3M Company dba 3M Health Care · 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.

2 linked reportsMalfunction 2

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-02	0	1
2019-04	0	1.25
2019-05	0	1
2019-06	0	1
2019-07	0	2
2019-08	0	1
2019-10	0	1.5
2019-12	0	1.25
2020-01	0	1
2020-02	0	1
2020-04	0	1
2020-07	0	1
2020-08	0	1.33
2020-09	0	1
2020-10	0	1
2020-11	0	2.33
2020-12	0	1
2021-01	0	2
2021-02	0	1
2021-03	0	1.33
2021-04	0	2
2021-05	0	2
2021-06	0	1
2021-07	0	2
2021-08	0	1
2021-09	0	1
2021-10	0	2.75
2021-11	0	1.5
2021-12	0	3
2022-02	0	2
2022-03	0	1.5
2022-05	0	2
2022-07	0	1.5
2022-08	0	1.67
2022-09	0	1.43
2022-10	0	1.5
2022-11	0	3.8
2022-12	0	2
2023-01	0	1.8
2023-02	0	2.57
2023-03	0	4
2023-04	0	2.5
2023-05	0	1.36
2023-06	0	2.8
2023-07	0	1.25
2023-08	0	2.17
2023-09	0	3
2023-10	0	1.17
2023-11	0	1.5
2023-12	0	2
2024-01	0	1.2
2024-02	0	2.8
2024-03	0	2.83
2024-04	0	1
2024-05	0	1.67
2024-06	0	1.67
2024-07	0	2
2024-08	0	2
2024-09	0	1.71
2024-11	0	2
2025-01	0	5
2025-02	0	2.5
2025-03	0	1.75
2025-04	0	2
2025-05	0	3
2025-06	0	3
2025-07	0	4.75
2025-08	0	4
2025-09	2	5.33
2025-10	0	9.25
2025-11	0	9
2025-12	0	8
2026-01	0	12
2026-02	0	4.14
2026-03	0	5.5
2026-04	0	4.4
2026-05	0	5.2
2026-06	0	6

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

Failure-mode summaryAI-generated

2 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-09-15	23050818	Malfunction	Available	catalog number

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2026-06-24	NAI	No action indicated	3m Company	0
2026-06-24	NAI	No action indicated	3m Company	0
2019-04-17	VAI	Voluntary action indicated	3M	4
2017-11-27	NAI	No action indicated	3M Company	0
2016-12-08	NAI	No action indicated	3M Company	0
2016-12-08	NAI	No action indicated	3M Company	0
2016-12-06	NAI	No action indicated	3M Company	0
2016-09-14	NAI	No action indicated	3M Company	0
2015-11-06	VAI	Voluntary action indicated	3M Company	1
2015-03-19	OAI	Official action indicated	3m Canada Company	5
2014-07-09	NAI	No action indicated	3M Co	0
2014-07-09	NAI	No action indicated	3M Co	0
2014-06-26	NAI	No action indicated	3M Company	0
2014-06-26	NAI	No action indicated	3M Company	0
2014-04-25	NAI	No action indicated	3M Company	0
2013-12-13	NAI	No action indicated	3M Company	0
2013-08-16	NAI	No action indicated	3m Company	0
2013-08-16	NAI	No action indicated	3m Company	0
2013-03-28	NAI	No action indicated	3M Company	1
2012-12-05	NAI	No action indicated	3M COMPANY	0
2010-06-07	WL	Warning Letter	3M Company	—

Similar devices