

Z-0850-2025
Recall number
Z-0850-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
4,259

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470007 Part Number: 470007-05 UDI-DI code: 00886874112168 Batch Numbers: K11221228 K10221228 K12230103 K10230122 K10230131 K10230302 K10230525 K10231012 K10231016 K13231027 K10231219 K11231221 K11240104 K10240117 K10240627

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 5 of 37

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

Z-0851-2025
Recall number
Z-0851-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
1,111

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470033 Part Number: 470033-09 UDI-DI code: 00886874112229 Batch Numbers: K10230219 K10230316 K10230511 K10230615 K10230706 K10230713 K10230824 K10230928 K10231005 K10231109 K10231218 K10240104 K10240229 K10240418 K10240613 Part Number: 470033-11 UDI-DI code: 00886874112229 Batch Number: K10230914

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 6 of 37

8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036

Z-0852-2025
Recall number
Z-0852-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
1,739

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470036 Part Number: 470036-04 UDI-DI code: 00886874112236 Batch Numbers: K10221128 K10221218 K10230219 K10230226 K10230323 K10230518 K10230525 K10230601 K10230608 K10230615 K10230713 K10230824 K10230907 K10231005 K10231019 K10231214 K10240208 K10240222 K10240411 K10240418 K10240711 K10240722 K10240801 Part Number: 470036-06 UDI-DI code: 00886874112229 Batch Number: K10230803

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 7 of 37

8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049

Z-0853-2025
Recall number
Z-0853-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
8,578

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470049 Part Number: 470049-08 UDI-DI code: 00886874112250 Batch Numbers: K10221218 K10221220 K10230219 K10230226 K10230302 K10230310 K10230316 K10230323 K10230330 K10230405 K10230413 K10230420 K10230601 K10230608 K10230615 K10230706 K10230720 K10230921 K10230928 K10231005 K10231012 K10231109 K10231130 K10240327 K10240404 K10240418 K10240425 K10240502 K10240515 K11230413 K11230420 K11230720 K11231130 K11240502 K11240515

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 8 of 37

8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093

Z-0854-2025
Recall number
Z-0854-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
2,852

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470093 Part Number: 470093-11 UDI-DI code: 00886874112267 Batch Numbers: K10221211 K10230302 K10230413 K10230420 K10230615 K10231025 K10231027 K10231123 K10240222 K10240327 K10240404

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 9 of 37

8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171

Z-0855-2025
Recall number
Z-0855-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
178

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470171 Part Number: 470171-15 UDI-DI code: 00886874112274 Batch Numbers: K10230801 K10240425 K10240613 K10240702 K11231116

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 10 of 37

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172

Z-0856-2025
Recall number
Z-0856-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
7,132

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470172 Part Number: 470172-17 UDI-DI code: 00886874112281 Batch Numbers: K10221204 K10230219 K10230226 K10230302 K10230310 K10230427 K10230518 K10230525 K10230601 K10230608 K10230615 K10230622 K10230629 K10230913 K10231019 K10231123 K10240222 K10240327 K10240404 K10240418 K10240425 K10240502 K10240711 K11231019 K11231116 K11240502 K11240711

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 11 of 37

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

Z-0857-2025
Recall number
Z-0857-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
373

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470181 Part Number: 470181-09 UDI-DI code: 00886874112304 Batch Numbers: K10230601 K10230608 K10230824 K10230928 K10231012 K10231027 K10240118 K10240222 K10240516 K10240711 K10240725 K10240801

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 12 of 37

8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194

Z-0858-2025
Recall number
Z-0858-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
38,438

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470194 Part Number: 470194-06 UDI-DI code: 00886874112342 Batch Numbers: K10221113 K10221128 K10221204 K10221212 K10221218 K10230112 K10230205 K10230212 K10230217 K10230824 K10240418 K10240502 K10240523 K10240718 K10240801 K11221212 K11230112 K11230217 K11240418 K12230112 K12230217 K16240702 U10230217 Model Number: 470194 Part Number: 470194-08 UDI-DI code: 00886874112342 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230405 K10230420 K10230511 K10230525 K10230601 K10230608 K10230615 K10230622 K10230706 K10230713 K10230720 K10230727 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231214 K10240104 K10240111 K10240118 K10240125 K10240202 K10240208 K10240215 K10240314 K10240327 K10240404 K10240425 K10240509 K10240515 K10240523 K10240606 K10240613 K10240620 K10240627 K10240702 K10240822 K11230302 K11230310 K11230323 K11230720 K11230727 K11230914 K11231012 K11231027 K11231109 K11240118 K11240125 K11240314 K11240404 K11240509 K11240620 K11240822 K12230302 K12230914 K12240404 K12240509 K12240620 U10230517

