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Ambu® SPUR® II Adult Resuscitator
Model 523611051 · Ambu A/S · DI 05707480149513
OEV — Cardiopulmonary Resuscitation Aid Kit · Class II · 21 CFR 868.5915
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
2025-07-09
Z-2181-2025
Class I
Open, Classified
Potential for the manometer port being blocked rendering the manometer non-functional.
code info di
Adverse-event reports — MAUDE (6)
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.
Injury: 3 · Malfunction: 3
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
2020-03
0
1
2020-04
0
2.5
2020-05
0
1
2020-06
0
1
2020-07
0
1
2020-10
0
1
2020-11
0
1
2020-12
0
1
2021-01
0
1
2021-05
0
1
2021-08
0
1
2021-09
0
1
2021-11
0
1
2022-01
0
3
2022-06
0
1
2023-02
0
1
2023-04
0
1
2023-05
0
1
2023-08
0
1
2023-11
0
4
2024-01
0
1
2024-04
0
2
2024-05
0
1
2024-06
0
1.33
2024-07
0
4
2024-08
0
4
2024-11
6
6
2024-12
0
4
2025-01
0
3
2025-02
0
1
2025-04
0
4
2025-05
0
9.33
2025-06
0
24
2025-07
0
6
2025-08
0
1
2025-09
0
3
2025-10
0
3.5
2025-11
0
4
2026-01
0
3
2026-02
0
4
2026-04
0
5
2026-05
0
2
This device (reports/month)Average device in OEV (reports/device/month)