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.

Clear
DateProductReasonClassFirm
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSp... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Nov 19, 2021 Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU T... The Instructions for Use provided with the device contained information intended for use of a mec... Class III Ki Mobility Llc
Nov 4, 2021 GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" The firm identified that the Vscan Extend device will not power on because of depleted battery, d... Class II GE Healthcare, LLC
Nov 4, 2021 GE Vscan Extend, being sold as "Vscan Extend Console" The firm identified that the Vscan Extend device will not power on because of depleted battery, d... Class II GE Healthcare, LLC
Nov 4, 2021 GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" The firm identified that the Vscan Extend device will not power on because of depleted battery, d... Class II GE Healthcare, LLC
Nov 4, 2021 GE Vscan Extend, being sold as "Vscan Extend Sector USB" The firm identified that the Vscan Extend device will not power on because of depleted battery, d... Class II GE Healthcare, LLC
Nov 4, 2021 GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" The firm identified that the Vscan Extend device will not power on because of depleted battery, d... Class II GE Healthcare, LLC
Nov 4, 2021 GE Vscan Extend, being sold as "Vscan Extend Dual USB" The firm identified that the Vscan Extend device will not power on because of depleted battery, d... Class II GE Healthcare, LLC
Nov 4, 2021 GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" The firm identified that the Vscan Extend device will not power on because of depleted battery, d... Class II GE Healthcare, LLC
Oct 29, 2021 Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity ... M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2... Class II Diversatek Healthcare
Oct 15, 2021 GE Centricity Universal Viewer Zero Footprint Client There is a potential to display incomplete patient imaging study. Class II GE Healthcare, LLC
Sep 3, 2021 ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLB... The devices malfunction under specific operator workflows. Class II Welch Allyn Inc Mortara
Aug 26, 2021 SIGNA Premier nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 Discovery MR750 3.0T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Artist nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Voyager nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 Discovery MR750w 3.0T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Architect nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 Optima MR450w 1.5T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Pioneer nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 12, 2021 Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image proce... A software anomaly exists in the Centricity Universal Viewer study management feature in which st... Class II GE Healthcare, LLC
Aug 9, 2021 Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connect... Incorrect version of labels were used. Class II Ad-Tech Medical Instrument Corporation
Aug 9, 2021 Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of... Incorrect version of labels were used. Class II Ad-Tech Medical Instrument Corporation
Aug 9, 2021 Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpo... Incorrect version of labels were used. Class II Ad-Tech Medical Instrument Corporation
Aug 6, 2021 Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that di... Image acquisition failures and synchronization failure with the Centricity Enterprise Archive Class II GE Healthcare, LLC
Aug 6, 2021 Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that ... Image acquisition failures and synchronization failure with the Centricity Enterprise Archive Class II GE Healthcare, LLC
Aug 2, 2021 Flow sensors kept as stand-alone user replaceable spare parts for the GEHC an... The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t... Class II GE Healthcare, LLC
Aug 2, 2021 Flow sensors that may be installed in the following GEHC anesthesia machines:... The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t... Class II GE Healthcare, LLC
Jul 23, 2021 Merge Hemo, Software packages 10.2, 10.3, and 10.4 The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x... Class II Merge Healthcare, Inc.
Jun 30, 2021 Revolution CT, Revolution CT ES The accumulated dose is incorrectly displayed in certain situations. There are two situations tha... Class II GE Healthcare, LLC
Jun 30, 2021 The system is intended to produce cross-sectional images of the body by compu... When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... Class II GE Healthcare, LLC
Jun 30, 2021 Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution ... The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interve... Class II GE Healthcare, LLC
Jun 30, 2021 The system is intended to produce cross-sectional images of the body by compu... When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... Class II GE Healthcare, LLC
Jun 30, 2021 Revolution Apex, Revolution CT with Apex Edition The accumulated dose is incorrectly displayed in certain situations. There are two situations tha... Class II GE Healthcare, LLC
Jun 30, 2021 The system is intended to produce cross-sectional images of the body by compu... When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... Class II GE Healthcare, LLC
Jun 24, 2021 AMX Navigate Mobile X-Ray System An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray ... Class II GE Healthcare, LLC
Jun 14, 2021 Revolution EVO, Optima CT660, Optima CT680 CT Systems. Improperly loaded software options may result in additional X -ray radiation exposure to the pati... Class II GE Healthcare, LLC
Jun 4, 2021 SIGNA Voyager, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where t... Class II GE Healthcare, LLC
Jun 4, 2021 SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner des... GE Healthcare has recently become aware of an issue on the affected products listed below where t... Class II GE Healthcare, LLC
Jun 4, 2021 SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner d... GE Healthcare has recently become aware of an issue on the affected products listed below where t... Class II GE Healthcare, LLC
Jun 4, 2021 SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where t... Class II GE Healthcare, LLC
Jun 4, 2021 Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scan... GE Healthcare has recently become aware of an issue on the affected products listed below where t... Class II GE Healthcare, LLC
Jun 4, 2021 Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where t... 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.