Device Malfunction recalls

7,895 recalls have been issued for device malfunction, from 2012 to 21 Oct 2026. 833 of them came in the last 12 months. 722 were classified Class I.

Total recalls7,895since 2012

Last 12 months833reported

Class I7229% of total

Ongoing3,101latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

34Nov '24 50 80 35Feb 40 72 17May 77 50 72Aug 51 79 44Nov 77 46 84Feb 61 97 31May 89 54 55Aug 66 129

Severity split

Class I 722 9%Class II 7,034 89%Class III 137 2%Other/pending 2

Why device malfunction is recalled

Device Malfunction7,895100%

Companies

Siemens Medical Solutions USA3985%
Philips North America2483%
GE Healthcare1832%
Siemens Healthcare Diagnostics1482%
Boston Scientific1412%
Baxter Healthcare1372%
Philips Medical Systems (Cleveland)1372%
Arrow International1202%

Product types

Brands

By year

20267129%
20256949%
20246278%
20234245%
20223735%
20214716%
20206338%
20194876%
201884911%
20173504%

Ongoing device malfunction recalls

3,101 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Iomax Cortical Module recalled by Cadwell Industries	Cadwell Industries	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	IntelePACS, InteleConnect Portal/Tech Portal Versions recalled	Intelerad Medical Systems	Device Malfunction	Nationwide

All device malfunction recalls, newest first

7,895 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Iomax Cortical Module recalled by Cadwell Industries	Cadwell Industries	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	IntelePACS, InteleConnect Portal/Tech Portal Versions recalled	Intelerad Medical Systems	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Likorall Overhead Lifts Product Code: 3121001 Product Description recalled	Baxter Healthcare	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Williams Cystoscopic Injection Needles, used recalled by Cook	Cook	Device Malfunction	5 states
14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	T1 Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Intellijoint Navigation System: Workstation G2 Configured recalled	Intellijoint Surgical	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Presource Packs containing Medtronic Microstream Components recalled	Cardinal Health 200	Device Malfunction	IL
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	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 III	BeneVision N1 and N-Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	ePM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	HexaVue Focus Integration System, a single recalled by Steris	Steris	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Nihon Kohden CNS-6200 Series Central Nurse Station recalled	Nihon Kohden America	Device Malfunction	Nationwide
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	Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled	ASP Global	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.