Browse Device Recalls
983 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 983 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 983 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 19, 2019 | Revolution CT scanners Product Usage: The system is intended for head, wh... | Additional low dose radiation exposure. | Class II | GE Healthcare, LLC |
| Dec 28, 2018 | GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model B... | Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when u... | Class II | GE Healthcare, LLC |
| 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 20, 2018 | GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Uni... | When switching back & forth between multiple UV instances in the Windows taskbar, the patient im... | Class II | GE Healthcare, LLC |
| Nov 30, 2018 | System, Tomography Computed Emmission | GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... | Class II | GE Healthcare, LLC |
| Nov 30, 2018 | System, Tomography Computed Emmission | GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... | Class II | GE Healthcare, LLC |
| Nov 15, 2018 | Various GE Magnetic Resonance System on-site software version Product Usag... | Possible incorrect software version loaded. | Class II | GE Healthcare, LLC |
| Nov 9, 2018 | Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, ... | Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and ... | Class II | GE Healthcare, LLC |
| Oct 11, 2018 | Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical im... | Synchronization failure | Class II | GE Healthcare, LLC |
| Oct 11, 2018 | Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundatio... | Synchronization failure | Class II | GE Healthcare, LLC |
| Oct 5, 2018 | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant in... | GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are... | Class II | Ohmeda Medical |
| Oct 5, 2018 | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066... | The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. ... | Class I | GE Healthcare, LLC |
| Sep 27, 2018 | Aisys CS2 Anesthesia System. Sold under the following product names: AISYS,... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 27, 2018 | Touchscreen display kit. Sold under the following product names: TOUCHSCREE... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 27, 2018 | Aisys Anesthesia System. Sold under the following product names: AISYS, AIS... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Panda Wall Mount warmer. Infant radiant warmer | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Panda iRes Infant Radiant Warmer. Device sold under the following product nam... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Giraffe Warmer. Device sold under the following product names: Giraffe Warmer... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the follow... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Panda Freestanding Warmer. Device sold under the following product names: Pa... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Giraffe Incubator Carestation. Neonatal incubator. Device sold under the fol... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 14, 2018 | GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended f... | There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) p... | Class II | GE Healthcare, LLC |
| Sep 14, 2018 | GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH A... | A detector can detach and fall. | Class I | GE Healthcare, LLC |
| Sep 14, 2018 | GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Ca... | A detector can detach and fall. | Class I | GE Healthcare, LLC |
| Sep 14, 2018 | GE Healthcare Millennium MC | A detector can detach and fall. | Class I | GE Healthcare, LLC |
| Sep 11, 2018 | B105/125 Patient Monitor. The device is a portable multiparameter unit to ... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 11, 2018 | PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. ... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 11, 2018 | B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable ... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 11, 2018 | B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 11, 2018 | PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE ... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 10, 2018 | DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision ... | Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion ... | Class II | GE Healthcare Biosciences |
| Sep 4, 2018 | GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CA... | When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... | Class II | GE Healthcare Finland Oy |
| Sep 4, 2018 | GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARE... | When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... | Class II | GE Healthcare Finland Oy |
| Aug 31, 2018 | Solar 8000i Patient Monitoring System is used to monitor physiologic paramet... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Dash 4000 Patient Monitoring System is used to monitor physiologic parameter ... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Dash 3000 Patient Monitoring System is used to monitor physiologic parameter ... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Solar 8000M Patient Monitoring System is used to monitor physiologic paramet... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Solar 9500 Information Monitoring System is used to monitor physiologic para... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Dash 5000 Patient Monitoring System is used to monitor physiologic parameter ... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 30, 2018 | Centricity Universal Viewer with Cross Enterprise Display This impacts produc... | Remote comparison studies displayed may be associated with the wrong patient, without a caution i... | Class II | GE Healthcare, LLC |
| Jul 12, 2018 | Revolution CT systems with the SmartStep Option The system is intended for... | On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on imag... | Class II | GE Healthcare, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the foll... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 12.x, sold under the following pr... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 11.x, sold under the following pr... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| May 25, 2018 | GE Healthcare CARESCAPE Monitor B650 | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overlo... | Class II | GE Healthcare Finland Oy |
| May 24, 2018 | Discovery NM/CT 670 ES, model 5376204-70-57 | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
| 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 | 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 | Discovery NM/CT 670 Pro, model 5376204-70-54 | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
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.