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AMSCO V-PRO
Model maX · Steris Mexico, S. de R.L. de C.V. · DI 00724995151997
MLR — Sterilizer, Chemical · Class II · 21 CFR 880.6860
UDILibrary device dossier · generated 2026-09-13 · 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
2018-07-26
Z-2959-2018
Class II
Terminated
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
code info di
Adverse-event reports — MAUDE (4)
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: 4
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
3
2019-02
0
2.83
2019-03
0
3
2019-04
0
2
2019-05
0
1.4
2019-06
0
1.4
2019-07
0
3.67
2019-08
0
3
2019-09
0
2.4
2019-10
0
3.8
2019-11
0
3
2019-12
0
4.33
2020-01
0
2.17
2020-02
0
4
2020-03
0
1.71
2020-04
0
3.14
2020-05
0
1.8
2020-06
0
3
2020-07
0
2.29
2020-08
0
2
2020-09
0
2.5
2020-10
0
2.33
2020-11
0
2.5
2020-12
0
1.6
2021-01
0
2.33
2021-02
0
3.5
2021-03
0
2.43
2021-04
0
4.5
2021-05
0
2
2021-06
0
2
2021-07
0
2.83
2021-08
0
2.08
2021-09
0
2.8
2021-10
0
2.13
2021-11
0
2.13
2021-12
0
2.57
2022-01
0
2.5
2022-02
0
1.17
2022-03
0
3
2022-04
0
2.4
2022-05
0
2.88
2022-06
0
1.83
2022-07
0
2.67
2022-08
0
2
2022-09
0
1.86
2022-10
0
1.63
2022-11
0
1.88
2022-12
0
3.17
2023-01
0
2
2023-02
0
1.73
2023-03
0
1.78
2023-04
0
2.5
2023-05
0
2.8
2023-06
0
1.92
2023-07
0
2.3
2023-08
0
2.4
2023-09
0
1.56
2023-11
0
1.5
2023-12
0
2.75
2024-01
0
1.33
2024-03
0
1.25
2024-04
0
1
2024-05
0
1.5
2024-06
0
2
2024-08
0
3.67
2024-09
0
4.75
2024-10
0
2.5
2024-11
0
1.7
2024-12
0
1.25
2025-01
0
1.6
2025-02
0
1.67
2025-03
0
2
2025-04
0
2.75
2025-05
2
1.75
2025-06
0
4.6
2025-07
0
5
2025-08
0
3.33
2025-09
0
2.67
2025-10
0
2.33
2025-11
0
3
2025-12
0
1.71
2026-01
0
3.4
2026-02
0
5
2026-03
0
2.5
2026-04
0
2
2026-05
2
2
2026-06
0
2.8
This device (reports/month)Average device in MLR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Steris Mexico, S. de R.L. de C.V.