Device Malfunction recalls

7,766 recalls have been issued for device malfunction, from 2012 to 30 Sep 2026. 762 of them came in the last 12 months. 721 were classified Class I.

Total recalls7,766since 2012

Last 12 months762reported

Class I7219% of total

Ongoing2,972latest 30 Sep 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 0

Severity split

Class I 721 9%Class II 6,916 89%Class III 128 2%Other/pending 1

Why device malfunction is recalled

Device Malfunction7,766100%

Companies

Siemens Medical Solutions USA3985%
Philips North America2353%
GE Healthcare1832%
Siemens Healthcare Diagnostics1482%
Boston Scientific1412%
Philips Medical Systems (Cleveland)1372%
Baxter Healthcare1362%
Arrow International1202%

Product types

Brands

BMC10%
McKesson10%

By year

20265838%
20256949%
20246278%
20234245%
20223735%
20214716%
20206338%
20194876%
201884911%
20173505%

Ongoing device malfunction recalls

2,972 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion 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
30 Sep 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Ingenia 3.0T and Ingenia 3.0T CX recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

All device malfunction recalls, newest first

7,766 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion 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
30 Sep 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Ingenia 3.0T and Ingenia 3.0T CX recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Evolution upgrade 1.5T and Evolution upgrade 3.0T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva XR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	MR 5300 Model Number (REF): 1. recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	MR 7700 and Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	nGenuity Patient Monitor with Capnography recalled	Criticare Technologies	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	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	Philips Patient Information Center iX recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	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 I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	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 I	Impella Optical Controller with the below product recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	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.