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Intuitive Surgical, Inc.

218 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 recall (Z-2722-2026)Intuitive Surgical, Inc.2026-07-10
Da Vinci ASSY, PSS, SP1098, Part Number: 380601 recall (Z-2521-2026)Intuitive Surgical, Inc.2026-06-22
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 So recall (Z-2310-2026)Intuitive Surgical, Inc.2026-06-04
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 recall (Z-1855-2026)Intuitive Surgical, Inc.2026-05-01
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/ recall (Z-2046-2026)Intuitive Surgical, Inc.2026-05-01
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S a recall (Z-1696-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, recall (Z-1697-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega recall (Z-1698-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Gras recall (Z-1699-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenac recall (Z-1700-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si recall (Z-1701-2026)Intuitive Surgical, Inc.2026-03-30
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invas recall (Z-1428-2026)Intuitive Surgical, Inc.2026-02-18
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730- recall (Z-1355-2026)Intuitive Surgical, Inc.2026-02-12
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical S recall (Z-1232-2026)Intuitive Surgical, Inc.2026-02-02
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number recall (Z-1134-2026)Intuitive Surgical, Inc.2026-01-21
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, recall (Z-1096-2026)Intuitive Surgical, Inc.2026-01-15
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Numb recall (Z-0964-2026)Intuitive Surgical, Inc.2025-12-19
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalo recall (Z-1325-2025)Intuitive Surgical, Inc.2025-03-12
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems recall (Z-0923-2025)Intuitive Surgical, Inc.2025-01-16
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/ recall (Z-0924-2025)Intuitive Surgical, Inc.2025-01-16
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 recall (Z-0847-2025)Intuitive Surgical, Inc.2025-01-10
8MM, POTTS SCISSORS, IS4000 REF 470001 recall (Z-0848-2025)Intuitive Surgical, Inc.2025-01-10
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 recall (Z-0849-2025)Intuitive Surgical, Inc.2025-01-10
8MM, ROUND TIP SCISSORS, IS4000 REF 470007 recall (Z-0850-2025)Intuitive Surgical, Inc.2025-01-10
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033 recall (Z-0851-2025)Intuitive Surgical, Inc.2025-01-10
8MM,DEBAKEY FORCEPS,IS4000 REF 470036 recall (Z-0852-2025)Intuitive Surgical, Inc.2025-01-10
8MM,CADIERE FORCEPS,IS4000 REF 470049 recall (Z-0853-2025)Intuitive Surgical, Inc.2025-01-10
8MM,PROGRASP FORCEPS,IS4000 REF 470093 recall (Z-0854-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171 recall (Z-0855-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172 recall (Z-0856-2025)Intuitive Surgical, Inc.2025-01-10
8MM,RESANO FORCEPS,IS4000 REF 470181 recall (Z-0857-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194 recall (Z-0858-2025)Intuitive Surgical, Inc.2025-01-10
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205 recall (Z-0859-2025)Intuitive Surgical, Inc.2025-01-10
8MM,TENACULUM FORCEPS,IS4000 REF 470207 recall (Z-0860-2025)Intuitive Surgical, Inc.2025-01-10
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230 recall (Z-0861-2025)Intuitive Surgical, Inc.2025-01-10
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246 recall (Z-0862-2025)Intuitive Surgical, Inc.2025-01-10
8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249 recall (Z-0863-2025)Intuitive Surgical, Inc.2025-01-10
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296 recall (Z-0864-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MEGA SUTURECUT ND,IS4000 REF 470309 recall (Z-0865-2025)Intuitive Surgical, Inc.2025-01-10
8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318 recall (Z-0866-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327 recall (Z-0867-2025)Intuitive Surgical, Inc.2025-01-10
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344 recall (Z-0868-2025)Intuitive Surgical, Inc.2025-01-10
8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347 recall (Z-0869-2025)Intuitive Surgical, Inc.2025-01-10
8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401 recall (Z-0870-2025)Intuitive Surgical, Inc.2025-01-10
8MM,FORCE BIPOLAR,IS4000 REF 470405 recall (Z-0871-2025)Intuitive Surgical, Inc.2025-01-10
8MM,LONG TIP FORCEPS,IS4000 REF 471048 recall (Z-0872-2025)Intuitive Surgical, Inc.2025-01-10
8MM,CADIERE FORCEPS,IS4000 REF 471049 recall (Z-0873-2025)Intuitive Surgical, Inc.2025-01-10
8MM,PROGRASP FORCEPS,IS4000 REF 471093 recall (Z-0874-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 recall (Z-0875-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 recall (Z-0876-2025)Intuitive Surgical, Inc.2025-01-10
8MM,COBRA GRASPER,IS4000 REF 471190 recall (Z-0877-2025)Intuitive Surgical, Inc.2025-01-10
