Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
130 linked reportsMalfunction 130
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-08 | 2 | 2 |
| 2020-04 | 2 | 2 |
| 2020-09 | 0 | 1 |
| 2020-12 | 2 | 2 |
| 2021-05 | 2 | 2 |
| 2021-07 | 3 | 3 |
| 2021-09 | 0 | 1 |
| 2021-11 | 3 | 3 |
| 2021-12 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-07 | 1 | 1 |
| 2023-01 | 2 | 2 |
| 2023-02 | 46 | 23.5 |
| 2023-03 | 29 | 15 |
| 2023-04 | 11 | 6 |
| 2023-05 | 2 | 2 |
| 2023-06 | 1 | 1 |
| 2023-07 | 1 | 1 |
| 2023-08 | 1 | 1 |
| 2023-10 | 9 | 9 |
| 2024-01 | 1 | 8.67 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 9 |
| 2024-04 | 1 | 3.5 |
| 2024-05 | 1 | 1 |
| 2024-06 | 1 | 2 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2025-01 | 0 | 3 |
| 2025-02 | 0 | 2.67 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 1.5 |
| 2025-05 | 0 | 1.5 |
| 2025-08 | 0 | 1.33 |
| 2025-10 | 1 | 1.5 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 6 |
| 2026-01 | 0 | 6 |
| 2026-02 | 2 | 1.5 |
| 2026-03 | 3 | 4.4 |
| 2026-04 | 0 | 5.33 |
| 2026-05 | 3 | 2.2 |
| 2026-06 | 0 | 4 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-03-17 | Z-1475-2023 | Class II | Open, Classified | Light 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 patientDistribution: Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia. | 1,358,520 covers | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-01 | 1043572-2026-00044 | Malfunction | Available | catalog number |
| 2026-03-13 | 1043572-2026-00025 | Malfunction | Available | catalog number |
| 2026-02-10 | 24303090 | Malfunction | Available | catalog number |
| 2025-10-31 | 1043572-2025-00096 | Malfunction | Available | model number |
| 2024-06-18 | 1043572-2024-00042 | Malfunction | Available | exact di |
| 2024-05-16 | 1043572-2024-00031 | Malfunction | Available | exact di |
| 2024-04-05 | 1043572-2024-00020 | Malfunction | Available | exact di |
| 2024-01-05 | 1043572-2024-00001 | Malfunction | Available | exact di |
| 2023-10-18 | 1043572-2023-00151 | Malfunction | Available | catalog number |
| 2023-10-11 | 1043572-2023-00147 | Malfunction | Available | catalog number |
| 2023-10-11 | 1043572-2023-00146 | Malfunction | Available | catalog number |
| 2023-08-02 | 1043572-2023-00130 | Malfunction | Available | exact di |
| 2023-07-20 | 1043572-2023-00127 | Malfunction | Available | exact di |
| 2023-06-15 | 1043572-2023-00119 | Malfunction | Available | exact di |
| 2023-05-18 | 1043572-2023-00103 | Malfunction | Available | exact di |
Showing the most recent 106 of 130 linked reports.
Showing 1–15 of 106
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-04-16 | NAI | No action indicated | Steris Corporation | 0 |
| 2026-04-16 | NAI | No action indicated | Steris Corporation | 0 |
| 2026-04-03 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2026-03-12 | NAI | No action indicated | Isomedix Operations Inc | 0 |
| 2026-02-26 | VAI | Voluntary action indicated | Steris S.p.A. | 1 |
| 2026-02-12 | VAI | Voluntary action indicated | Synergy Health Ede BV | 2 |
| 2026-02-12 | NAI | No action indicated | Synergy Health Marseille | 0 |
| 2025-12-12 | OAI | Official action indicated | Black Diamond Video Inc. | 3 |
| 2025-08-01 | VAI | Voluntary action indicated | STERIS Laboratories, Inc. | 2 |
| 2025-06-18 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2025-06-17 | NAI | No action indicated | Isomedix Operations Inc | 0 |
| 2025-06-05 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2025-04-01 | NAI | No action indicated | Steris Corporation | 0 |
| 2025-02-21 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2025-01-23 | NAI | No action indicated | Synergy Health Allershausen GmbH | 0 |
| 2024-12-12 | VAI | Voluntary action indicated | Isomedix Operations, Inc | 0 |
| 2024-12-05 | NAI | No action indicated | Steris (Synergy Health Ede BV) | 0 |
| 2024-11-21 | VAI | Voluntary action indicated | Steris Applied Sterilization Technologies ULC | 2 |
| 2024-09-23 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2024-09-19 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2015-02-20 | WL | Warning Letter | Key Surgical LLC | — |
| 2014-05-22 | WL | Warning Letter | Isomedix Operations, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Albert Browne Ltd. | — |
| 2011-02-09 | WL | Warning Letter | Steris Corporation | — |
| 2011-02-09 | WL | Warning Letter | Steris Corporation | — |
| 2010-09-27 | WL | Warning Letter | Isomedix Operations, Inc. | — |
| 2010-04-20 | INJ | Injunction | Steris Corporation | — |
| 2010-04-20 | INJ | Injunction | Steris Corporation | — |
| 2009-07-31 | WL | Warning Letter | Medivators Inc | — |
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