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 13 of 37

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205

Z-0859-2025
Recall number
Z-0859-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
12,340

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470205 Part Number: 470205-17 UDI-DI code: 00886874112359 Batch Numbers: K10221204 K10221218 K10230103 K10230219 K10230226 K10230310 K10230316 K10230323 K10230330 K10230405 K10230413 K10230420 K10230504 K10230526 K10230601 K10230615 K10230622 K10230629 K10230817 K10230824 K10230913 K10230921 K10230928 K10231019 K10231027 K10231102 K10231109 K10240129 K10240201 K10240222 K10240229 K10240307 K10240314 K10240321 K10240327 K10240404 K10240411 K10240502 K10240516 K10240523 K10240801 K11230316 K11230413 K11231116 K11240201 K11240327 K15240516

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 14 of 37

8MM,TENACULUM FORCEPS,IS4000¿ REF 470207

Z-0860-2025
Recall number
Z-0860-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
11,162

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470207 Part Number: 470207-10 UDI-DI code: 00886874112366 Batch Numbers: K10221218 K10230108 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230810 K10230928 K10231005 K10231109 K10231123 K10231130 K10240104 K10240111 K10240119 K10240208 K10240215 K10240222 K10240314 K10240321 K10240411 K10240417 K10240502 K10240509 K10240613 K10240620 K10240815 K10240822 K11230108 K11230817 K11230928 K11231116 K11231123 K11240119 K12231123

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 15 of 37

8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230

Z-0861-2025
Recall number
Z-0861-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
29,559

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K10230212 K10230226 K10230302 K10230310 K10230315 K10230323 K10230405 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230602 K10230608 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230921 K10231005 K10231012 K10231019 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240119 K10240125 K10240208 K10240215 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240418 K10240516 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240718 K10240808 K10240822 K11230103 K11230108 K11230212 K11230302 K11230315 K11230511 K11230518 K11230615 K11230622 K11230727 K11230817 K11230921 K11231005 K11231123 K11231214 K11240119 K11240125 K11240229 K11240404 K11240523 K11240620 K12230103 K12230108 K12230315 K12231116 K12240125 K12240404 K13230108 Model Number: 470230 Part Number: 470230-14 UDI-DI code: 00886874112380 Batch Numbers: K10230914

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 16 of 37

8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246

Z-0862-2025
Recall number
Z-0862-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
738

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470246 Part Number: 470246-09 UDI-DI code: 00886874112397 Batch Numbers: K10230219 K10230226 K10230525 K10230601 K10230608 K10230615 K10231218 K10240104 K10240111 K10240411 K10240613 K10240620 K10240711 K10240725

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 17 of 37

8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249

Z-0863-2025
Recall number
Z-0863-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
783

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470249 Part Number: 470249-09 UDI-DI code: 00886874112403 Batch Numbers: K10230226 K10230316 K10230323 K10230331 K10230518 K10230824 K10230831 K10231130 K10231214 K10240118 K10240208 K10240222 K10240327 K10240509 K10240711 K10240725 K10240801 K11231116

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 18 of 37

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296

Z-0864-2025
Recall number
Z-0864-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
784

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470296 Part Number: 470296-05 UDI-DI code: 00886874112410 Batch Numbers: K10230217 Model Number: 470296 Part Number: 470296-08 UDI-DI code: 00886874112410 Batch Numbers: K10230302 K10230413 K10230420 K10230427 K10230824 K10231123 K10240229 K10240425 K10240627 K10240718 K16240613

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 19 of 37

8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309

Z-0865-2025
Recall number
Z-0865-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470309 Part Number: 470309-15 UDI-DI code: 00886874112434 Batch Numbers: K10230217 Model Number: 470309 Part Number: 470309-17 UDI-DI code: 00886874112410 Batch Numbers: K10230302

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 20 of 37

8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318

Z-0866-2025
Recall number
Z-0866-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
9,303

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470318 Part Number: 470318-10 UDI-DI code: 00886874112441 Batch Numbers: K10230212 K10230219 K10230226 K10230420 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230817 K10230831 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231130 K10231207 K10240104 K10240116 K10240125 K10240222 K10240327 K10240404 K10240516 K10240523 K10240606 K10240711 K10240725 K10240822 K10240829 K11230608

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 21 of 37

8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327

Z-0867-2025
Recall number
Z-0867-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
30,316