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 recall (Z-0878-2025)Intuitive Surgical, Inc.2025-01-10
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 recall (Z-0879-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MEGA SUTURECUT ND,IS4000 REF 471309 recall (Z-0880-2025)Intuitive Surgical, Inc.2025-01-10
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 recall (Z-0881-2025)Intuitive Surgical, Inc.2025-01-10
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 recall (Z-0882-2025)Intuitive Surgical, Inc.2025-01-10
8MM,FORCE BIPOLAR,IS4000 REF 471405 recall (Z-0883-2025)Intuitive Surgical, Inc.2025-01-10
Ion Endoluminal System, REF: 380748-65 recall (Z-2720-2024)Intuitive Surgical, Inc.2024-08-23
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 recall (Z-1518-2024)Intuitive Surgical, Inc.2024-04-11
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm recall (Z-0406-2024)Intuitive Surgical, Inc.2023-11-28
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 recall (Z-2059-2023)Intuitive Surgical, Inc.2023-06-30
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 recall (Z-1293-2023)Intuitive Surgical, Inc.2023-03-28
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgi recall (Z-1262-2023)Intuitive Surgical, Inc.2023-03-16
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIV recall (Z-0340-2023)Intuitive Surgical, Inc.2022-11-30
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Co recall (Z-0133-2023)Intuitive Surgical, Inc.2022-10-25
da Vinci SP surgical system recall (Z-2260-2020)Intuitive Surgical, Inc.2020-06-03
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is des recall (Z-2630-2017)Intuitive Surgical, Inc.2017-06-06
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBE recall (Z-1819-2017)Intuitive Surgical, Inc.2017-04-13
da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and P recall (Z-0315-2017)Intuitive Surgical, Inc.2016-10-26
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical d recall (Z-2675-2016)Intuitive Surgical, Inc.2016-08-26
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgica recall (Z-2676-2016)Intuitive Surgical, Inc.2016-08-26
CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuit recall (Z-2677-2016)Intuitive Surgical, Inc.2016-08-26
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical d recall (Z-2348-2016)Intuitive Surgical, Inc.2016-08-05
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical recall (Z-2349-2016)Intuitive Surgical, Inc.2016-08-05
CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive recall (Z-2350-2016)Intuitive Surgical, Inc.2016-08-05
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 47036 recall (Z-1836-2016)Intuitive Surgical, Inc.2016-05-27
SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; recall (Z-1837-2016)Intuitive Surgical, Inc.2016-05-27
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and recall (Z-0652-2016)Intuitive Surgical, Inc.2016-01-14
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and recall (Z-0653-2016)Intuitive Surgical, Inc.2016-01-14
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Mod recall (Z-2782-2015)Intuitive Surgical, Inc.2015-09-17
Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428 recall (Z-2750-2015)Intuitive Surgical, Inc.2015-09-10
Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numb recall (Z-2751-2015)Intuitive Surgical, Inc.2015-09-10
Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055 recall (Z-2752-2015)Intuitive Surgical, Inc.2015-09-10
Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-1 recall (Z-2753-2015)Intuitive Surgical, Inc.2015-09-10
Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058- recall (Z-2754-2015)Intuitive Surgical, Inc.2015-09-10
Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 4280 recall (Z-2755-2015)Intuitive Surgical, Inc.2015-09-10
Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model number recall (Z-2756-2015)Intuitive Surgical, Inc.2015-09-10
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 4 recall (Z-2757-2015)Intuitive Surgical, Inc.2015-09-10
Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model num recall (Z-2758-2015)Intuitive Surgical, Inc.2015-09-10
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and recall (Z-2734-2015)Intuitive Surgical, Inc.2015-09-03
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuit recall (Z-1949-2015)Intuitive Surgical, Inc.2015-07-01
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. recall (Z-1812-2015)Intuitive Surgical, Inc.2015-06-17
da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes a recall (Z-1380-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment D recall (Z-1381-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drape recall (Z-1382-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical E recall (Z-1383-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Eq recall (Z-1384-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment recall (Z-1385-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Dra recall (Z-1386-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek M recall (Z-1387-2015)Intuitive Surgical, Inc.2015-04-06
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