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StrykeFlow
Model 0250070520 · STRYKER CORPORATION · DI 07613327061369
GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered · Class II · 21 CFR 880.6740
UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2025-06-18
Z-2171-2025
Class II
Open, Classified
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
code info di
2017-11-17
Z-0835-2018
Class II
Terminated
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
code info di
Adverse-event reports — MAUDE (271)
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: 268 · Injury: 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
2
1.5
2019-02
4
4
2019-03
0
3
2019-04
1
1
2019-05
4
2
2019-06
1
1.38
2019-07
0
1
2019-08
2
1.5
2019-09
0
1.5
2019-10
1
2.2
2019-11
1
1.8
2019-12
0
1.57
2020-01
0
3
2020-02
0
1
2020-03
2
2
2020-04
0
1
2020-06
0
1
2020-07
8
3.5
2020-08
0
1.67
2020-09
3
2.33
2020-10
0
2.5
2020-11
2
2.4
2020-12
1
1.25
2021-01
0
1
2021-02
0
3
2021-03
0
2.33
2021-04
8
3.5
2021-05
0
3
2021-06
3
2
2021-07
3
2.67
2021-08
1
1
2021-09
0
1.33
2021-10
0
2
2021-11
1
2.4
2021-12
2
1.25
2022-01
0
1
2022-02
0
1
2022-03
2
1.2
2022-04
3
3.2
2022-05
2
1.75
2022-06
0
1.5
2022-07
1
1
2022-08
1
1
2022-09
1
1.6
2022-10
0
1.4
2022-11
1
1.57
2022-12
1
1
2023-01
0
1
2023-02
7
2.5
2023-03
1
1
2023-04
1
1.25
2023-05
0
1.4
2023-06
2
1.33
2023-07
1
1.33
2023-08
2
1.5
2023-10
0
1.57
2023-11
0
1
2023-12
0
1
2024-01
3
2.17
2024-02
7
5
2024-03
2
1.2
2024-04
0
1.5
2024-05
0
1
2024-06
1
1.8
2024-07
1
1
2024-09
5
2.33
2024-10
1
1.5
2024-11
3
2.33
2024-12
0
1
2025-01
0
1.25
2025-02
5
2.4
2025-03
30
6
2025-04
41
7
2025-05
22
7.14
2025-06
23
10
2025-07
3
2.6
2025-08
17
5
2025-09
5
2.4
2025-10
3
4.17
2025-11
3
4
2025-12
3
3.2
2026-01
0
1
2026-02
3
3.5
2026-03
4
2.33
2026-04
3
2.5
2026-05
0
7.5
2026-06
7
3
This device (reports/month)Average device in GCX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — STRYKER CORPORATION
Warning Letter 2017-04-06 Entellus Medical Inc.
Warning Letter 2015-04-08 Thermedx LLC
Injunction 2013-11-26 Physio-Control, Inc.
Warning Letter 2013-03-06 Stryker Corporation
Warning Letter 2013-03-06 Stryker Corporation
NAI 2026-06-18 International Life Sciences · 0 citations
VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
NAI 2025-05-22 Stryker Macroom · 0 citations
VAI 2025-03-27 Stryker GmbH · 1 citations
VAI 2025-03-27 Stryker GmbH · 1 citations
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VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
NAI 2024-11-13 POM Medical LLC · 0 citations
VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
NAI 2024-04-18 Physio-Control, Inc. · 0 citations
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