Needle · 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 Unionjoimax® Needle 18G, Quincke, graduatedB-04250337103370
European Unionjoimax® Needle 18G, Quincke, graduated42503371ACNENEE7V

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 reportsInjury 1Malfunction 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
2019-02	0	2.6
2019-03	0	2.5
2019-04	0	5.6
2019-05	0	2.75
2019-06	0	3.5
2019-07	0	3
2019-08	0	5.67
2019-09	0	2.5
2019-10	0	5
2019-11	0	4.4
2019-12	0	3.2
2020-01	0	5
2020-02	0	4
2020-03	0	4.75
2020-04	0	2
2020-05	0	2.25
2020-06	0	1
2020-07	0	1.33
2020-08	0	1.67
2020-09	0	1.67
2020-10	0	1.8
2020-11	0	1.67
2020-12	0	1.5
2021-01	0	1.5
2021-02	0	2.8
2021-03	0	1.83
2021-04	0	1.67
2021-05	0	2.5
2021-06	0	4
2021-07	0	1.4
2021-08	0	2.5
2021-09	0	1.67
2021-10	0	1.8
2021-11	0	2
2021-12	0	1.6
2022-01	0	2.25
2022-02	0	1.67
2022-03	0	4
2022-04	0	2.25
2022-05	0	1
2022-06	0	1.67
2022-07	0	1.33
2022-08	0	4
2022-09	0	3
2022-10	0	2
2022-11	0	1.5
2022-12	0	2.67
2023-01	0	4
2023-02	0	3.33
2023-03	0	2.17
2023-04	0	2.8
2023-05	0	2
2023-06	0	1
2023-07	0	3.33
2023-08	0	2.2
2023-09	0	1.6
2023-10	0	2.6
2023-11	0	1.83
2023-12	0	2.75
2024-01	0	2.25
2024-02	0	3
2024-03	0	2.33
2024-04	0	2.29
2024-05	0	3.33
2024-06	0	3.33
2024-07	0	3.75
2024-08	0	1.8
2024-09	0	2.6
2024-10	0	4.5
2024-11	2	3.5
2024-12	0	6.6
2025-01	0	5.5
2025-02	0	10.5
2025-03	0	4.4
2025-04	0	7.33
2025-05	0	6.5
2025-06	0	9.2
2025-07	0	4.5
2025-08	0	2.67
2025-09	0	2.5
2025-10	0	2
2025-11	0	3
2025-12	0	4.25
2026-01	0	1.67
2026-02	0	2.2
2026-03	0	2
2026-04	0	7
2026-05	0	2
2026-06	0	8.43

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

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2018-07-04	VAI	Voluntary action indicated	Joimax GmbH	0
2018-07-04	VAI	Voluntary action indicated	Joimax GmbH	0

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