Browse Device Recalls
797 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 797 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 797 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 16, 2018 | Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir... | This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... | Class II | LivaNova USA Inc |
| Nov 16, 2018 | Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi... | This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... | Class II | LivaNova USA Inc |
| Nov 16, 2018 | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... | Lead impedance values reported by the affected VNS generator will be higher compared to those rep... | Class II | LivaNova USA Inc |
| Oct 16, 2018 | MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PUL... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | MED EL Cochlear Implant System, SONATATIi100, sold under the following implan... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the follo... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version... | software malfunction; It was found when a user performs radiography using the wireless flat pane... | Class II | Canon Medical System, USA, INC. |
| Oct 11, 2018 | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6... | The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed w... | Class II | St. Jude Medical, Inc. |
| Sep 28, 2018 | Dimension Thermal Chamber Motor Cable located in the following models: Model... | Thermal chamber motors have electrical cables with single insulation rather than the required dou... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 5, 2018 | Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMa... | Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of ... | Class II | Thoratec Switzerland GMBH |
| Sep 4, 2018 | Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological ... | Product was assembled with an isolating fiberglass hose within the oven in the wrong position. Th... | Class II | Leica Microsystems, Inc. |
| Aug 28, 2018 | Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardi... | Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board... | Class II | Terumo Cardiovascular Systems Corporation |
| Aug 28, 2018 | Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardi... | Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board... | Class II | Terumo Cardiovascular Systems Corporation |
| Aug 15, 2018 | MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple ... | When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound T... | Class II | Agilent Technologies, Inc. |
| Jun 11, 2018 | NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) ... | There is a potential risk of electrical fire when fluid leaks into the power receptacle on the ba... | Class II | NxStage Medical, Inc. |
| May 25, 2018 | Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Art... | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... | Class II | Siemens Medical Solutions USA, Inc |
| May 25, 2018 | AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is ... | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... | Class II | Siemens Medical Solutions USA, Inc |
| May 24, 2018 | CT Goldseal BrightSpeed 16 PWR TIO 2 YR | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Discovery RT labeled as: a. MID BJG; b. HVY BJG | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalat... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Revolution CT 160 1.5D STD WAUK | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inh... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhala... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Optima CT 540 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Optima CT 520 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery MI Digital Ready | DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be ... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG ... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | CT Goldseal Optima CT 600 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 11, 2018 | Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR C... | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... | Class II | Olsen Medical |
| May 2, 2018 | Heartware Medtronic HVAD System for cardiac use. Including the following pa... | Possible transient electrical connection interruption between an HVAD System power source (Batter... | Class I | Heartware |
| Mar 22, 2018 | GE LOGIQ 9 ultrasound system Product Usage: The device is intended for ... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound s... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is ... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E95 ultrasound system Product The device is intended for use by a... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for u... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultras... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 1, 2018 | Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The p... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: ... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The pr... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Feb 8, 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The... | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outl... | Class II | Stanbio Laboratory, LP |
| Oct 30, 2017 | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the... | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after... | Class II | Sorin Group Deutschland GmbH |
| Oct 20, 2017 | Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with ... | The ultrasound probe may not have adequate protection against electrical shock hazards. | Class II | Hitachi Medical Systems America Inc |
| Oct 12, 2017 | Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Si... | This voluntary recall is being conducted due to the potential for failure to detect the affected... | Class II | Covidien LLC |
| Sep 30, 2017 | O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02... | During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is po... | Class II | Medtronic Navigation, Inc.-Littleton |
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.