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Browse Device Recalls

244 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 244 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 244 FDA device recalls.

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DateProductReasonClassFirm
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Oct 5, 2016 da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software;... Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can resu... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Int... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 14, 2016 CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Sur... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urolo... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The ... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Int... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intu... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
May 9, 2016 SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470... Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula s... Class II Intuitive Surgical, Inc.
May 9, 2016 SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05... Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula s... Class II Intuitive Surgical, Inc.
Mar 25, 2016 EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi syst... Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software... Class II Intuitive Surgical, Inc.
Mar 16, 2016 da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & a... Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... Class II Intuitive Surgical, Inc.
Mar 16, 2016 da Vinci S Surgical System (IS4000) user manual English and OUS. Product U... Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... Class II Intuitive Surgical, Inc.
Feb 16, 2016 da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touch... Class II Intuitive Surgical, Inc.
Nov 23, 2015 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41... This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 m... Class II Intuitive Surgical, Inc.
Nov 23, 2015 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-4... This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 m... Class II Intuitive Surgical, Inc.
Sep 9, 2015 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ... Class II Intuitive Surgical, Inc.
Aug 17, 2015 da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 ... Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Mo... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model num... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Mode... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS300... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model n... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model nu... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Jun 16, 2015 INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical Syste... Field Safety Notification to advise of an issue that may occur involving the combination of the d... Class II Intuitive Surgical, Inc.
May 21, 2015 Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surg... The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of ... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. ... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek M... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. ... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pac... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Me... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical E... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Mic... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. ... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medic... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Mi... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. ... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.
Mar 16, 2015 da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical... Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... Class II Intuitive Surgical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.