Patient Monitors recalls

1,014 medical device recalls in the patient monitors category are on file with the FDA, from 2012 to 30 Sep 2026. The leading reason is device malfunction.

Total recalls1,014since 2012

Last 12 months63reported

Class I646% of total

Ongoing283latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

2Nov '24 9 8 9Feb 3 9 3May 0 5 2Aug 1 2 6Nov 11 14 5Feb 1 1 2May 8 5 2Aug 7 0

Severity split

Class I 64 6%Class II 897 88%Class III 53 5%

Why patient monitors is recalled

Companies

By year

2026454%
2025596%
2024515%
2023929%
2022263%
2021495%
2020545%
2019737%
2018767%
2017646%

Ongoing patient monitors recalls

283 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	nGenuity Patient Monitor with Capnography recalled	Criticare Technologies	Device Malfunction	Nationwide
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	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	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
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide

All patient monitors recalls, newest first

1,014 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	nGenuity Patient Monitor with Capnography recalled	Criticare Technologies	Device Malfunction	Nationwide
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	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	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
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Digital ECG HD+12, HD+15 recalled by Midmark	Midmark	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Xhibit Central Station recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	GE Healthcare Portrait Core Services SW recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
8 Jul 2026Device	CLASS II	Radius VSM ECG pre-connected Set recalled by Masimo	Masimo	Device Malfunction	Nationwide
1 Jul 2026Device	CLASS II	Philips Telemetry Monitor 5500 1.4 GHz recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
1 Jul 2026Device	CLASS II	Philips Avalon Fetal Monitor, FM 30 Part numberM2703A recalled	Philips North America	Other	Nationwide
1 Jul 2026Device	CLASS II	Philips Avalon Fetal Monitor, FM20 recalled by Philips North America	Philips North America	Other	Nationwide
24 Jun 2026Device	CLASS II	HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	49 states
3 Jun 2026Device	CLASS II	GE HealthCare Carescape Telemetry Server V5 Ato recalled	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026Device	CLASS II	GE HealthCare Apexpro v5.0 - ARK2250 recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026Device	CLASS II	GE HealthCare Iou Assy ARK2250 Carescape Telemetry Server recalled	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026Device	CLASS II	GE HealthCare Carescape Telemetry Server Ark- - North America recalled	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026Device	CLASS II	GE HealthCare ApexPro v6.0 eDelivery recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026Device	CLASS II	GE HealthCare Trade IN Carescape Telemetry Server Ark recalled	GE Medical Systems Information Technologies	Device Malfunction	WI
13 May 2026Device	CLASS II	Spacelabs Ultraview SL Command Module SL Command Module recalled	Spacelabs Healthcare	Packaging Defects	Nationwide
6 May 2026Device	CLASS II	Genius" Review Station Display (Barco Monitor) recalled by Hologic	Hologic	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Medical Arterial Pressure Monitoring Tray, Reference recalled	Cook	Other	IN
18 Mar 2026Device	CLASS II	HealthCast "Vital Sync" Remote Patient Monitoring System recalled	Covidien	Device Malfunction	Nationwide
18 Feb 2026Device	CLASS III	Surepulse VS Cap Extra Large recalled by Surepulse Medical	Surepulse Medical	Other	Nationwide
18 Feb 2026Device	CLASS III	Surepulse VS Cap Extra Small recalled by Surepulse Medical	Surepulse Medical	Other	Nationwide
18 Feb 2026Device	CLASS III	Surepulse VS Cap Small recalled by Surepulse Medical	Surepulse Medical	Other	Nationwide
18 Feb 2026Device	CLASS III	Surepulse VS Cap Medium recalled by Surepulse Medical	Surepulse Medical	Other	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.