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aScope™ 5 Broncho HD 5.6/2.8 Sampler Set
Model 622002000US · Ambu A/S · DI 05707480156542
EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2025-04-07
Z-1723-2025
Class II
Open, Classified
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
code info di
Adverse-event reports — MAUDE (24)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 24
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
1.2
2019-02
0
1.5
2019-03
0
6.89
2019-04
0
44.75
2019-05
0
4
2019-06
0
3
2019-07
0
2.54
2019-08
0
4.78
2019-09
0
2.78
2019-10
0
2.57
2019-11
0
2.4
2019-12
0
4.25
2020-01
0
2.92
2020-02
0
6.2
2020-03
0
2.33
2020-04
0
4.31
2020-05
0
2.93
2020-06
0
4.24
2020-07
0
4.65
2020-08
0
4.5
2020-09
0
3.76
2020-10
0
3.91
2020-11
0
4.52
2020-12
0
6.57
2021-01
0
4.39
2021-02
0
4.04
2021-03
0
5.57
2021-04
0
4.75
2021-05
0
5.1
2021-06
0
4.02
2021-07
0
3.22
2021-08
0
4.9
2021-09
0
4.18
2021-10
0
4.75
2021-11
0
3.93
2021-12
0
4.87
2022-01
0
4.98
2022-02
0
4.54
2022-03
0
6.65
2022-04
0
6.56
2022-05
0
5.72
2022-06
0
6.05
2022-07
0
6.22
2022-08
0
5.78
2022-09
0
5.19
2022-10
0
5.56
2022-11
0
5.65
2022-12
0
5.77
2023-01
0
8
2023-02
0
5.67
2023-03
0
7.22
2023-04
0
5.99
2023-05
0
6.6
2023-06
0
6.31
2023-07
0
6.17
2023-08
0
7.54
2023-09
0
6.8
2023-10
0
6.71
2023-11
0
7.17
2023-12
0
7.04
2024-01
0
6.36
2024-02
0
6.05
2024-03
0
7.21
2024-04
0
6.19
2024-05
0
6.2
2024-06
0
7.13
2024-07
0
6.06
2024-08
0
7.7
2024-09
3
6.97
2024-10
0
8.15
2024-11
0
10.86
2024-12
0
4.17
2025-01
0
4.16
2025-02
0
3.73
2025-03
3
4.21
2025-04
13
4.31
2025-05
0
4.93
2025-06
3
4.86
2025-07
0
5.79
2025-08
0
5.13
2025-09
0
4.38
2025-10
0
5.19
2025-11
0
6.62
2025-12
0
10.31
2026-01
0
8.47
2026-02
0
6.48
2026-03
0
6.61
2026-04
0
8.85
2026-05
2
9.34
2026-06
0
8.3
This device (reports/month)Average device in EOQ (reports/device/month)