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 |
|---|---|---|---|---|
| May 19, 2017 | GE Healthcare Optima CT660, CT680 X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Discovery NM/CT 670 CZT X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Discovery Ml X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Lightspeed RT16 X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare LightSpeed VCT X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Discovery IQ X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Optima CT540 X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Discovery Ml DR X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Discovery NM/CT 570c X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare BrightSpeed X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare lnnova IGS 540 ACT X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 19, 2017 | GE Healthcare Optima CT520 X-ray system | It was discovered that an issue has been identified that can result in a scan starting before the... | Class II | GE Healthcare, LLC |
| May 15, 2017 | Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-0... | Potential for electric shock in the case of a failure to install the grommets, supplied with the ... | Class II | Perkinelmer Life Sciences, Inc. |
| May 8, 2017 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk... | Class II | Merge Healthcare, Inc. |
| May 8, 2017 | Merge PACS software. Merge PACS (Picture Archiving Communication System) is... | When cut lines are shown on an image, the lines may go from being vertical and then shift to hori... | Class II | Merge Healthcare, Inc. |
| May 5, 2017 | Infant Warmer System (IWS) | GE Healthcare has recently become aware of a potential safety issue related to loose screws in t... | Class II | GE Healthcare, LLC |
| May 2, 2017 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction | Class II | GE Healthcare, LLC |
| Apr 6, 2017 | Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power s... | Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLi... | Class II | Merge Healthcare, Inc. |
| Mar 10, 2017 | Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. | GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly... | Class II | GE Healthcare, LLC |
| Mar 10, 2017 | Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. | GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly... | Class II | GE Healthcare, LLC |
| Feb 6, 2017 | Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems | Reported incidents of a patient step detaching from the table. A fall from a patient step detach... | Class II | GE Healthcare, LLC |
| Jan 23, 2017 | Merge LIS | A defect in the software resulted in medications that are not associated with the patient (i.e., ... | Class II | Merge Healthcare, Inc. |
| Jan 20, 2017 | Discovery MR450 The systems are whole body magnetic resonance scanners des... | Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI.... | Class II | GE Healthcare, LLC |
| Dec 27, 2016 | OEC 9800. MDL Numbers: D222250, D141598 | GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ... | Class II | GE OEC Medical Systems, Inc |
| Dec 27, 2016 | OEC 9900 Elite. MDL Numbers: D148942, D155043 | GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ... | Class II | GE OEC Medical Systems, Inc |
| Dec 19, 2016 | The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluorosco... | GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... | Class II | GE OEC Medical Systems, Inc |
| Dec 19, 2016 | OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile ... | GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... | Class II | GE OEC Medical Systems, Inc |
| Dec 19, 2016 | OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide ... | GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... | Class II | GE OEC Medical Systems, Inc |
| Dec 9, 2016 | Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStat... | This recall has been initiated due to an issue related to the potential accidental deletion of re... | Class II | Merge Healthcare, Inc. |
| Dec 9, 2016 | Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinSt... | Merge received reports of Merge Eye Station being unable to capture images of the eye as expected... | Class II | Merge Healthcare, Inc. |
| Nov 21, 2016 | Prestige II | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | SFX | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | ADVANTX LCN+ | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | ADVANTX LCLP+ | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | Legacy | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | Innova 2000 | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | Prestilix | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | ADVANTX LCV+ | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | RFX | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | Prestige SI | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | ADVANTX LCA | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | Precision 500D | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 21, 2016 | Prestige VH | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... | Class II | GE Healthcare, LLC |
| Nov 3, 2016 | GE Healthcare, Avance, Avance CS2, Amingo. | GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and A... | Class II | GE Healthcare, LLC |
| Oct 20, 2016 | Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a... | A product issues happens for RF projection images. If user measures on RF image, .cal (Calibratio... | Class II | Merge Healthcare, Inc. |
| Sep 23, 2016 | OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Produc... | GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 6... | Class II | GE OEC Medical Systems, Inc |
| Sep 16, 2016 | Brivo XR385, model 5215463, Digital Diagnostic Radiographic System | The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can i... | Class II | GE Healthcare, LLC |
| Aug 31, 2016 | GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. | GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involv... | 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.