SCANLAN® · recalls, adverse events, clearances

Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

European UnionB-00846159040708B-00846159040708

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 reportInjury 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	2.2
2019-02	0	5.33
2019-03	0	2.33
2019-04	0	1.67
2019-05	0	5
2019-06	0	2.5
2019-07	0	1.67
2019-08	0	2.33
2019-09	0	2.25
2019-10	0	1.73
2019-11	0	2
2019-12	0	1.67
2020-01	0	2.6
2020-02	0	1.33
2020-03	0	2
2020-05	0	4
2020-06	0	2.5
2020-07	0	3.8
2020-08	0	1.67
2020-09	0	2.33
2020-10	0	5
2020-11	0	6.33
2020-12	0	4.75
2021-01	0	1
2021-02	0	1.67
2021-03	0	4.13
2021-04	0	5.33
2021-05	0	3
2021-06	0	1.29
2021-07	0	12
2021-08	0	2.67
2021-09	0	5
2021-10	0	2.25
2021-11	0	4.33
2021-12	0	1.75
2022-01	0	2
2022-02	0	1.67
2022-03	0	6.43
2022-04	0	3.67
2022-05	0	4.67
2022-06	0	2.17
2022-07	0	2.8
2022-08	0	10.5
2022-09	0	6.67
2022-10	0	2.4
2022-11	0	2.33
2022-12	0	2.33
2023-01	0	3
2023-02	0	2.43
2023-03	0	2.5
2023-04	0	2
2023-05	0	7.5
2023-06	0	3.5
2023-07	0	6.6
2023-08	0	2.25
2023-09	0	3
2023-10	0	5.8
2023-11	0	4.33
2023-12	0	5.2
2024-01	0	1.89
2024-02	0	3.57
2024-03	0	2.5
2024-04	0	3.29
2024-05	0	3.8
2024-06	0	3
2024-07	0	2.07
2024-08	0	2.86
2024-09	0	4.5
2024-10	0	3.33
2024-11	1	2.71
2024-12	0	2.5
2025-01	0	3.33
2025-02	0	4.14
2025-03	0	2.2
2025-04	0	6
2025-05	0	2.67
2025-06	0	4.14
2025-07	0	2
2025-08	0	3.88
2025-09	0	2.67
2025-10	0	6.75
2025-11	0	2.25
2025-12	0	4.5
2026-01	0	2.5
2026-02	0	2.11
2026-03	0	2.75
2026-04	0	3.5
2026-05	0	2.56
2026-06	0	4.86

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

Recall history

No recalls linked.

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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