Browse Device Recalls

922 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 922 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 922 FDA device recalls in WI.

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DateProductReasonClassFirm
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
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 Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is ... the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and ma... Class II Accuray Incorporated
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 28, 2018 The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARES... The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. Class II Datex-Ohmeda, Inc.
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
Jun 6, 2018 Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the fol... GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclea... Class II GE Medical Systems, LLC
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
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 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 NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, l... 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 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 2, 2018 AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N u... The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially ... Class II Ad-Tech Medical Instrument Corporation
Apr 10, 2018 CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic R... There is an unintended drop of a secondary collimator housing that can occur during housing Xchan... Class II Accuray Incorporated
Apr 10, 2018 CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery Syste... There is an unintended drop of a secondary collimator housing that can occur during housing Xchan... Class II Accuray Incorporated
Apr 2, 2018 T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercis... A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 202618... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 30, 2018 MR Surgical Suite Option Product The MR Surgical Option when integrated wi... There is a potential safety issue with the table transfer release of the MR Surgical Suite System... Class II GE Medical Systems, LLC
Mar 29, 2018 Access Hi-Low Exam Tables, Model 6501-XX One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical ... Class II Brewer Company, LLC
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...

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.