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470327 Part Number: 470327-12 UDI-DI code: 00886874112465 Batch Numbers: K10221120 K10221212 K10230103 K10230108 K10230205 K10230212 K10230219 K10230226 K10230302 K10230330 K10230405 K10230413 K10230420 K10230427 K10230504 K10230509 K10230511 K10230518 K10230601 K10230608 K10230622 K10230629 K10230706 K10230713 K10230720 K10230727 K10230803 K10230805 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240111 K10240118 K10240201 K10240208 K10240215 K10240222 K10240229 K10240307 K10240314 K10240321 K10240327 K10240404 K10240418 K10240425 K10240509 K10240523 K10240606 K10240613 K10240711 K10240718 K10240725 K10240801 K10240808 K10240822 K11230103 K11230108 K11230212 K11230226 K11230504 K11230518 K11230525 K11230601 K11230608 K11230622 K11230629 K11230706 K11230720 K11230727 K11230810 K11230817 K11230928 K11231012 K11231027 K11231207 K11231214 K11231218 K11240208 K11240215 K11240222 K11240314 K11240404 K11240418 K11240509 K11240523 K11240613 K11240718 K12230226 K12230504 K12230622 K12230810 K12231012 K12231116 K12240314 K12240411 K12240509 K12240523 K12240718 K13221204 K13230108 K13230622 K13240411 K13240523 K13240718 K14230108 K14240411 Model Number: 470327 Part Number: 470327-14 UDI-DI code: 00886874112465 Batch Numbers: K10230914 K10240208

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 22 of 37

8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344

Z-0868-2025
Recall number
Z-0868-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
141

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470344 Part Number: 470344-17 UDI-DI code: 00886874112489 Batch Numbers: K10230405 K10230413 K10230420 K10230504

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 23 of 37

8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347

Z-0869-2025
Recall number
Z-0869-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
72,646

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470347 Part Number: 470347-11 UDI-DI code: 00886874112496 Batch Numbers: K10230122 K10230129 K10230227 K10230302 K10230313 K10230316 K10230323 K10230330 K10230405 K10230413 K10230420 K10230427 K10230428 K10230504 K10230511 K10230516 K10230518 K10230525 K10230601 K10230602 K10230608 K10230615 K10230622 K10230629 K10230706 K10230710 K10230713 K10230719 K10230720 K10230727 K10230801 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230913 K10230914 K10230921 K10230928 K10231005 K10231019 K10231027 K10231102 K10231123 K10231130 K10231218 K10240104 K10240111 K10240116 K10240118 K10240124 K10240125 K10240208 K10240215 K10240218 K10240222 K10240229 K10240303 K10240307 K10240315 K10240322 K10240326 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240606 K10240618 K10240718 K10240725 K10240801 K10240805 K10240808 K10240815 K11230122 K11230313 K11230316 K11230323 K11230330 K11230405 K11230413 K11230420 K11230427 K11230504 K11230511 K11230518 K11230525 K11230601 K11230602 K11230608 K11230615 K11230622 K11230629 K11230706 K11230710 K11230713 K11230719 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11230928 K11231005 K11231102 K11231130 K11231218 K11240104 K11240111 K11240118 K11240125 K11240229 K11240307 K11240315 K11240326 K11240418 K11240425 K11240516 K11240523 K11240530 K11240606 K11240725 K11240801 K12230122 K12230313 K12230323 K12230330 K12230405 K12230413 K12230420 K12230427 K12230504 K12230511 K12230518 K12230525 K12230601 K12230608 K12230615 K12230622 K12230629 K12230706 K12230713 K12230719 K12230720 K12230727 K12230803 K12230810 K12230817 K12230824 K12230831 K12230907 K12230914 K12230921 K12230928 K12231005 K12231218 K12240111 K12240125 K12240229 K12240307 K12240418 K12240516 K12240530 K12240801 K12240808 K13230122 K13230405 K13230413 K13230420 K13230427 K13230504 K13230518 K13230525 K13230601 K13230608 K13230615 K13230622 K13230629 K13230706 K13230713 K13230720 K13230727 K13230803 K13230810 K13230817 K13230824 K13230831 K13230907 K13230914 K13230921 K13230928 K13231218 K13240229 K13240418 K13240530 K13240801 K14230420 K14230511 K14230518 K14230525 K14230601 K14230608 K14230615 K14230622 K14230629 K14230706 K14230713 K14230720 K14230727 K14230803 K14230824 K14230907 K14230921 K14231218 K14240418 K14240801 K15230629 K15230720 K15230727 K15230803 K15230824 K16230720 K16230727 K16230803 K17230720 K17230727 K17230803 K18230727 Model Number: 470347 Part Number: 470347-12 UDI-DI code: 00886874112496 Batch Numbers: K10230112 K11221120 K11221212 K12221120 Model Number: 470347 Part Number: 470347-14 UDI-DI code: 00886874112496 Batch Numbers: K10230914 K10240327 K10240404 K10240425 K10240502 Model Number: 470347 Part Number: 470347-16 UDI-DI code: 00886874112496 Batch Numbers: K10240725

