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Model 0408800000 · STRYKER CORPORATION · DI 04546540591715

FYA — Gown, Surgical · Class II · 21 CFR 878.4040

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 (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (13)

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: 13

369122019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 3.33/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.44/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 2.33/device2019-07: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 2.14/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.75/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 1/device2022-07: 1 reports for this device; peer average 1/device2022-10: 1 reports for this device; peer average 1/device2023-01: 1 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 1/device2023-04: 1 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 2 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.75/device2024-04: 2 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2.5/device2024-06: 0 reports for this device; peer average 1.33/device2024-07: 1 reports for this device; peer average 1.33/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 2 reports for this device; peer average 2/device2025-01: 1 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 6/device2025-03: 0 reports for this device; peer average 1/device2025-04: 1 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 12/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device0102030405060710111201020304050607091001040608100710010203040910111202030405060709100102030405111202040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0203.33
2019-0302
2019-0401.44
2019-0502
2019-0602.33
2019-0701
2019-1001
2019-1101
2019-1201.5
2020-0101
2020-0201.5
2020-0302.14
2020-0401
2020-0501
2020-0602
2020-0701.75
2020-0901
2020-1001
2021-0101.5
2021-0403
2021-0603
2021-0801.5
2021-1001
2022-0711
2022-1011
2023-0111
2023-0203
2023-0301
2023-0411
2023-0901.5
2023-1022
2023-1102
2023-1202
2024-0201
2024-0301.75
2024-0422
2024-0502.5
2024-0601.33
2024-0711.33
2024-0901.67
2024-1022
2025-0111
2025-0206
2025-0301
2025-0411
2025-0502
2025-1102
2025-1203
2026-0204
2026-04012
2026-0502
2026-0602
This device (reports/month)Average device in FYA (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