Merge Healthcare recalls
Merge Healthcare has 96 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 2 Sep 2026. 9 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is device malfunction.
Total recalls 96 since 2014
Last 12 months 3 reported
Class I 0 0% of total
Ongoing 9 latest 2 Sep 2026
Recalls per month, last 24 months click a bar for that month
Severity split
Class I 0 0% Class II 96 100% Class III 0 0%
Why merge healthcare is recalled
Ongoing merge healthcare recalls 9 active
All merge healthcare recalls, newest first 96 total
Reported Class Recall Company Reason Where 2 Sep 2026 Device CLASS II Merge PACS and Merge OrthoPACS recalled by Merge Healthcare Merge Healthcare Labeling Errors Nationwide 12 Aug 2026 Device CLASS II Merge OrthoPACS, medical imaging diagnostic workstation recalled Merge Healthcare Other Nationwide 12 Aug 2026 Device CLASS II Merge PACS, medical imaging diagnostic workstation recalled Merge Healthcare Other Nationwide 10 Sep 2025 Device CLASS II The Merge Hemo recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 26 Mar 2025 Device CLASS II Vericis, Merge Cardio recalled by Merge Healthcare Merge Healthcare Device Malfunction WI 26 Mar 2025 Device CLASS II Vericis, Merge Cardio recalled by Merge Healthcare Merge Healthcare Device Malfunction WI 26 Mar 2025 Device CLASS II Merge Cardio recalled by Merge Healthcare Merge Healthcare Device Malfunction WI 26 Mar 2025 Device CLASS II Vericis, Merge Cardio recalled by Merge Healthcare Merge Healthcare Device Malfunction WI 26 Mar 2025 Device CLASS II Vericis, Merge Cardio recalled by Merge Healthcare Merge Healthcare Device Malfunction WI 8 Sep 2021 Device CLASS II Merge Hemo recalled by Merge Healthcare Merge Healthcare Device Malfunction WI 4 Nov 2020 Device CLASS II Merge LIS recalled by Merge Healthcare Merge Healthcare Device Malfunction 15 states 16 Sep 2020 Device CLASS II Merge PACS recalled by Merge Healthcare Merge Healthcare Other 25 states 1 Jul 2020 Device CLASS II Merge Application Server recalled by Merge Healthcare Merge Healthcare Labeling Errors Nationwide 31 Jul 2019 Device CLASS II Merge PACS versions 7.3, 7.3.1 recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 31 Jul 2019 Device CLASS II Merge OrthoPACS versions 7.3, 7.3.1 recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 6 Mar 2019 Device CLASS II The WinStation Retinal Imager, also known as Merge Eye Station recalled Merge Healthcare Packaging Defects Nationwide 8 Aug 2018 Device CLASS II Merge Unity recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 24 Jan 2018 Device CLASS II Fellows "Mighty 8" Power strip recalled by Merge Healthcare Merge Healthcare Other Nationwide 13 Sep 2017 Device CLASS II Merge Unity recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 26 Jul 2017 Device CLASS II Merge Eye Care Pacs Viewer 5.2 Merge Eye Care Pacs recalled Merge Healthcare Device Malfunction 9 states 19 Jul 2017 Device CLASS II The Schiller PB 1000, also known as Merge Hemo Patient Data recalled Merge Healthcare Device Malfunction Nationwide 5 Jul 2017 Device CLASS II Merge LIS recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 5 Jul 2017 Device CLASS II MasimoSET LNOP DCI adult SpO2 reusable sensor recalled Merge Healthcare Temperature Abuse Nationwide 5 Jul 2017 Device CLASS II MasimoSET Lnop Dcip pediatric/slender digit SpO2 reusable recalled Merge Healthcare Temperature Abuse Nationwide 5 Jul 2017 Device CLASS II SpO2 connecting cable for Masimo LNCS sensor (Merge recalled Merge Healthcare Temperature Abuse Nationwide 5 Jul 2017 Device CLASS II Masimo SPO2 Sensor, ear clip-adult (Merge recalled by Merge Healthcare Merge Healthcare Temperature Abuse Nationwide 28 Jun 2017 Device CLASS II Merge OrthoPACS recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 28 Jun 2017 Device CLASS II Merge OrthoPACS recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 21 Jun 2017 Device CLASS II Merge PACS recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide 21 Jun 2017 Device CLASS II Merge PACS recalled by Merge Healthcare Merge Healthcare Device Malfunction Nationwide
Load more (66 more)
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.