Browse Device Recalls

1,000 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,000 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 1,000 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 14, 2024 SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Reso... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, R... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magneti... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1,... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 t... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR3... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
May 2, 2024 GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) ... GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... Class II GE Vingmed Ultrasound As
May 2, 2024 GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... Class II GE Vingmed Ultrasound As
Apr 9, 2024 GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ON... Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. Class II GE Medical Systems Information Technologies Inc
Apr 5, 2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001,... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c)... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Mar 18, 2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Innova IGS 5, computed tomography x-ray system GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Dec 29, 2023 EVair air compressor, model numbers: M1230849 and M1230847 GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... Class I Datex-Ohmeda, Inc.
Dec 29, 2023 EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230... GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... Class I Datex-Ohmeda, Inc.
Dec 29, 2023 EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... Class I Datex-Ohmeda, Inc.
Dec 26, 2023 GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lulla... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: ... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 100... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 22, 2023 GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ul... GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Pr... Class II GE HEALTHCARE AUSTRIA GMBH & CO
Nov 7, 2023 The System is designed as a modular system with components that include an Ov... GE HealthCare has become aware of the potential that incorrect torque has been applied to certain... Class II GE Hangwei Medical Systems, Co. LTD
Nov 7, 2023 The System is designed as a modular system with components that include an Ov... GE HealthCare has become aware of the potential that incorrect torque has been applied to certain... Class II GE Hangwei Medical Systems, Co. LTD
Nov 1, 2023 Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a c... Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share... Class II CHANGE HEALTHCARE CANADA COMPANY
Oct 12, 2023 Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2... Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.... Class II CHANGE HEALTHCARE CANADA COMPANY
Sep 14, 2023 Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica... GE HealthCare has become aware of an issue where images from two different patients may be contai... Class II GE Healthcare
Sep 14, 2023 Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Rad... GE HealthCare has become aware of an issue where images from two different patients may be contai... Class II GE Healthcare
Sep 14, 2023 Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW found... GE HealthCare has become aware of an issue where images from two different patients may be contai... Class II GE Healthcare
Sep 8, 2023 Centricity Universal Viewer Workflow Manager, Image processing radiological s... When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... Class II GE Healthcare
Sep 8, 2023 Universal Viewer Workflow Manager, Image processing radiological system When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... Class II GE Healthcare

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.