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 |
|---|---|---|---|---|
| Aug 4, 2016 | Infant Warmer System (IWS) | GE Healthcare has recently become aware of a potential safety issue related to loose screws in th... | Class II | GE Healthcare, LLC |
| Jul 14, 2016 | Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30... | It was reported by a customer that RadSuite images are not appearing as readable images. Thi... | Class II | Merge Healthcare, Inc. |
| Jun 8, 2016 | GE Healthcare, Discovery MR750w | GE Healthcare has recently become aware of a potential safety issue with the patient bore heating... | Class II | GE Healthcare, LLC |
| May 25, 2016 | iConnect Access software. The firm name on the label is Merge Healthcare, Ha... | Software displayed incorrect prior reports in the viewport area, only when more than one prior st... | Class II | Merge Healthcare, Inc. |
| May 9, 2016 | Optima 1.5T MR430s MR Scanner, a diagnostic imaging device | The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti... | Class II | GE Healthcare, LLC |
| May 9, 2016 | MSK 1.5T Extreme MR Scanner, a diagnostic imaging device | The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti... | Class II | GE Healthcare, LLC |
| May 9, 2016 | GE Revolution CT The system is intended for head, whole body, cardiac and ... | GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can res... | Class II | GE Healthcare, LLC |
| Apr 15, 2016 | GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscop... | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... | Class II | GE Medical Systems, LLC |
| Apr 15, 2016 | Merge LIS software. The firm name on the label is Merge Healthcare. Merge... | There are potential issues with results reporting for certain run-based tests. Under certain con... | Class II | Merge Healthcare, Inc. |
| Apr 15, 2016 | GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscop... | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... | Class II | GE Medical Systems, LLC |
| Apr 13, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | Fetal patient report was automatically pulling prior measurement data for a prior fetus since the... | Class II | Merge Healthcare, Inc. |
| Apr 8, 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS | Reports were missing demographic header information when they were faxed to referring physicians. | Class II | Merge Healthcare, Inc. |
| Apr 8, 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usa... | The software is not adding the correct tomo image. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitor... | In some instances, the system will lock tabs within a study, even when a second user does not hav... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part ... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive software. | The versions allow images to be stored without pixel data, resulting in the system not being able... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is ... | The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting i... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartla... | When taking measurements from images on the Cardio workstation or from the US cart, numbers are n... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger cli... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive when used with RadSuite. The firm name on the la... | The software produced a number of "do not route" exceptions, which may result in potential pati... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Eye Station and Merge Eye Care PACS. | During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may d... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare. | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Me... | System locks up which may result in potential patient injury or delay in diagnosis or treatment. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Potential exists for an incorrect patient image being displayed which could result in the delay i... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software using EchoIMS. The firm name on the label is Merge Hea... | A situation can occur allowing two physicians to access the same study report in EchoIMS when lau... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling i... | An error message can occur resulting in the prior studies being unavailable for viewing. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-0001... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Pr... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software. | Cardio study list does not show STAT studies without refreshing. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hart... | Use of the software may show an incorrect value to the user when viewing the Fractional Flow Rese... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS,... | The system will completely stop allowing the downloading or acquisition of new images due to inco... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge Cardio software. Product Usage: Merge Cardio is a system intended... | If a reader selects Multi-study review prior to the original study completing its loading process... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge Cardio software. Merge Cardio is a system intended to be used to ac... | If images are sent without an order in the system, they will be matched with the latest order on ... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge PACS software. Merge PACS (Picture Archiving Communication System) ... | Cut lines on the image may present horizontally rather than vertically. | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and ... | Eye Station images were not importing properly and were imported under "unknown" due to an issue ... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge PACS software. Product Usage: Merge PACS (Picture Archiving Commu... | The software did not show unviewed images when the last view was skipped. The physician may poten... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic ... | There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo... | Class II | Merge Healthcare, Inc. |
| Mar 15, 2016 | GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation... | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 2... | Class II | GE Medical Systems, LLC |
| Mar 10, 2016 | The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a m... | If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the anal... | Class II | Merge Healthcare, Inc. |
| Feb 17, 2016 | GE Healthcare, Aisys Carestation. | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... | Class II | GE Medical Systems, LLC |
| Feb 17, 2016 | GE Healthcare, Aisys CS2 anesthesia.. | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSp... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The Ligh... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner Syste... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 9, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | A report can be confirmed with the incorrect patient demographics resulting in it being saved und... | Class II | Merge Healthcare, Inc. |
| Feb 5, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Inc., H... | When measuring a lesion on an unmagnified mammography image then performing the same measurement ... | Class II | Merge Healthcare, Inc. |
| Jan 31, 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... | Potential data loss occurs as a result of product archiving not working properly. | Class II | Merge Healthcare, Inc. |
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.