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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 12, 2013 | Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M122... | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... | Class II | GE Healthcare |
| Dec 12, 2013 | GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging sys... | GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D,... | Class II | GE Healthcare, LLC |
| Dec 11, 2013 | GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova... | GE Healthcare has become aware of a potential safety issue involving the innova systems. The Inno... | Class II | GE Healthcare, LLC |
| Dec 5, 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intende... | Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... | Class II | GE Healthcare, LLC |
| Dec 5, 2013 | GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: Th... | Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... | Class II | GE Healthcare, LLC |
| Dec 5, 2013 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc... | Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... | Class II | GE Healthcare, LLC |
| Nov 27, 2013 | GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM)... | GE Healthcare has recently become aware of a potential safety issue due to intermittent failure o... | Class II | GE Healthcare, LLC |
| Nov 27, 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port... | GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash... | Class II | GE Healthcare, LLC |
| Nov 20, 2013 | GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery ... | GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection... | Class II | GE Healthcare, LLC |
| Nov 15, 2013 | GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imagi... | GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imagi... | Class II | GE Healthcare, LLC |
| Nov 8, 2013 | Video Monitor Suspensions that may be on the following Fluoroscopic and Radio... | Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws t... | Class II | GE Healthcare, LLC |
| Nov 7, 2013 | GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiograph... | There exists a software issue associated with patient selection from the worklist on the Optima X... | Class II | GE Healthcare, LLC |
| Oct 25, 2013 | GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo ... | GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan proce... | Class II | GE Healthcare, LLC |
| Oct 11, 2013 | HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40,... | GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings as... | Class II | GE Healthcare, LLC |
| Oct 11, 2013 | GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasoun... | GE became aware of a potential safety issue due to a system slow down and system lock up associat... | Class II | GE Healthcare, LLC |
| Oct 9, 2013 | GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Inten... | There is an issue with the Manual Film Composer feature on some CT products. There is an opportu... | Class II | GE Healthcare, LLC |
| Oct 1, 2013 | GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 1, 2013 | GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: T... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 1, 2013 | GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe S... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Sep 19, 2013 | AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESH... | GE Healthcare has recently become aware of a potential safety issue due to the image orientation ... | Class II | GE Healthcare, LLC |
| Sep 19, 2013 | Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos... | GE Healthcare has recently become aware of a potential safety issue due to air leakage associated... | Class I | GE Healthcare, LLC |
| Sep 18, 2013 | GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus... | GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires ... | Class II | GE Healthcare Beijing , Hangwei Medical Systems... |
| Sep 16, 2013 | GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume ... | GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance ... | Class I | GE Healthcare, LLC |
| Aug 30, 2013 | GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is inte... | GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device... | Class II | GE Healthcare, LLC |
| Aug 28, 2013 | GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Inte... | GE Healthcare has recently become aware of a potential safety issue involving unresponsive button... | Class I | GE Healthcare, LLC |
| Aug 26, 2013 | Merge Mammo is a multi-modality, vendor-neutral digital mammography workstati... | There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo vie... | Class II | GE Healthcare It |
| Aug 16, 2013 | GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100I... | GE Healthcare has become aware of a potential safety issue involving missing screws in the overhe... | Class II | GE Healthcare, LLC |
| Aug 13, 2013 | GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 ... | GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on... | Class II | GE Healthcare, LLC |
| Aug 7, 2013 | GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be u... | GE has recently become aware of a potential safety issue due to the incorrect calculation of the ... | Class II | GE Healthcare, LLC |
| Jul 29, 2013 | Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The D... | GE Healthcare has recently become aware of a potential safety issue involving the pre-operative c... | Class II | GE Healthcare, LLC |
| Jul 18, 2013 | Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 un... | GE Healthcare has become aware of a potential safety issue associated with the use of GE General ... | Class II | Vital Signs Devices, a GE Healthcare Company |
| Jun 19, 2013 | GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The a... | GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS... | Class II | GE Healthcare, LLC |
| Jun 13, 2013 | Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Cam... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intend... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is inten... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 11, 2013 | The Centricity PACS Workstation is intended for use as a primary diagnostic a... | GE has recently become aware of potential issues due to out of context issues associated with spe... | Class II | GE Healthcare It |
| May 14, 2013 | Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or ... | GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 ab... | Class II | GE Healthcare, LLC |
| May 9, 2013 | GE Healthcare, PET VCAR. PET VCAR application software is affected if inst... | GE Healthcare has recently become aware of a potential safety issue with respect to the automated... | Class II | GE Healthcare, LLC |
| May 6, 2013 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Multiple studies were missing at a customer location that never made it to the archive before wat... | Class II | Merge Healthcare, Inc. |
| May 2, 2013 | GE Healthcare, Precision 500D Product Usage: The Precision 500D is design... | GE Healthcare has recently become aware of a potential safety issue involving the overhead Video ... | Class II | GE Healthcare, LLC |
| Apr 19, 2013 | Centricity Enterprise Archive is a software product for receiving, archiving ... | GE Healthcare has become aware of a potential data loss issue associated with empty path names re... | Class II | Ge Healthcare It |
| Apr 10, 2013 | The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybr... | GE Healthcare has recently become aware of an incident where the wrong part of the patient body w... | Class II | GE Healthcare, LLC |
| Apr 9, 2013 | GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the fol... | GE Healthcare has recently become aware of a potential safety issue due to non-unique series iden... | Class II | GE Healthcare, LLC |
| Apr 3, 2013 | GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage... | GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... | Class II | GE Healthcare, LLC |
| Apr 3, 2013 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Health... | GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... | Class II | GE Healthcare, LLC |
| Apr 3, 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The int... | GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... | 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.