Browse Device Recalls
93 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 93 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 93 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 11, 2025 | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions ... | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schill... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| 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. |
| Aug 6, 2020 | Merge PACS | Measurements done on the Merge PACS generated MPR s may have incorrect measurements. | Class II | Merge Healthcare, Inc. |
| May 8, 2020 | Merge Healthcare Merge Application Server Software Release and Merge Healthca... | An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score c... | Class II | Merge Healthcare, Inc. |
| Jul 11, 2019 | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not s... | Class II | Merge Healthcare, Inc. |
| Jul 11, 2019 | Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not s... | Class II | Merge Healthcare, Inc. |
| Dec 20, 2018 | The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DC... | Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds... | Class II | Merge Healthcare, Inc. |
| Aug 14, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Aug 7, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Jun 13, 2017 | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution fo... | When the user has not set up any user preference on the sorting order to render the study images ... | Class II | Merge Healthcare, Inc. |
| May 24, 2017 | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha... | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... | Class II | Merge Healthcare, Inc. |
| May 24, 2017 | Merge OrthoPACS software. | A migrated study that has annotations will display the annotations, but when a prior study is loa... | Class II | Merge Healthcare, 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 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. |
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.