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 24 of 37

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

Z-0870-2025
Recall number
Z-0870-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
5,576

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470401 Part Number: 470401-07 UDI-DI code: 00886874112670 Batch Numbers: K10230129 K10230205 K10230212 K10230226 K10230323 K10230405 K10230413 K10230420 K10230504 K10230608 K10230630 K10230706 K10230713 K10230803 K10230810 K10230817 K10230928 K10231005 K10231019 K10231027 K10231102 K10230112 K10240125 K10240208 K10240222 K10240327 K10240411 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240725 K11240112 Model Number: 470401 Part Number: 470401-08 UDI-DI code: 00886874112670 Batch Numbers: K10230914 K10231012 K10240327 K10240509 K10240523 K10240530

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 25 of 37

8MM,FORCE BIPOLAR,IS4000 REF 470405

Z-0871-2025
Recall number
Z-0871-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 470405 Part Number: 470405-06 UDI-DI code: 00886874115930 Batch Number: K10230713

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 26 of 37

8MM,LONG TIP FORCEPS,IS4000 REF 471048

Z-0872-2025
Recall number
Z-0872-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
1,562

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471048 Part Number: 471048-09 UDI-DI code: 00886874115930 Batch Numbers: K10230330 K10230420 K10230515 K10230706 K10230720 K10230810 K10230907 K10230921 K10231005 K10231019 K10231102 K10231123 K10231207 K10240229 K10240314 K10240321 K10240411 K10240418 K10240509 K10240516 K10240718 K10240725 K10240822

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 27 of 37

8MM,CADIERE FORCEPS,IS4000 REF 471049

Z-0873-2025
Recall number
Z-0873-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
56,580

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471049 Part Number: 471049-08 UDI-DI code: 00886874119778 Batch Numbers: K10221218 K10230112 K10230122 K10230219 K10230226 K10230302 K10230323 K10230405 K10230413 K10230420 K10230427 K10230515 K10230518 K10230525 K10230608 K10230615 K10230622 K10230706 K10230713 K10230714 K10230720 K10230727 K10230803 K10230817 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231130 K10231205 K10231207 K10231214 K10231218 K10240104 K10240110 K10240111 K10240116 K10240118 K10240208 K10240215 K10240222 K10240308 K10240321 K10240327 K10240404 K10240411 K10240418 K10240509 K10240516 K10240530 K10240606 K10240613 K10240614 K10240620 K10240621 K10240711 K10240718 K10240725 K10240903 K11230112 K11230226 K11230405 K11230515 K11230518 K11230525 K11230608 K11230615 K11230622 K11230706 K11230713 K11230714 K11230720 K11230727 K11230803 K11230817 K11230921 K11230928 K11231012 K11231027 K11231109 K11231130 K11231207 K11231214 K11240104 K11240118 K11240208 K11240215 K11240321 K11240327 K11240404 K11240411 K11240418 K11240509 K11240516 K11240530 K11240606 K11240613 K11240620 K11240621 K11240718 K11240725 K12230112 K12230226 K12230515 K12230602 K12230608 K12230615 K12230706 K12230720 K12230727 K12230928 K12231012 K12231130 K12231214 K12240118 K12240215 K12240321 K12240418 K12240718 K13230112 K13230928 K13231012 K13231130 K13231214 K14230112 K14231130 K15230112 K16240508 K17240508 K17240830 K18240830

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 28 of 37

8MM,PROGRASP FORCEPS,IS4000 REF 471093

Z-0874-2025
Recall number
Z-0874-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
99,249

