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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
May 21, 2014 Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S Syst... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Connection QRG for the da Vinci Standard Surgical System; da Vinci S System... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 System Manual 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 IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 9, 2014 Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da V... Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to ove... Class II Intuitive Surgical, Inc.
Mar 13, 2014 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Mar 13, 2014 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Mar 13, 2014 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Mar 13, 2014 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Nov 15, 2013 Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, ... Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers ... Class II Intuitive Surgical, Inc.
Nov 15, 2013 Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, ... Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers ... Class II Intuitive Surgical, Inc.
Nov 11, 2013 Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S ... Reports of friction within certain instrument arms can interrupt smooth instrument motion. This c... Class II Intuitive Surgical, Inc.
Oct 21, 2013 da Vinci Vision System Cart, a component of the da Vinci Si Surgical System ... Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompati... Class III Intuitive Surgical, Inc.
Oct 2, 2013 Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94... A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and cu... Class II Intuitive Surgical, Inc.
Oct 2, 2013 Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 ... A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and cu... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Instrument Control Box, model number ICB3000; Manufactured by Int... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuit... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intu... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intui... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
May 8, 2013 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distri... Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors ver... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgic... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical S... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical S... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 6, 2013 da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si S... Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection pr... Class II Intuitive Surgical, Inc.
May 6, 2013 da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical... Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection pr... Class II Intuitive Surgical, Inc.
Mar 15, 2013 IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model I... Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... Class II Intuitive Surgical, Inc.
Mar 15, 2013 IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da ... Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... Class II Intuitive Surgical, Inc.
Jan 24, 2013 User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and... Change to User Manual to remove one indication for use and amend warnings to emphasize restrictio... Class II Intuitive Surgical, Inc.
Aug 9, 2012 Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable... There is potential for the sterility of the product to be compromised. Class II Intuitive Surgical, Inc.
Jul 13, 2012 INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use ... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The inten... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Apr 27, 2012 Patient Side Cart Battery Box used in conjunction with the da Vinci A surgica... Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. Class II Intuitive Surgical, Inc.
Oct 17, 2011 da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which co... Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to ... Class II Intuitive Surgical, Inc.
Oct 13, 2011 Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage:... Promotional literature for use of the da Vinci system for thyroidectomy, which had not been appro... Class II Intuitive Surgical, Inc.
Sep 23, 2011 Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable T... Clarification of existing labeling and related cautions for the tip cover accessory of the da Vin... Class II Intuitive Surgical, Inc.
Sep 19, 2011 Cannula 8MM Regular. Provides the means of introduction and placement of a... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 19, 2011 Flush Port (used in almost all da Vinci instruments) Assists in cleaning t... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 19, 2011 da Vinci Si Surgeon Console. Intended to assist in the accurate Control of... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Dec 11, 1930 Patient Cart used in conjunction with the da Vinci S surgical and SI System. ... Increased number of complaints regarding fluid entering the patient card base of the da Vinci S a... 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.