AVANOS · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

1 linked reportMalfunction 1

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1
2019-03	0	2
2019-04	0	1.4
2019-05	0	2.63
2019-06	0	3
2019-07	0	4.33
2019-08	0	10.2
2019-09	0	1.33
2019-10	0	5.25
2019-11	0	8.67
2019-12	0	1.25
2020-02	0	2
2020-03	0	4
2020-05	0	2
2020-07	0	1.5
2020-08	0	3
2020-09	0	1.8
2020-10	0	1.5
2020-11	0	1
2020-12	0	3.33
2021-01	0	1.33
2021-02	0	1.5
2021-04	0	3
2021-05	0	1.25
2021-06	0	1.43
2021-07	0	2
2021-08	0	1
2021-09	0	2
2021-10	0	1.5
2021-11	0	3
2022-01	0	1.5
2022-02	0	2
2022-03	0	2
2022-04	0	2
2022-05	0	2
2022-06	0	10
2022-07	0	1.5
2022-09	0	5.5
2022-10	0	2
2022-11	0	1.67
2022-12	0	1.6
2023-02	0	2
2023-03	0	1.25
2023-04	0	2
2023-05	0	2
2023-06	0	2
2023-07	0	2
2023-08	0	2
2023-09	0	4
2023-10	0	1.8
2023-11	0	1.25
2023-12	0	1.5
2024-01	0	2.25
2024-02	0	1.67
2024-03	0	2.25
2024-04	0	2
2024-05	0	2
2024-06	1	1
2024-07	0	2.5
2024-08	0	4
2024-09	0	1.5
2024-10	0	2.25
2024-12	0	1.67
2025-01	0	2
2025-02	0	3.75
2025-03	0	5
2025-04	0	3
2025-05	0	3
2025-06	0	3.5
2025-07	0	1.75
2025-08	0	4.4
2025-09	0	2
2025-10	0	1.4
2025-11	0	3.33
2025-12	0	2.4
2026-01	0	3
2026-02	0	1.83
2026-03	0	1.89
2026-04	0	3
2026-05	0	1.56
2026-06	0	3.17

This device (reports/month)Average device in GXI (reports/device/month)

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-06-20	19573960	Malfunction	Available	model number

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-12-15	VAI	Voluntary action indicated	Avanos Medical, Inc.	3
2023-12-15	VAI	Voluntary action indicated	Avanos Medical, Inc.	3
2018-10-02	VAI	Voluntary action indicated	Avanos Medical, Inc.	1
2018-10-02	VAI	Voluntary action indicated	Avanos Medical, Inc.	1
2016-07-29	VAI	Voluntary action indicated	Avanos Medical, Inc.	1
2016-07-29	VAI	Voluntary action indicated	Avanos Medical, Inc.	1
2014-11-05	NAI	No action indicated	Avanos Medical, Inc.	0
2014-11-05	NAI	No action indicated	Avanos Medical, Inc.	0
2014-03-07	VAI	Voluntary action indicated	Avanos Medical, Inc.	4
2014-03-07	VAI	Voluntary action indicated	Avanos Medical, Inc.	4
2013-12-10	NAI	No action indicated	Avanos Medical, Inc.	0
2013-12-10	NAI	No action indicated	Avanos Medical, Inc.	0
2013-04-10	WL	Warning Letter	Avanos Medical, Inc.	—
2013-04-10	WL	Warning Letter	Avanos Medical, Inc.	—
2013-01-04	OAI	Official action indicated	Avanos Medical, Inc.	6
2013-01-04	OAI	Official action indicated	Avanos Medical, Inc.	6
2012-10-31	OAI	Official action indicated	Avanos Medical, Inc.	10
2012-10-31	OAI	Official action indicated	Avanos Medical, Inc.	10
2011-07-08	VAI	Voluntary action indicated	Avanos Medical, Inc.	8
2011-07-08	VAI	Voluntary action indicated	Avanos Medical, Inc.	8
2010-11-19	OAI	Official action indicated	Avanos Medical, Inc.	4
2010-11-19	OAI	Official action indicated	Avanos Medical, Inc.	4
2008-12-22	WL	Warning Letter	Avanos Medical, Inc.	—
2008-12-22	WL	Warning Letter	Avanos Medical, Inc.	—

Similar devices