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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
Feb 10, 2023 da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model ... Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the li... Class II Intuitive Surgical, Inc.
Jan 24, 2023 Patient Side Cart, REF: 380620, with instrument arms, used as part of the da ... Preventative maintenance data was used to identify instrument Arms, part of surgical systems, tha... Class II Intuitive Surgical, Inc.
Oct 7, 2022 INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 48... Potential staple deployment failure and device fragment generation Class II Intuitive Surgical, Inc.
Sep 20, 2022 da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devic... Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instr... Class II Intuitive Surgical, Inc.
Jul 1, 2022 Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Cl... Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... Class II Intuitive Surgical, Inc.
Jul 1, 2022 Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Cl... Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... Class II Intuitive Surgical, Inc.
Jun 22, 2022 The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) de... Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar e... Class II Intuitive Surgical, Inc.
Mar 17, 2022 da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Su... As a result of complaint data review, it identified tissue pushout events occurring during firing... Class II Intuitive Surgical, Inc.
Mar 3, 2022 DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument ... Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection c... Class II Intuitive Surgical, Inc.
Mar 3, 2022 VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vin... Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection c... Class II Intuitive Surgical, Inc.
Dec 23, 2021 da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, addi... Class II Intuitive Surgical, Inc.
Sep 22, 2021 da Vinci SP Surgical systems with the following Model Name/ Model Number / UD... Issue was identified during internal engineering evaluation. Use of the system with the affected ... Class II Intuitive Surgical, Inc.
Sep 21, 2021 The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of th... Incorrect expiration date on its package labeling (shipper box and inner carton label). Class II Intuitive Surgical, Inc.
Aug 6, 2021 Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and... Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. Class II Intuitive Surgical, Inc.
Oct 23, 2020 Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usag... The distal tip ring of the fully articulating catheter may become dislodged during the procedure. Class II Intuitive Surgical, Inc.
Jun 10, 2020 ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:0088687... One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... Class II Intuitive Surgical, Inc.
Jun 10, 2020 Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:008868741... One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... Class II Intuitive Surgical, Inc.
Dec 19, 2019 STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-... Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... Class II Intuitive Surgical, Inc.
Dec 19, 2019 STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02... Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... Class II Intuitive Surgical, Inc.
Aug 19, 2019 da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic su... Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing... Class II Intuitive Surgical, Inc.
Jul 26, 2019 da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with... The firm become aware of a potentially defective capacitors on circuit boards installed on certai... Class II Intuitive Surgical, Inc.
Jul 26, 2019 da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product... The firm become aware of a potentially defective capacitors on circuit boards installed on certai... Class II Intuitive Surgical, Inc.
Jul 26, 2019 da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product U... The firm become aware of a potentially defective capacitors on circuit boards installed on certai... Class II Intuitive Surgical, Inc.
Jul 1, 2019 daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI... The firm became aware of a manufacturing variation in which black and green reloads in select Sta... Class II Intuitive Surgical, Inc.
Jul 1, 2019 daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UD... The firm became aware of a manufacturing variation in which black and green reloads in select Sta... Class II Intuitive Surgical, Inc.
Jun 17, 2019 da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601... One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. Th... Class II Intuitive Surgical, Inc.
Apr 1, 2019 da Vinci SP surgical system Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the ... Class II Intuitive Surgical, Inc.
Jan 16, 2019 daVinci Harmonic ACE Curved Shears During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Ha... Class II Intuitive Surgical, Inc.
Dec 4, 2018 Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-... This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments ar... Class II Intuitive Surgical, Inc.
Nov 21, 2018 da Vinci X Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err... Class II Intuitive Surgical, Inc.
Nov 21, 2018 da Vinci Xi Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err... Class II Intuitive Surgical, Inc.
Oct 25, 2018 da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch The instrument drape may tear while draping the Patient Side Cart presenting a breach in the ster... Class II Intuitive Surgical, Inc.
Oct 23, 2018 The da Vinci SP surgical system is made of three main components: the Surgeon... The firm became aware of a problem with the surgical system where the cannula mount button may be... Class II Intuitive Surgical, Inc.
Aug 15, 2018 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 ... Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proxi... Class II Intuitive Surgical, Inc.
Aug 15, 2018 da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 ... Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proxi... Class II Intuitive Surgical, Inc.
Jul 16, 2018 da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS)... Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patien... Class II Intuitive Surgical, Inc.
Jun 4, 2018 EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. ... The firm has identified the potential for a silicone particle to be generated within the Suction ... Class II Intuitive Surgical, Inc.
May 17, 2018 The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Contro... An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibr... Class II Intuitive Surgical, Inc.
Apr 23, 2018 da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box. Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler... Class II Intuitive Surgical, Inc.
Apr 23, 2018 da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box. Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler... Class II Intuitive Surgical, Inc.
Mar 7, 2018 da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Su... Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (A... Class II Intuitive Surgical, Inc.
Sep 19, 2017 daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitiv... Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in ... Class II Intuitive Surgical, Inc.
Jun 1, 2017 da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical Syste... da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentiall... Class II Intuitive Surgical, Inc.
Mar 31, 2017 da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and ... Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da... 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.

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.