Medical Software recalls

933 medical device recalls in the medical software category are on file with the FDA, from 2012 to 21 Oct 2026. The leading reason is device malfunction.

Total recalls933since 2012

Last 12 months154reported

Class I364% of total

Ongoing480latest 21 Oct 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 25

Severity split

Class I 36 4%Class II 876 94%Class III 20 2%Other/pending 1

Why medical software is recalled

Companies

By year

202613715%
202513314%
202410611%
2023435%
2022465%
2021485%
2020566%
2019455%
2018505%
2017505%

Ongoing medical software recalls

480 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Device Malfunction	CA
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide

All medical software recalls, newest first

933 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Device Malfunction	CA
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Tandem t:slim mobile application t:slim Mobile Application, iOS recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Blue Seal SE and Blue Seal XE recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	SmartPath to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	MR 5300; Model number (REF): 1. 782110, 2. 782152 recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	EnCor EnCompass Breast Biopsy and Tissue Removal System Console recalled	Bard Peripheral Vascular	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade dStream recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Philips Medical Systems Technologies Ltd recalled	Philips North America	Device Malfunction	MA
7 Oct 2026Device	CLASS II	Evolution upgrade 1.5T amd Evolution upgrade 3.0T recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia 1.5T, 1.5T CX, and 1.5T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recalled	Spectrum Medical	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	MR 7700; Model number (REF): 1. 782120, 2. 782153 recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recalled	Spectrum Medical	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Ingenia 3.0T and 3.0T CX recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
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

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.