Patient Monitors recalls

1,022 medical device recalls in the patient monitors category are on file with the FDA, from 2012 to 14 Oct 2026. The leading reason is device malfunction.

Total recalls1,022since 2012

Last 12 months70reported

Class I646% of total

Ongoing291latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

9Dec '24 8 9 3Mar 9 3 0Jun 5 2 1Sep 2 6 11Dec 14 5 1Mar 1 2 8Jun 5 2 7Sep 8 0

Severity split

Class I 64 6%Class II 898 88%Class III 60 6%

Why patient monitors is recalled

Companies

By year

2026535%
2025596%
2024515%
2023929%
2022263%
2021495%
2020545%
2019737%
2018767%
2017646%

Ongoing patient monitors recalls

291 active

Reported	Class	Recall	Company	Reason	Where
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 III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	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 III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision N1 and N-Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide

All patient monitors recalls, newest first

1,022 total

Reported	Class	Recall	Company	Reason	Where
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 III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	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 III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
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	Nihon Kohden CNS-6200 Series Central Nurse Station recalled	Nihon Kohden America	Device Malfunction	Nationwide
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

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.