Browse Device Recalls
780 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 780 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 780 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 13, 2020 | Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bo... | Hairline fractures in a component could allow electrical current to arc out of the device, result... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jan 13, 2020 | SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The pr... | Hairline fractures in a component could allow electrical current to arc out of the device, result... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Oct 14, 2019 | Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Labe... | Due to the potential for fluid ingress into the Arm which could affect the device's electrical sy... | Class II | Mizuho OSI |
| Oct 11, 2019 | ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product ... | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system ha... | Class II | LIFELINES NEURO COMPANY |
| Oct 11, 2019 | ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usag... | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system ha... | Class II | LIFELINES NEURO COMPANY |
| Oct 4, 2019 | Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System... | The firm became aware of a cleaning solution leaking issue from the middle staining module of the... | Class II | Ventana Medical Systems Inc |
| Sep 19, 2019 | TherMax Blood Warmer Unit | TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires... | Class II | Baxter Healthcare Corporation |
| Sep 16, 2019 | CardioLab/ComboLab Recording Systems | Potential for failure of the patient leakage current test. There is a potential that if another d... | Class II | GE Healthcare, LLC |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Jul 3, 2019 | CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Elect... | Possible mis-labeling of the device with incorrect serial number labels which may result in a pat... | Class II | Capso Vision, Inc. |
| Jun 20, 2019 | ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: ... | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: ... | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: ... | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| May 28, 2019 | The ICS CHARTR EP 200 | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical... | Class II | GN Otometrics |
| May 21, 2019 | The Alinity ci-series System Control Modules which are configured with Alinit... | All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... | Class II | Abbott Gmbh & Co. KG |
| Apr 24, 2019 | ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 23, 2019 | LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The... | 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appr... | Class II | CooperSurgical, Inc. |
| Apr 16, 2019 | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth El... | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon en... | Class II | Ad-Tech Medical Instrument Corporation |
| Apr 4, 2019 | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085... | The manufacturer received complaints that customers were attempting to install the fitting softwa... | Class III | Advanced Bionics, LLC |
| Mar 25, 2019 | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energiza... | Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electr... | Class II | Philips Medical Systems Nederlands |
| Mar 21, 2019 | EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usag... | Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress i... | Class I | Edwards Lifesciences, LLC |
| Mar 20, 2019 | Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ... | Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes | Class III | GETINGE US SALES LLC |
| Mar 7, 2019 | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R7... | Potential performance issues in the Alinity-ci software version 2.5.1 | Class II | Abbott Gmbh & Co. KG |
| Mar 4, 2019 | Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Produ... | The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. | Class III | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 26, 2019 | Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c... | The safety interlock covering the septum piercing probes within the bulk solution bottle holder m... | Class II | Abbott Gmbh & Co. KG |
| Jan 17, 2019 | Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer | There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 po... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 20, 2018 | The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DC... | Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds... | Class II | Merge Healthcare, Inc. |
| Dec 17, 2018 | BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnos... | Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating ... | Class II | Stryker Sustainability Solutions |
| Nov 19, 2018 | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600... | HVAD Battery Charger units manufactured with wrong inductors. | Class II | Heartware, Inc. |
| 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 |
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.