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S3

Model 3005 · STRYKER CORPORATION · DI 07613327278309

FNL — Bed, Ac-Powered Adjustable Hospital · Class II · 21 CFR 880.5100

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2021-05-12Z-2216-2021Class IIOpen, ClassifiedMedical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionalscode info di

Adverse-event reports — MAUDE (220)

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: 209 · Injury: 11

81624322019-01: 8 reports for this device; peer average 3.24/device2019-02: 1 reports for this device; peer average 2.11/device2019-03: 1 reports for this device; peer average 1.39/device2019-04: 5 reports for this device; peer average 3.6/device2019-05: 1 reports for this device; peer average 3.28/device2019-06: 1 reports for this device; peer average 1.14/device2019-07: 7 reports for this device; peer average 3.44/device2019-08: 0 reports for this device; peer average 1.13/device2019-09: 0 reports for this device; peer average 1.25/device2019-10: 8 reports for this device; peer average 3.74/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1.58/device2020-01: 8 reports for this device; peer average 3.57/device2020-02: 0 reports for this device; peer average 1.93/device2020-03: 0 reports for this device; peer average 2/device2020-04: 7 reports for this device; peer average 2.79/device2020-05: 0 reports for this device; peer average 1/device2020-06: 2 reports for this device; peer average 1.42/device2020-07: 7 reports for this device; peer average 4.9/device2020-08: 0 reports for this device; peer average 1.04/device2020-09: 1 reports for this device; peer average 3.67/device2020-10: 6 reports for this device; peer average 3.5/device2020-11: 0 reports for this device; peer average 1.07/device2020-12: 0 reports for this device; peer average 2.32/device2021-01: 21 reports for this device; peer average 8.24/device2021-02: 4 reports for this device; peer average 1.6/device2021-03: 1 reports for this device; peer average 2.03/device2021-04: 5 reports for this device; peer average 3.06/device2021-05: 0 reports for this device; peer average 6/device2021-06: 1 reports for this device; peer average 1.76/device2021-07: 6 reports for this device; peer average 2.34/device2021-08: 0 reports for this device; peer average 2.8/device2021-09: 1 reports for this device; peer average 1.81/device2021-10: 8 reports for this device; peer average 3.88/device2021-11: 0 reports for this device; peer average 2.08/device2021-12: 0 reports for this device; peer average 3.45/device2022-01: 8 reports for this device; peer average 3.65/device2022-02: 0 reports for this device; peer average 1.68/device2022-03: 0 reports for this device; peer average 1.83/device2022-04: 8 reports for this device; peer average 2.47/device2022-05: 0 reports for this device; peer average 1.41/device2022-06: 1 reports for this device; peer average 2.89/device2022-07: 7 reports for this device; peer average 3.76/device2022-08: 1 reports for this device; peer average 1.26/device2022-09: 0 reports for this device; peer average 2.33/device2022-10: 7 reports for this device; peer average 3.03/device2022-11: 0 reports for this device; peer average 2.31/device2022-12: 2 reports for this device; peer average 3.79/device2023-01: 7 reports for this device; peer average 2.25/device2023-02: 0 reports for this device; peer average 1.47/device2023-03: 0 reports for this device; peer average 3.27/device2023-04: 9 reports for this device; peer average 5.09/device2023-05: 1 reports for this device; peer average 6.26/device2023-06: 0 reports for this device; peer average 3.73/device2023-07: 5 reports for this device; peer average 5.07/device2023-08: 0 reports for this device; peer average 7.5/device2023-09: 0 reports for this device; peer average 5.9/device2023-10: 8 reports for this device; peer average 3.76/device2023-11: 0 reports for this device; peer average 8.22/device2023-12: 0 reports for this device; peer average 8.71/device2024-01: 6 reports for this device; peer average 4.85/device2024-02: 0 reports for this device; peer average 2.5/device2024-03: 0 reports for this device; peer average 7.12/device2024-04: 6 reports for this device; peer average 5.81/device2024-05: 0 reports for this device; peer average 7.91/device2024-06: 0 reports for this device; peer average 9.73/device2024-07: 6 reports for this device; peer average 5.69/device2024-08: 1 reports for this device; peer average 7.77/device2024-09: 0 reports for this device; peer average 6.57/device2024-10: 5 reports for this device; peer average 4.57/device2024-11: 0 reports for this device; peer average 13.53/device2024-12: 0 reports for this device; peer average 7.73/device2025-01: 5 reports for this device; peer average 7.04/device2025-02: 0 reports for this device; peer average 5.57/device2025-03: 1 reports for this device; peer average 4.91/device2025-04: 7 reports for this device; peer average 6.62/device2025-05: 0 reports for this device; peer average 5.12/device2025-06: 0 reports for this device; peer average 9.32/device2025-07: 0 reports for this device; peer average 6.46/device2025-08: 0 reports for this device; peer average 4.02/device2025-09: 0 reports for this device; peer average 9.07/device2025-10: 3 reports for this device; peer average 3.32/device2025-11: 0 reports for this device; peer average 8.51/device2025-12: 0 reports for this device; peer average 8.49/device2026-01: 3 reports for this device; peer average 4.16/device2026-02: 0 reports for this device; peer average 5.84/device2026-03: 0 reports for this device; peer average 6.43/device2026-04: 3 reports for this device; peer average 7.36/device2026-05: 0 reports for this device; peer average 21.67/device2026-06: 0 reports for this device; peer average 32.34/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0183.24
2019-0212.11
2019-0311.39
2019-0453.6
2019-0513.28
2019-0611.14
2019-0773.44
2019-0801.13
2019-0901.25
2019-1083.74
2019-1101.33
2019-1201.58
2020-0183.57
2020-0201.93
2020-0302
2020-0472.79
2020-0501
2020-0621.42
2020-0774.9
2020-0801.04
2020-0913.67
2020-1063.5
2020-1101.07
2020-1202.32
2021-01218.24
2021-0241.6
2021-0312.03
2021-0453.06
2021-0506
2021-0611.76
2021-0762.34
2021-0802.8
2021-0911.81
2021-1083.88
2021-1102.08
2021-1203.45
2022-0183.65
2022-0201.68
2022-0301.83
2022-0482.47
2022-0501.41
2022-0612.89
2022-0773.76
2022-0811.26
2022-0902.33
2022-1073.03
2022-1102.31
2022-1223.79
2023-0172.25
2023-0201.47
2023-0303.27
2023-0495.09
2023-0516.26
2023-0603.73
2023-0755.07
2023-0807.5
2023-0905.9
2023-1083.76
2023-1108.22
2023-1208.71
2024-0164.85
2024-0202.5
2024-0307.12
2024-0465.81
2024-0507.91
2024-0609.73
2024-0765.69
2024-0817.77
2024-0906.57
2024-1054.57
2024-11013.53
2024-1207.73
2025-0157.04
2025-0205.57
2025-0314.91
2025-0476.62
2025-0505.12
2025-0609.32
2025-0706.46
2025-0804.02
2025-0909.07
2025-1033.32
2025-1108.51
2025-1208.49
2026-0134.16
2026-0205.84
2026-0306.43
2026-0437.36
2026-05021.67
2026-06032.34
This device (reports/month)Average device in FNL (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
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
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