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RELIANCE

Model Reliance 6500 · STERIS CORPORATION · DI 00724995229511

PUP — Endoscope Maintenance System · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-11 · 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 (11)

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: 11

12232023-07: 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 1.5/device2024-08: 0 reports for this device; peer average 1.25/device2024-09: 0 reports for this device; peer average 2.5/device2024-12: 0 reports for this device; peer average 1.13/device2025-01: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1.25/device2025-10: 3 reports for this device; peer average 1.5/device2025-12: 2 reports for this device; peer average 2.8/device2026-01: 1 reports for this device; peer average 1.5/device2026-03: 1 reports for this device; peer average 1.5/device2026-04: 1 reports for this device; peer average 1.5/device2026-05: 3 reports for this device; peer average 1.6/device0701020809120107101201030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0701
2024-0101
2024-0201.5
2024-0801.25
2024-0902.5
2024-1201.13
2025-0102
2025-0701.25
2025-1031.5
2025-1222.8
2026-0111.5
2026-0311.5
2026-0411.5
2026-0531.6
This device (reports/month)Average device in PUP (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