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Unnamed device

Model Sterile Lighthandle Cover · STERIS CORPORATION · DI 00724995150136

FTA — Light, Surgical, Accessories · Class II · 21 CFR 878.4580

UDILibrary device dossier · generated 2026-09-15 · 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
2023-03-17Z-1475-2023Class IIOpen, ClassifiedLight handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patientcode info di

Adverse-event reports — MAUDE (130)

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: 130

122335462019-08: 2 reports for this device; peer average 2/device2020-04: 2 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2020-12: 2 reports for this device; peer average 2/device2021-05: 2 reports for this device; peer average 2/device2021-07: 3 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 1/device2021-11: 3 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-07: 1 reports for this device; peer average 1/device2023-01: 2 reports for this device; peer average 2/device2023-02: 46 reports for this device; peer average 23.5/device2023-03: 29 reports for this device; peer average 15/device2023-04: 11 reports for this device; peer average 6/device2023-05: 2 reports for this device; peer average 2/device2023-06: 1 reports for this device; peer average 1/device2023-07: 1 reports for this device; peer average 1/device2023-08: 1 reports for this device; peer average 1/device2023-10: 9 reports for this device; peer average 9/device2024-01: 1 reports for this device; peer average 8.67/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 9/device2024-04: 1 reports for this device; peer average 3.5/device2024-05: 1 reports for this device; peer average 1/device2024-06: 1 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 2.67/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.33/device2025-10: 1 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 6/device2026-01: 0 reports for this device; peer average 6/device2026-02: 2 reports for this device; peer average 1.5/device2026-03: 3 reports for this device; peer average 4.4/device2026-04: 0 reports for this device; peer average 5.33/device2026-05: 3 reports for this device; peer average 2.2/device2026-06: 0 reports for this device; peer average 4/device08040912050709111202070102030405060708100102030405060910010203040508101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0822
2020-0422
2020-0901
2020-1222
2021-0522
2021-0733
2021-0901
2021-1133
2021-1201
2022-0201
2022-0711
2023-0122
2023-024623.5
2023-032915
2023-04116
2023-0522
2023-0611
2023-0711
2023-0811
2023-1099
2024-0118.67
2024-0201
2024-0309
2024-0413.5
2024-0511
2024-0612
2024-0901
2024-1001
2025-0103
2025-0202.67
2025-0301
2025-0401.5
2025-0501.5
2025-0801.33
2025-1011.5
2025-1101
2025-1206
2026-0106
2026-0221.5
2026-0334.4
2026-0405.33
2026-0532.2
2026-0604
This device (reports/month)Average device in FTA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STERIS CORPORATION

  • Warning Letter 2015-02-20 Key Surgical LLC
  • Warning Letter 2014-05-22 Isomedix Operations, Inc.
  • Warning Letter 2012-05-29 Albert Browne Ltd.
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2010-09-27 Isomedix Operations, Inc.
  • Injunction 2010-04-20 Steris Corporation
  • Injunction 2010-04-20 Steris Corporation
  • Warning Letter 2009-07-31 Medivators Inc
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-03 Isomedix Operations Inc. · 0 citations
  • NAI 2026-03-12 Isomedix Operations Inc · 0 citations
  • VAI 2026-02-26 Steris S.p.A. · 1 citations
  • VAI 2026-02-12 Synergy Health Ede BV · 2 citations
  • NAI 2026-02-12 Synergy Health Marseille · 0 citations
  • OAI 2025-12-12 Black Diamond Video Inc. · 3 citations
  • VAI 2025-08-01 STERIS Laboratories, Inc. · 2 citations
  • NAI 2025-06-18 Isomedix Operations Inc. · 0 citations
  • NAI 2025-06-17 Isomedix Operations Inc · 0 citations
  • NAI 2025-06-05 Isomedix Operations, Inc. · 0 citations
  • NAI 2025-04-01 Steris Corporation · 0 citations
  • NAI 2025-02-21 Isomedix Operations Inc. · 0 citations
  • NAI 2025-01-23 Synergy Health Allershausen GmbH · 0 citations
  • VAI 2024-12-12 Isomedix Operations, Inc · 0 citations
  • NAI 2024-12-05 Steris (Synergy Health Ede BV) · 0 citations
  • VAI 2024-11-21 Steris Applied Sterilization Technologies ULC · 2 citations
  • NAI 2024-09-23 Isomedix Operations, Inc. · 0 citations
  • NAI 2024-09-19 Isomedix Operations, Inc. · 0 citations