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StrykeFlow

Model 0250070500 · STRYKER CORPORATION · DI 07613327061390

GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500

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)

InitiatedRecall #ClassStatusReasonLink basis
2025-06-18Z-2170-2025Class IIOpen, ClassifiedDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.code info di
2017-11-17Z-0835-2018Class IITerminatedRoutine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.code info di

Adverse-event reports — MAUDE (360)

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: 356 · Injury: 2 · Other: 2

132638512019-01: 0 reports for this device; peer average 2.42/device2019-02: 11 reports for this device; peer average 3.53/device2019-03: 2 reports for this device; peer average 2.95/device2019-04: 1 reports for this device; peer average 3.13/device2019-05: 2 reports for this device; peer average 2.46/device2019-06: 2 reports for this device; peer average 3.58/device2019-07: 0 reports for this device; peer average 2.42/device2019-08: 1 reports for this device; peer average 2.47/device2019-09: 3 reports for this device; peer average 2.47/device2019-10: 0 reports for this device; peer average 2.71/device2019-11: 2 reports for this device; peer average 2.12/device2019-12: 3 reports for this device; peer average 2.35/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 3 reports for this device; peer average 2.7/device2020-03: 2 reports for this device; peer average 2.28/device2020-04: 0 reports for this device; peer average 2.54/device2020-05: 0 reports for this device; peer average 1.98/device2020-06: 1 reports for this device; peer average 2.78/device2020-07: 0 reports for this device; peer average 2.77/device2020-08: 3 reports for this device; peer average 4.33/device2020-09: 4 reports for this device; peer average 4.4/device2020-10: 0 reports for this device; peer average 3.99/device2020-11: 1 reports for this device; peer average 4.47/device2020-12: 2 reports for this device; peer average 3.87/device2021-01: 1 reports for this device; peer average 3.99/device2021-02: 0 reports for this device; peer average 3.89/device2021-03: 3 reports for this device; peer average 4.83/device2021-04: 3 reports for this device; peer average 4.7/device2021-05: 1 reports for this device; peer average 4.05/device2021-06: 2 reports for this device; peer average 4.28/device2021-07: 4 reports for this device; peer average 3.88/device2021-08: 8 reports for this device; peer average 3.87/device2021-09: 1 reports for this device; peer average 3.91/device2021-10: 2 reports for this device; peer average 3.99/device2021-11: 1 reports for this device; peer average 3.49/device2021-12: 2 reports for this device; peer average 4.46/device2022-01: 2 reports for this device; peer average 4.57/device2022-02: 3 reports for this device; peer average 5.03/device2022-03: 5 reports for this device; peer average 5.45/device2022-04: 3 reports for this device; peer average 6.48/device2022-05: 0 reports for this device; peer average 5.46/device2022-06: 2 reports for this device; peer average 6.07/device2022-07: 1 reports for this device; peer average 6.34/device2022-08: 5 reports for this device; peer average 6.38/device2022-09: 1 reports for this device; peer average 5.53/device2022-10: 6 reports for this device; peer average 5.35/device2022-11: 1 reports for this device; peer average 5.52/device2022-12: 0 reports for this device; peer average 6/device2023-01: 0 reports for this device; peer average 5.73/device2023-02: 1 reports for this device; peer average 4.87/device2023-03: 2 reports for this device; peer average 5.86/device2023-04: 3 reports for this device; peer average 5.47/device2023-05: 10 reports for this device; peer average 5.86/device2023-06: 2 reports for this device; peer average 7.1/device2023-07: 0 reports for this device; peer average 6.1/device2023-08: 3 reports for this device; peer average 6.28/device2023-09: 1 reports for this device; peer average 5.92/device2023-10: 0 reports for this device; peer average 6.38/device2023-11: 1 reports for this device; peer average 5.76/device2023-12: 0 reports for this device; peer average 6.05/device2024-01: 1 reports for this device; peer average 5.53/device2024-02: 0 reports for this device; peer average 6.18/device2024-03: 9 reports for this device; peer average 5.56/device2024-04: 4 reports for this device; peer average 6.32/device2024-05: 1 reports for this device; peer average 5.3/device2024-06: 2 reports for this device; peer average 7.07/device2024-07: 1 reports for this device; peer average 5.75/device2024-08: 5 reports for this device; peer average 6.5/device2024-09: 1 reports for this device; peer average 6.28/device2024-10: 6 reports for this device; peer average 7.11/device2024-11: 4 reports for this device; peer average 4.55/device2024-12: 2 reports for this device; peer average 4.77/device2025-01: 4 reports for this device; peer average 4.42/device2025-02: 2 reports for this device; peer average 4.03/device2025-03: 33 reports for this device; peer average 5.17/device2025-04: 51 reports for this device; peer average 4.67/device2025-05: 45 reports for this device; peer average 4.69/device2025-06: 18 reports for this device; peer average 4.58/device2025-07: 17 reports for this device; peer average 4.68/device2025-08: 6 reports for this device; peer average 5.45/device2025-09: 2 reports for this device; peer average 3.97/device2025-10: 1 reports for this device; peer average 4.59/device2025-11: 8 reports for this device; peer average 4.86/device2025-12: 4 reports for this device; peer average 6.15/device2026-01: 2 reports for this device; peer average 4.95/device2026-02: 6 reports for this device; peer average 5.05/device2026-03: 0 reports for this device; peer average 5.77/device2026-04: 1 reports for this device; peer average 6.2/device2026-05: 0 reports for this device; peer average 5.86/device2026-06: 1 reports for this device; peer average 5.01/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.42
2019-02113.53
2019-0322.95
2019-0413.13
2019-0522.46
2019-0623.58
2019-0702.42
2019-0812.47
2019-0932.47
2019-1002.71
2019-1122.12
2019-1232.35
2020-0102.55
2020-0232.7
2020-0322.28
2020-0402.54
2020-0501.98
2020-0612.78
2020-0702.77
2020-0834.33
2020-0944.4
2020-1003.99
2020-1114.47
2020-1223.87
2021-0113.99
2021-0203.89
2021-0334.83
2021-0434.7
2021-0514.05
2021-0624.28
2021-0743.88
2021-0883.87
2021-0913.91
2021-1023.99
2021-1113.49
2021-1224.46
2022-0124.57
2022-0235.03
2022-0355.45
2022-0436.48
2022-0505.46
2022-0626.07
2022-0716.34
2022-0856.38
2022-0915.53
2022-1065.35
2022-1115.52
2022-1206
2023-0105.73
2023-0214.87
2023-0325.86
2023-0435.47
2023-05105.86
2023-0627.1
2023-0706.1
2023-0836.28
2023-0915.92
2023-1006.38
2023-1115.76
2023-1206.05
2024-0115.53
2024-0206.18
2024-0395.56
2024-0446.32
2024-0515.3
2024-0627.07
2024-0715.75
2024-0856.5
2024-0916.28
2024-1067.11
2024-1144.55
2024-1224.77
2025-0144.42
2025-0224.03
2025-03335.17
2025-04514.67
2025-05454.69
2025-06184.58
2025-07174.68
2025-0865.45
2025-0923.97
2025-1014.59
2025-1184.86
2025-1246.15
2026-0124.95
2026-0265.05
2026-0305.77
2026-0416.2
2026-0505.86
2026-0615.01
This device (reports/month)Average device in GCJ (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
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • 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
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations