Jacobson Micro Needle Holder Flat Handle · 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	10
2019-02	0	10
2019-03	0	1
2019-04	0	7
2019-05	0	1
2019-06	0	3
2019-07	0	2
2019-08	0	10
2019-09	0	1.5
2019-10	0	1
2019-11	0	7
2019-12	0	2
2020-02	0	2
2020-03	0	3
2020-04	0	2
2020-05	0	2
2020-06	1	2
2020-07	0	3
2020-09	0	1
2020-10	0	1
2020-11	0	1
2020-12	0	3
2021-02	0	1
2021-04	0	3
2021-05	0	4
2021-07	0	1
2021-09	0	2
2022-01	0	1
2022-02	0	4
2022-03	0	1
2022-08	0	1
2022-09	0	3.5
2022-10	0	2
2022-12	0	1
2023-01	0	1
2023-02	0	3
2023-03	0	2
2023-04	0	3
2023-07	0	1.5
2023-10	0	2
2023-11	0	3
2023-12	0	2
2024-02	0	2
2024-03	0	3
2024-04	0	2
2024-05	0	6
2024-06	0	1
2024-07	0	7
2024-09	0	3
2024-10	0	6
2024-12	0	1
2025-01	0	2
2025-03	0	1
2025-04	0	4
2025-06	0	2
2025-07	0	4
2025-12	0	1
2026-01	0	1
2026-03	0	1
2026-04	0	1
2026-05	0	2

This device (reports/month)Average device in FHQ (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
2020-06-26	MW5095258	Malfunction	Available	catalog number

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2019-08-15	NAI	No action indicated	Scanlan International, Inc.
2019-08-15	NAI	No action indicated	Scanlan International, Inc.
2016-02-03	NAI	No action indicated	Scanlan International, Inc.
2016-02-03	NAI	No action indicated	Scanlan International, Inc.
2012-10-17	NAI	No action indicated	Scanlan International, Inc.
2012-10-17	NAI	No action indicated	Scanlan International, Inc.
2010-06-22	NAI	No action indicated	Scanlan International, Inc.
2010-06-22	NAI	No action indicated	Scanlan International, Inc.

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