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Isolibrium

Model 2972 · STRYKER CORPORATION · DI 07613327278453

IKZ — Bed, Patient Rotation, Powered · Class II · 21 CFR 890.5225

UDILibrary device dossier · generated 2026-09-12 · 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-2215-2021Class 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 (16)

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: 12 · Injury: 4

23562019-01: 1 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2020-04: 1 reports for this device; peer average 1/device2020-07: 1 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-01: 3 reports for this device; peer average 3/device2021-02: 1 reports for this device; peer average 1/device2021-03: 1 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2022-01: 1 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 5/device2023-03: 1 reports for this device; peer average 1.5/device2023-04: 1 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 2/device2024-04: 1 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-01: 1 reports for this device; peer average 1/device2025-04: 1 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 6/device2025-12: 0 reports for this device; peer average 3/device2026-01: 1 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2/device2026-04: 1 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 2/device01060407100102031001040203040610010204061001040607111201020406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0111
2019-0601
2020-0411
2020-0711
2020-1001
2021-0133
2021-0211
2021-0311
2021-1001
2022-0111
2022-0401
2023-0205
2023-0311.5
2023-0411
2023-0602
2023-1001
2024-0101
2024-0202
2024-0411
2024-0601
2024-1001
2025-0111
2025-0411
2025-0601
2025-0701
2025-1106
2025-1203
2026-0111
2026-0202
2026-0411
2026-0602
This device (reports/month)Average device in IKZ (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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  • 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
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  • VAI 2022-03-08 POM Medical LLC · 0 citations