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471093 Part Number: 471093-11 UDI-DI code: 00886874119785 Batch Numbers: K10221118 K10221124 K10221128 K10221204 K10221212 K10221218 K10230103 K10230108 K10230122 K10230125 K10230129 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230324 K10230405 K10230413 K10230420 K10230427 K10230515 K10230518 K10230525 K10230531 K10230601 K10230608 K10230615 K10230622 K10230629 K10230706 K10230713 K10230714 K10230720 K10230727 K10230802 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230914 K10230921 K10231012 K10231027 K10231102 K10231109 K10231123 K10231201 K10231208 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240124 K10240125 K10240201 K10240208 K10240215 K10240222 K10240229 K10240307 K10240321 K10240327 K10240404 K10240418 K10240425 K10240502 K10240509 K10240516 K10240523 K10240530 K10240606 K10240618 K10240808 K11221118 K11221204 K11221212 K11230103 K11230108 K11230122 K11230125 K11230129 K11230205 K11230212 K11230226 K11230302 K11230310 K11230316 K11230323 K11230324 K11230405 K11230420 K11230515 K11230518 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11231012 K11231027 K11231102 K11231109 K11231123 K11231201 K11231208 K11231213 K11231214 K11231218 K11240104 K11240111 K11240118 K11240125 K11240201 K11240208 K11240222 K11240229 K11240307 K11240321 K11240327 K11240404 K11240418 K11240425 K11240502 K11240509 K11240516 K11240523 K11240530 K11240606 K11240618 K12221118 K12221128 K12221204 K12221212 K12230108 K12230125 K12230226 K12230302 K12230310 K12230324 K12230405 K12230420 K12230515 K12230518 K12230601 K12230608 K12230615 K12230622 K12230706 K12230720 K12230727 K12230803 K12230810 K12230817 K12230824 K12230914 K12230921 K12231012 K12231027 K12231102 K12231116 K12231123 K12231201 K12231208 K12240104 K12240111 K12240118 K12240125 K12240201 K12240208 K12240222 K12240229 K12240321 K12240404 K12240418 K12240502 K12240509 K12240516 K12240523 K12240530 K12240606 K13221118 K13221128 K13230108 K13230226 K13230310 K13230515 K13230518 K13230615 K13230706 K13230727 K13230810 K13230824 K13230914 K13230921 K13231102 K13231116 K13231208 K13240104 K13240118 K13240201 K13240418 K13240509 K13240516 K13240530 K14221118 K14230226 K14230515 K14230824 K14230921 K14231208 K14240118 K14240530 K15231208 K16240508 K10221118 K10221124 K10221128 K10221204 K10221212 K10221218 K10230103 K10230108 K10230122 K10230125 K10230129 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230324 K10230405 K10230413 K10230420 K10230427 K10230515 K10230518 K10230525 K10230531 K10230601 K10230608 K10230615 K10230622 K10230629 K10230706 K10230713 K10230714 K10230720 K10230727 K10230802 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230914 K10230921 K10231012 K10231027 K10231102 K10231109 K10231123 K10231201 K10231208 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240124 K10240125 K10240201 K10240208 K10240215 K10240222 K10240229 K10240307 K10240321 K10240327 K10240404 K10240418 K10240425 K10240502 K10240509 K10240516 K10240523 K10240530 K10240606 K10240618 K10240808 K11221118 K11221204 K11221212 K11230103 K11230108 K11230122 K11230125 K11230129 K11230205 K11230212 K11230226 K11230302 K11230310 K11230316 K11230323 K11230324 K11230405 K11230420 K11230515 K11230518 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11231012 K11231027 K11231102 K11231109 K11231123 K11231201 K11231208 K11231213 K11231214 K11231218 K11240104 K11240111 K11240118 K11240125 K11240201 K11240208 K11240222 K11240229 K11240307 K11240321 K11240327 K11240404 K11240418 K11240425 K11240502 K11240509 K11240516 K11240523 K11240530 K11240606 K11240618 K12221118 K12221128 K12221204 K12221212 K12230108 K12230125 K12230226 K12230302 K12230310 K12230324 K12230405 K12230420 K12230515 K12230518 K12230601 K12230608 K12230615 K12230622 K12230706 K12230720 K12230727 K12230803 K12230810 K12230817 K12230824 K12230914 K12230921 K12231012 K12231027 K12231102 K12231116 K12231123 K12231201 K12231208 K12240104 K12240111 K12240118 K12240125 K12240201 K12240208 K12240222 K12240229 K12240321 K12240404 K12240418 K12240502 K12240509 K12240516 K12240523 K12240530 K12240606 K13221118 K13221128 K13230108 K13230226 K13230310 K13230515 K13230518 K13230615 K13230706 K13230727 K13230810 K13230824 K13230914 K13230921 K13231102 K13231116 K13231208 K13240104 K13240118 K13240201 K13240418 K13240509 K13240516 K13240530 K14221118 K14230226 K14230515 K14230824 K14230921 K14231208 K14240118 K14240530 K15231208 K16240508

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 29 of 37

8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171

Z-0875-2025
Recall number
Z-0875-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
1,036

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471171 Part Number: 471171-15 UDI-DI code: 00886874121474 Batch Numbers: K10230405 K10230413 K10230601 K10230615 K10230713 K10230817 K10230907 K10230913 K10231103 K10231123 K10231130 K10231207 K10231214 K10231221 K10240104 K10240118 K10240208 K10240222 K10240327 K10240411 K10240502 K10240516 K10240702 K10240711 K16240508 K16240530

