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Neptune

Model 0703047000 · STRYKER CORPORATION · DI 07613327117202

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

UDILibrary device dossier · generated 2026-09-07 · 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
2024-10-04Z-0365-2025Class IIOpen, ClassifiedThere is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuriescode info di
2024-10-04Z-0368-2025Class IIOpen, ClassifiedThere is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuriescode info di

Adverse-event reports — MAUDE (132)

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: 121 · Injury: 11

4711142019-01: 1 reports for this device; peer average 6.86/device2019-02: 0 reports for this device; peer average 4.35/device2019-03: 1 reports for this device; peer average 4.42/device2019-04: 0 reports for this device; peer average 6.12/device2019-05: 0 reports for this device; peer average 4.8/device2019-06: 0 reports for this device; peer average 5.04/device2019-07: 1 reports for this device; peer average 5.86/device2019-08: 1 reports for this device; peer average 6.1/device2019-09: 1 reports for this device; peer average 4.99/device2019-10: 0 reports for this device; peer average 5.85/device2019-11: 1 reports for this device; peer average 5.62/device2019-12: 0 reports for this device; peer average 5.41/device2020-01: 0 reports for this device; peer average 4.81/device2020-02: 0 reports for this device; peer average 5.57/device2020-03: 0 reports for this device; peer average 5.68/device2020-04: 0 reports for this device; peer average 3.57/device2020-05: 0 reports for this device; peer average 3.76/device2020-06: 9 reports for this device; peer average 5.14/device2020-07: 1 reports for this device; peer average 6.56/device2020-08: 3 reports for this device; peer average 4.64/device2020-09: 1 reports for this device; peer average 5.86/device2020-10: 0 reports for this device; peer average 5.55/device2020-11: 0 reports for this device; peer average 5.14/device2020-12: 2 reports for this device; peer average 5.31/device2021-01: 0 reports for this device; peer average 5.17/device2021-02: 0 reports for this device; peer average 4.89/device2021-03: 0 reports for this device; peer average 5.7/device2021-04: 0 reports for this device; peer average 5.26/device2021-05: 1 reports for this device; peer average 5.14/device2021-06: 2 reports for this device; peer average 5.83/device2021-07: 1 reports for this device; peer average 4.89/device2021-08: 0 reports for this device; peer average 4.3/device2021-09: 0 reports for this device; peer average 4.77/device2021-10: 0 reports for this device; peer average 6.17/device2021-11: 0 reports for this device; peer average 5.57/device2021-12: 1 reports for this device; peer average 5.56/device2022-01: 0 reports for this device; peer average 5.04/device2022-02: 2 reports for this device; peer average 5.15/device2022-03: 0 reports for this device; peer average 5.75/device2022-04: 0 reports for this device; peer average 4.98/device2022-05: 0 reports for this device; peer average 5.78/device2022-06: 1 reports for this device; peer average 6.3/device2022-07: 0 reports for this device; peer average 4.36/device2022-08: 2 reports for this device; peer average 4.59/device2022-09: 1 reports for this device; peer average 5/device2022-10: 3 reports for this device; peer average 4.76/device2022-11: 3 reports for this device; peer average 4.61/device2022-12: 1 reports for this device; peer average 4.04/device2023-01: 4 reports for this device; peer average 5.52/device2023-02: 1 reports for this device; peer average 4.59/device2023-03: 4 reports for this device; peer average 4.87/device2023-04: 13 reports for this device; peer average 4.78/device2023-05: 14 reports for this device; peer average 5.14/device2023-06: 4 reports for this device; peer average 4.78/device2023-07: 1 reports for this device; peer average 4.82/device2023-08: 0 reports for this device; peer average 4.44/device2023-09: 3 reports for this device; peer average 5.23/device2023-10: 9 reports for this device; peer average 5.1/device2023-11: 5 reports for this device; peer average 4.38/device2023-12: 4 reports for this device; peer average 4.79/device2024-01: 0 reports for this device; peer average 5.54/device2024-02: 0 reports for this device; peer average 5.46/device2024-03: 2 reports for this device; peer average 6.16/device2024-04: 0 reports for this device; peer average 6.04/device2024-05: 4 reports for this device; peer average 6.28/device2024-06: 1 reports for this device; peer average 5.39/device2024-07: 1 reports for this device; peer average 5.05/device2024-08: 0 reports for this device; peer average 5.01/device2024-09: 0 reports for this device; peer average 5.19/device2024-10: 5 reports for this device; peer average 5.7/device2024-11: 0 reports for this device; peer average 5.29/device2024-12: 0 reports for this device; peer average 4.06/device2025-01: 1 reports for this device; peer average 5.17/device2025-02: 0 reports for this device; peer average 4.46/device2025-03: 1 reports for this device; peer average 6.28/device2025-04: 1 reports for this device; peer average 4.39/device2025-05: 1 reports for this device; peer average 5.16/device2025-06: 0 reports for this device; peer average 5.08/device2025-07: 6 reports for this device; peer average 5.2/device2025-08: 1 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 4.85/device2025-10: 0 reports for this device; peer average 5.14/device2025-11: 1 reports for this device; peer average 5.55/device2025-12: 1 reports for this device; peer average 5.81/device2026-01: 0 reports for this device; peer average 5.63/device2026-02: 2 reports for this device; peer average 5.98/device2026-03: 1 reports for this device; peer average 6.2/device2026-04: 1 reports for this device; peer average 5.43/device2026-05: 0 reports for this device; peer average 6.19/device2026-06: 0 reports for this device; peer average 5.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0116.86
2019-0204.35
2019-0314.42
2019-0406.12
2019-0504.8
2019-0605.04
2019-0715.86
2019-0816.1
2019-0914.99
2019-1005.85
2019-1115.62
2019-1205.41
2020-0104.81
2020-0205.57
2020-0305.68
2020-0403.57
2020-0503.76
2020-0695.14
2020-0716.56
2020-0834.64
2020-0915.86
2020-1005.55
2020-1105.14
2020-1225.31
2021-0105.17
2021-0204.89
2021-0305.7
2021-0405.26
2021-0515.14
2021-0625.83
2021-0714.89
2021-0804.3
2021-0904.77
2021-1006.17
2021-1105.57
2021-1215.56
2022-0105.04
2022-0225.15
2022-0305.75
2022-0404.98
2022-0505.78
2022-0616.3
2022-0704.36
2022-0824.59
2022-0915
2022-1034.76
2022-1134.61
2022-1214.04
2023-0145.52
2023-0214.59
2023-0344.87
2023-04134.78
2023-05145.14
2023-0644.78
2023-0714.82
2023-0804.44
2023-0935.23
2023-1095.1
2023-1154.38
2023-1244.79
2024-0105.54
2024-0205.46
2024-0326.16
2024-0406.04
2024-0546.28
2024-0615.39
2024-0715.05
2024-0805.01
2024-0905.19
2024-1055.7
2024-1105.29
2024-1204.06
2025-0115.17
2025-0204.46
2025-0316.28
2025-0414.39
2025-0515.16
2025-0605.08
2025-0765.2
2025-0815.45
2025-0904.85
2025-1005.14
2025-1115.55
2025-1215.81
2026-0105.63
2026-0225.98
2026-0316.2
2026-0415.43
2026-0506.19
2026-0605.56
This device (reports/month)Average device in GEI (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
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  • 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
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  • VAI 2022-03-08 POM Medical LLC · 0 citations