Patient Monitors recalls

1,012 medical device recalls in the patient monitors category are on file with the FDA, from 2012 to 9 Sep 2026. The leading reason is device malfunction.

Total recalls1,012since 2012

Last 12 months62reported

Class I636% of total

Ongoing281latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

14Oct '24 2 9 8Jan '25 9 3 9Apr 3 0 5Jul 2 1 2Oct 6 11 14Jan '26 5 1 1Apr 2 8 5Jul 2 5

Severity split

Class I 63 6%Class II 896 89%Class III 53 5%

Why patient monitors is recalled

Companies

By year

2026434%
2025596%
2024515%
2023929%
2022263%
2021495%
2020545%
2019737%
2018768%
2017646%

Ongoing patient monitors recalls

281 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	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

All patient monitors recalls, newest first

1,012 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	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 V 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 4 GHz recalled by Philips North America	Philips North America	Lead & Heavy Metals	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.