Auris Health recalls

Auris Health has 8 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 25 Feb 2026. 7 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls8since 2019

Last 12 months2reported

Class I00% of total

Ongoing7latest 25 Feb 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 1Nov 0 0 1Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 8 100%Class III 0 0%

Why auris health is recalled

Device Malfunction788%
Packaging Defects113%

Product types

By year

2026113%
2025113%
2024225%
2023338%
2019113%

Ongoing auris health recalls

7 active

Reported	Class	Recall	Company	Reason	Where
25 Feb 2026Device	CLASS II	Monarch Platform, Bronchoscopy recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	Monarch Bronchoscope recalled by Auris Health	Auris Health	Packaging Defects	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Urology) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Endoscopy) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
13 Dec 2023Device	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states
13 Dec 2023Device	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states

All auris health recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
25 Feb 2026Device	CLASS II	Monarch Platform, Bronchoscopy recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	Monarch Bronchoscope recalled by Auris Health	Auris Health	Packaging Defects	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Urology) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Endoscopy) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
13 Dec 2023Device	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states
13 Dec 2023Device	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states
13 Dec 2023Device	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states
27 Nov 2019Device	CLASS II	Monarch, Aspirating Biopsy Needle recalled by Auris Health	Auris Health	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.