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 30 of 37

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172

Z-0876-2025
Recall number
Z-0876-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
68,458

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471172 Part Number: 471172-16 UDI-DI code: 00886874119792 Batch Numbers: K10230831 K11230831 K12230831 K16240508 K17240508 K18240508 Model Number: 471172 Part Number: 471172-17 UDI-DI code: 00886874119792 Batch Numbers: K10221030 K10221122 K10221128 K10221212 K10221218 K10230103 K10230122 K10230129 K10230201 K10230205 K10230212 K10230219 K10230226 K10230302 K10230427 K10230504 K10230510 K10230515 K10230518 K10230526 K10230601 K10230608 K10230615 K10230622 K10230629 K10230706 K10230713 K10230714 K10230720 K10230727 K10230803 K10230810 K10230817 K10230824 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231201 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240120 K10240125 K10240201 K10240208 K10240215 K10240229 K10240314 K10240327 K10240404 K10240410 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240603 K10240606 K10240613 K10240618 K10240702 K10240703 K10240708 K11221030 K11221212 K11221218 K11230122 K11230205 K11230302 K11230310 K11230504 K11230515 K11230518 K11230526 K11230601 K11230608 K11230615 K11230622 K11230629 K11230706 K11230713 K11230727 K11230803 K11230810 K11230817 K11230824 K11230907 K11230914 K11230921 K11230928 K11231005 K11231019 K11231102 K11231109 K11231123 K11231201 K11231214 K11240104 K11240111 K11240118 K11240125 K11240201 K11240215 K11240229 K11240404 K11240418 K11240502 K11240509 K11240523 K11240530 K11240606 K11240613 K11240618 K11240702 K11240711 K12221218 K12230122 K12230205 K12230515 K12230518 K12230601 K12230608 K12230615 K12230622 K12230629 K12230727 K12230803 K12230810 K12231005 K12231019 K12231214 K12240111 K12240201 K12240404 K12240502 K12240509 K12240523 K12240530 K12240711 K13230122 K13230515 K13230518 K13230601 K13230622 K13230810 K13231005 K13231019 K13240404 K13240509 K13240711 K14230122 K14230515 K14230518 K14230525 K15230122 K15230515 K15230525

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 31 of 37

8MM,COBRA GRASPER,IS4000 REF 471190

Z-0877-2025
Recall number
Z-0877-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
2,472

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471190 Part Number: 471190-04 UDI-DI code: 00886874121481 Batch Numbers: K10230226 K10230405 K10230413 K10230420 K10231005 K10231019 K10231130 K10240104 K10240111 K10240118 K10240327 K10240418 K10240502 K10240606 K10240725

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 32 of 37

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205

Z-0878-2025
Recall number
Z-0878-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
147,006

