Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 11, 2019 | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-H... | The sets are configured with quick connectors that have been assembled in reverse on the arterial... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Jul 11, 2019 | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not s... | Class II | Merge Healthcare, Inc. |
| Jul 11, 2019 | Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not s... | Class II | Merge Healthcare, Inc. |
| Jul 10, 2019 | Spectrum Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | ClubMax Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2K... | There is a potential for low discordant progesterone results on a subset of patient samples. A f... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2019 | Atom Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | Maxim Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Software Security; The action is being initiated because of software security vulnerabilities wi... | Class II | Radiometer America Inc |
| Jul 10, 2019 | Logolas Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 | There is a potential for low discordant progesterone results on a subset of patient samples. A f... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2019 | Burstberry Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is t... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully i... | code 7-102 Liquid Sensor Error | Class II | Phadia Ab |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invas... | The metal cannula are potentially too loose and may become loose when applying the filing material. | Class II | Voco GmbH |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 8, 2019 | BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The ... | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 8, 2019 | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5600 Integrated System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 350 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 4600 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 4600 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III i... | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 8, 2019 | VITROS 250AT Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled ... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD Inc. |
| Jul 8, 2019 | TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Us... | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other... | Class II | CooperSurgical, Inc. |
| Jul 8, 2019 | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | GRIPPER Needles sold individually. Labeled as the following item description... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD 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.