Medical Software recalls

908 medical device recalls in the medical software category are on file with the FDA, from 2012 to 30 Sep 2026. The leading reason is device malfunction.

Total recalls908since 2012

Last 12 months138reported

Class I364% of total

Ongoing455latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

4Nov '24 5 15 17Feb 14 15 4May 12 7 2Aug 21 9 9Nov 8 21 26Feb 6 3 6May 17 9 10Aug 14 0

Severity split

Class I 36 4%Class II 852 94%Class III 19 2%Other/pending 1

Why medical software is recalled

Companies

By year

202611212%
202513315%
202410612%
2023435%
2022465%
2021485%
2020566%
2019455%
2018506%
2017506%

Ongoing medical software recalls

455 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Volara System Volara, HC, NA recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg	PTW Freiburg	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA

All medical software recalls, newest first

908 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Volara System Volara, HC, NA recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg	PTW Freiburg	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	Portrait Core Services recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026Device	CLASS II	Philips Incisive CT recalled by Philips Healthcare (Suzhou) Co	Philips Healthcare (Suzhou)	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas	Fujifilm Healthcare Americas	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Portrait Core Services recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Remisol Advance recalled by Beckman Coulter Biomedical	Beckman Coulter Biomedical	Potency & Assay	5 states
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Nerivio Infinity recalled by Theranica Bioelectronics	Theranica Bioelectronics	Device Malfunction
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	Emano Flow recalled by Emano Metrics	Emano Metrics	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	MiniMed Go App recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
22 Jul 2026Device	CLASS II	Rio" II Nasal Pillows Interface recalled by 3B Medical	3B Medical	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS II	Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled	Zimmer Surgical	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled	Zimmer Surgical	Sterility	Nationwide
8 Jul 2026Device	CLASS II	ENFit ExSet Strl 60 PV EN recalled by Medela	Medela	Device Malfunction	18 states

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.