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471205 Part Number: 471205-17 UDI-DI code: 00886874119808 Batch Numbers: K10221106 K10221128 K10221204 K10221212 K10221218 K10230103 K10230108 K10230111 K10230112 K10230122 K10230129 K10230205 K10230208 K10230212 K10230219 K10230226 K10230302 K10230310 K10230316 K10230323 K10230405 K10230413 K10230420 K10230427 K10230515 K10230518 K10230526 K10230601 K10230608 K10230612 K10230615 K10230622 K10230629 K10230706 K10230713 K10230720 K10230725 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231109 K10231123 K10231201 K10231205 K10231207 K10231213 K10231220 K10240130 K10240131 K10240201 K10240202 K10240208 K10240215 K10240216 K10240222 K10240229 K10240307 K10240314 K10240321 K10240325 K10240327 K10240404 K10240408 K10240411 K10240418 K10240425 K10240502 K10240509 K10240516 K10240523 K10240530 K10240606 K10240613 K10240702 K11221106 K11221118 K11221128 K11221212 K11221218 K11230108 K11230112 K11230122 K11230129 K11230205 K11230212 K11230226 K11230310 K11230316 K11230323 K11230405 K11230413 K11230420 K11230427 K11230515 K11230518 K11230526 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11230928 K11231012 K11231019 K11231027 K11231109 K11231123 K11231201 K11231207 K11231220 K11240130 K11240131 K11240201 K11240202 K11240208 K11240215 K11240222 K11240229 K11240307 K11240314 K11240327 K11240404 K11240408 K11240411 K11240418 K11240425 K11240502 K11240509 K11240516 K11240523 K11240530 K11240606 K11240613 K12221030 K12221128 K12221212 K12221218 K12230112 K12230122 K12230129 K12230205 K12230212 K12230226 K12230310 K12230316 K12230323 K12230405 K12230413 K12230420 K12230515 K12230518 K12230526 K12230601 K12230608 K12230615 K12230622 K12230706 K12230713 K12230720 K12230727 K12230803 K12230810 K12230817 K12230824 K12230831 K12230907 K12230914 K12230921 K12230928 K12231019 K12231123 K12231201 K12231207 K12231220 K12240130 K12240131 K12240201 K12240202 K12240208 K12240222 K12240307 K12240314 K12240325 K12240327 K12240408 K12240411 K12240418 K12240425 K12240502 K12240509 K12240516 K12240523 K12240530 K13221106 K13221113 K13221128 K13221212 K13221218 K13230112 K13230226 K13230310 K13230316 K13230323 K13230405 K13230413 K13230420 K13230515 K13230518 K13230526 K13230601 K13230713 K13230720 K13230727 K13230803 K13230810 K13230817 K13230914 K13230928 K13231019 K13231116 K13231201 K13231207 K13231220 K13240130 K13240131 K13240201 K13240222 K13240307 K13240314 K13240327 K13240411 K13240418 K13240425 K13240502 K13240509 K13240530 K13240606 K13240613 K14221128 K14221218 K14230112 K14230226 K14230413 K14230420 K14230515 K14230518 K14230601 K14230720 K14230727 K14230803 K14230928 K14231019 K14231116 K14240130 K14240131 K14240201 K14240222 K14240314 K14240327 K14240411 K14240425 K14240502 K14240530 K14240606 K15221128 K15230112 K15230420 K15230515 K15230720 K15230727 K15231116 K15240130 K15240131 K15240201 K15240327 K15240411 K15240502 K15240530 K15240606 K15240613 K16240130 K16240131 K16240201 K16240327 K16240411 K16240508 K17240129 K17240130 K17240131 K17240201 K17240327 K17240508 K18240129 K18240130 K18240201 K18240327 K18240508 K19240129 K19240130 K19240201 K19240327

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 33 of 37

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296

Z-0879-2025
Recall number
Z-0879-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
29,723

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471296 Part Number: 471296-07 UDI-DI code: 00886874121504 Batch Numbers: K10221111 K10221113 K10230112 K10230205 K10230212 K10230217 K10230824 K10240808 K10240822 K11221115 K11230112 K11230217 K12230217 Model Number: 471296 Part Number: 471296-08 UDI-DI code: 00886874121504 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230504 K10230511 K10230601 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231207 K10231218 K10240104 K10240111 K10240118 K10240125 K10240208 K10240222 K10240229 K10240307 K10240314 K10240327 K10240404 K10240411 K10240418 K10240425 K10240516 K10240606 K10240613 K10240620 K10240627 K10240702 K10240711 K10240725 K11230302 K11230310 K11230323 K11230713 K11230831 K11231005 K11231102 K11231116 K11231207 K11240111 K11240208 K11240307 K11240411 K11240418 K11240606 K11240620 K11240711 K12231005 K12240307 K12240620

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 34 of 37

8MM,MEGA SUTURECUT ND,IS4000 REF 471309

Z-0880-2025
Recall number
Z-0880-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
88,840

