MICROTEK · 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.

16 linked reportsMalfunction 16

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
2019-05	0	1.2
2019-06	0	2
2019-07	0	1
2019-09	0	1
2019-10	0	1
2019-11	0	2
2019-12	0	1.33
2020-01	0	3
2020-02	0	4
2020-07	0	1
2020-10	0	1.5
2020-11	0	1
2020-12	0	2
2021-01	0	1.67
2021-02	0	3.5
2021-03	0	1
2021-05	0	1.5
2021-06	0	2
2021-08	0	3
2021-09	0	1
2021-10	0	1
2021-11	0	1
2021-12	0	2
2022-02	0	1
2022-03	0	1
2022-04	0	1.5
2022-05	13	4.5
2022-06	3	1.67
2022-07	0	1
2022-08	0	1.33
2022-09	0	1.6
2022-10	0	1
2022-11	0	1
2022-12	0	1
2023-01	0	1
2023-02	0	1
2023-03	0	1
2023-04	0	2
2023-05	0	1.67
2023-06	0	1.75
2023-07	0	8
2023-08	0	1
2023-09	0	1
2023-10	0	1.25
2023-11	0	2
2023-12	0	1
2024-03	0	1
2024-04	0	1
2024-05	0	1.33
2024-06	0	1.5
2024-07	0	1.25
2024-08	0	1
2024-10	0	1
2024-12	0	1.25
2025-01	0	1.33
2025-02	0	1
2025-03	0	2
2025-04	0	1
2025-05	0	1
2025-06	0	2
2025-08	0	1
2025-09	0	1
2025-10	0	2
2025-12	0	1
2026-01	0	1.67
2026-02	0	1.33
2026-03	0	1
2026-04	0	1.25
2026-05	0	1.4

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2022-06-03	8043817-2022-00021	Malfunction	Available	exact di
2022-06-02	8043817-2022-00020	Malfunction	Available	exact di
2022-06-02	8043817-2022-00019	Malfunction	Available	exact di
2022-05-31	8043817-2022-00017	Malfunction	Available	exact di
2022-05-31	8043817-2022-00015	Malfunction	Available	exact di
2022-05-31	8043817-2022-00016	Malfunction	Available	exact di
2022-05-31	8043817-2022-00018	Malfunction	Available	exact di
2022-05-20	8043817-2022-00008	Malfunction	Available	exact di
2022-05-20	8043817-2022-00011	Malfunction	Available	exact di
2022-05-20	8043817-2022-00009	Malfunction	Available	exact di
2022-05-20	8043817-2022-00014	Malfunction	Available	exact di
2022-05-20	8043817-2022-00010	Malfunction	Available	exact di
2022-05-20	8043817-2022-00012	Malfunction	Available	exact di
2022-05-20	8043817-2022-00013	Malfunction	Available	exact di
2022-05-19	8043817-2022-00007	Malfunction	Available	exact di

Showing 1–15 of 16

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-04-22	NAI	No action indicated	MICROTEK MEDICAL LLC	0
2018-06-15	NAI	No action indicated	MICROTEK MEDICAL LLC	0
2016-08-03	VAI	Voluntary action indicated	Microtek Medical Inc	4
2011-06-22	NAI	No action indicated	Microtek Medical Inc	0

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