Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

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.

Clear
DateProductReasonClassFirm
Mar 16, 2015 da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Med... 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, 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 3, 2015 da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 3806... Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... Class II Intuitive Surgical, Inc.
Mar 3, 2015 da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Materi... Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... Class II Intuitive Surgical, Inc.
Mar 3, 2015 da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material... Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... Class II Intuitive Surgical, Inc.
Feb 16, 2015 Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000)... There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have... Class II Intuitive Surgical, Inc.
Feb 11, 2015 EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with th... Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to... Class II Intuitive Surgical, Inc.
Feb 11, 2015 EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da V... Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to... Class II Intuitive Surgical, Inc.
Jan 21, 2015 HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with th... Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... Class II Intuitive Surgical, Inc.
Jan 21, 2015 HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use ... Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... Class II Intuitive Surgical, Inc.
Jan 15, 2015 da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 Sy... The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inc... Class II Intuitive Surgical, Inc.
Dec 5, 2014 IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgic... Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vi... Class II Intuitive Surgical, Inc.
Nov 21, 2014 Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen... The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging... Class II Intuitive Surgical, Inc.
Nov 21, 2014 Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen... The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate cont... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate con... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate contr... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuit... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Int... Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause su... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control ... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control ... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of I... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control o... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intu... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intu... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate contro... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuit... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitiv... Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause su... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of ... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of I... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuiti... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Sep 18, 2014 EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: I... Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discont... Class II Intuitive Surgical, Inc.
Sep 17, 2014 EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical... Intuitive Surgical is initiating a voluntary correction relating to the labeling and software ass... Class II Intuitive Surgical, Inc.
Sep 11, 2014 ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System... Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of ... Class II Intuitive Surgical, Inc.
Jun 13, 2014 Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction wi... Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the inst... Class II Intuitive Surgical, Inc.
Jun 11, 2014 IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Int... In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... Class II Intuitive Surgical, Inc.
Jun 11, 2014 IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Int... In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... Class II Intuitive Surgical, Inc.
Jun 2, 2014 EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWri... Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Man... Class II Intuitive Surgical, Inc.
May 21, 2014 Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinc... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S Sys... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System an... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... 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.