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471309 Part Number: 471309-15 UDI-DI code: 00886874119815 Batch Numbers: K10221113 K10221115 K10221212 K10221218 K10230103 K10230112 K10230122 K10230124 K10230129 K10230205 K10230212 K10230219 K10230720 K10230824 K10240621 K10240718 K11221113 K11221115 K11221212 K11230103 K11230112 K11230122 K11230202 K11230212 K11230217 K12221113 K12221212 K12230112 K12230122 K12230205 K12230217 K13221113 K13230217 K14230217 K15230217 K16240508 K16240531 U10230217 U10230223 Model Number: 471309 Part Number: 471309-16 UDI-DI code: 00886874119815 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230330 K10230413 K10230420 K10230427 K10230504 K10230509 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230622 K10230630 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230831 K10230913 K10230914 K10230921 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231218 K10240104 K10240111 K10240118 K10240125 K10240215 K10240222 K10240229 K10240308 K10240314 K10240321 K10240322 K10240411 K10240418 K10240425 K10240502 K10240516 K10240523 K10240530 K10240606 K10240613 K10240614 K10240619 K10240711 K10240718 K10240822 K11230302 K11230310 K11230316 K11230323 K11230330 K11230413 K11230420 K11230511 K11230518 K11230601 K11230615 K11230706 K11230713 K11230727 K11230803 K11230810 K11230817 K11230913 K11230914 K11230921 K11231005 K11231012 K11231019 K11231027 K11231102 K11231109 K11231123 K11231130 K11231207 K11231218 K11240104 K11240111 K11240118 K11240125 K11240229 K11240308 K11240314 K11240321 K11240322 K11240411 K11240418 K11240502 K11240516 K11240523 K11240530 K11240606 K11240613 K11240711 K11240718 K11240822 K12230302 K12230310 K12230316 K12230323 K12230413 K12230420 K12230706 K12230810 K12230914 K12230921 K12231005 K12231012 K12231027 K12231109 K12231116 K12231123 K12231130 K12240104 K12240111 K12240118 K12240125 K12240321 K12240411 K12240418 K12240502 K12240516 K12240523 K12240530 K12240606 K12240613 K13230323 K13230914 K13231012 K13231027 K13231109 K13231116 K13240104 K13240111 K13240118 K13240125 K13240502 K13240523 K13240530 K13240606 K14240104 K14240111 K14240125 K14240523 U10230420 U10230426 U10230502 U10230522 U10230630 U10230707 U10230714 U10230824 U10230901 U10230914 U10231016 U10231103 U10231115 U10231120 U11230326 U11230418 U11230707 U11230824 U11230901 U11230914 U11231016 U11231020 U11231103

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 35 of 37

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

Z-0881-2025
Recall number
Z-0881-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
3,869

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471344 Part Number: 471344-17 UDI-DI code: 00886874121511 Batch Numbers: K10230302 K10230310 K10230504 K10230511 K10230525 K10230601 K10230608 K10231019 K10231027 K10231102 K10231218 K10240118 K10240229 K10240411 K10240418 K10240502 K10240509 K10240516 K10240606 K10240627 K10240702 K10240711 K11240418 K16240508

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 36 of 37

8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400

Z-0882-2025
Recall number
Z-0882-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
14,507

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471400 Part Number: 471400-10 UDI-DI code: 00886874121528 Batch Numbers: K10221106 K10221212 K10230129 K10230205 K10230212 K10230219 K10230226 K10230413 K10230504 K10230515 K10230518 K10230525 K10230601 K10230608 K10230615 K10230630 K10230713 K10230720 K10230817 K10230824 K10230831 K10230913 K10230917 K10230928 K10231005 K10231012 K10231019 K10231027 K10231102 K10231130 K10231218 K10240104 K10240116 K10240208 K10240322 K10240327 K10240404 K10240411 K10240516 K10240523 K10240606 K10240613 K10240618 K11221106 K11230129 K11230515 K11230824 K11231012 K11240104 K11240404 K11240702

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

device · product 37 of 37

8MM,FORCE BIPOLAR,IS4000 REF 471405

Z-0883-2025
Recall number
Z-0883-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
46,759

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Code information

Model Number: 471405 Part Number: 471405-06 UDI-DI code: 00886874120767 Batch Numbers: K10221204 K10221212 K10221218 K10230111 K10230212 K10230219 K10230226 K10230302 K10230310 K10230413 K10230420 K10230504 K10230515 K10230518 K10230525 K10230531 K10230601 K10230608 K10230615 K10230622 K10230630 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230914 K10230928 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231218 K10240104 K10240111 K10240118 K10240124 K10240208 K10240215 K10240219 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240415 K10240418 K10240419 K10240425 K10240509 K10240516 K10240520 K10240530 K10240711 K10240728 K10240815 K10240822 K11221204 K11221212 K11221218 K11230212 K11230226 K11230302 K11230310 K11230413 K11230420 K11230515 K11230518 K11230525 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230727 K11230803 K11230810 K11230914 K11231005 K11231019 K11231109 K11231116 K11240104 K11240111 K11240118 K11240208 K11240229 K11240307 K11240411 K11240418 K11240509 K11240516 K11240530 K11240711 K11240815 K11240822 K11240829 K12221204 K12221218 K12230122 K12230212 K12230226 K12230302 K12230515 K12230518 K12230525 K12230608 K12230615 K12230622 K12230706 K12230713 K12230810 K12230914 K12231109 K12240104 K12240118 K12240208 K12240229 K12240307 K12240418 K12240509 K12240530 K12240711 K12240829 K13230212 K13230226 K13230302 K13230525 K13230608 K13230706 K13230713 K13240711 K14230212 K14230226 K14230302 K14230525 K14230706 K14240711 K15230226 K15230525 K16240508 K16240530 U10230626 U10230714 U10230803 U10231201 U10231214 U10240112 U10240126 U11230803

Distribution pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam