Device Malfunction recalls

6,250 recalls have been issued for device malfunction, from 2012 to 9 Sep 2026. 641 of them came in the last 12 months. 597 were classified Class I.

Total recalls6,250since 2012

Last 12 months641reported

Class I59710% of total

Ongoing2,458latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

40Oct '24 22 43 52Jan '25 33 18 52Apr 14 54 34Jul 60 39 73Oct 29 59 36Jan '26 71 52 91Apr 26 77 49Jul 50 21

Severity split

Class I 597 10%Class II 5,544 89%Class III 108 2%Other/pending 1

Why device malfunction is recalled

Device Malfunction6,250100%

Companies

Siemens Medical Solutions USA3536%
Philips North America1913%
GE Healthcare1743%
Boston Scientific1322%
Siemens Healthcare Diagnostics1292%
Philips Medical Systems (Cleveland)1262%
Arrow International1202%
Baxter Healthcare1142%

Product types

By year

20264738%
20255178%
20245399%
20233516%
20223375%
20213826%
20204657%
20193926%
201865410%
20172714%

Ongoing device malfunction recalls

2,458 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	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 Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide

All device malfunction recalls, newest first

6,250 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	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 Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Velys Enabling Tech Robotic-Assist Station recalled	Medos International Sarl	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	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.