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.
11 linked reportsMalfunction 11
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 1 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 3 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 3 |
| 2019-11 | 0 | 4 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 3 |
| 2020-04 | 0 | 5 |
| 2020-05 | 0 | 2 |
| 2020-10 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-04 | 0 | 2 |
| 2021-07 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2022-02 | 0 | 3 |
| 2022-05 | 0 | 2 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 1 |
| 2022-08 | 3 | 2 |
| 2022-09 | 0 | 1 |
| 2022-10 | 3 | 3 |
| 2023-01 | 0 | 3 |
| 2023-02 | 3 | 3 |
| 2023-03 | 0 | 3 |
| 2023-08 | 2 | 2 |
| 2023-12 | 0 | 3.67 |
| 2024-01 | 0 | 4.75 |
| 2024-02 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 2 |
| 2024-11 | 0 | 3 |
| 2025-05 | 0 | 1 |
| 2025-08 | 0 | 2 |
| 2025-10 | 0 | 1 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 2 |
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-05-25 | Z-1793-2022 | Class III | Open, Classified | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.Distribution: US Nationwide distribution. | a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-08-28 | 3004080920-2023-00004 | Malfunction | Available | exact di |
| 2023-02-10 | 3004080920-2023-00002 | Malfunction | Available | catalog number |
| 2022-10-28 | 3004080920-2022-00006 | Malfunction | Available | catalog number |
| 2022-08-31 | 3004080920-2022-00004 | Malfunction | Available | catalog number |
Showing the most recent 4 of 11 linked reports.
Regulatory clearances
- 510(k)K251452Substantially equivalent (SESE) · 2025-06-06clearance family
- 510(k)K250044Substantially equivalent (SESE) · 2025-02-06clearance family
- 510(k)K231490Substantially equivalent (SESE) · 2023-08-07clearance family
- 510(k)K183294Substantially equivalent (SESE) · 2019-01-03clearance family
- 510(k)K181429Substantially equivalent (SESE) · 2018-06-13clearance family
- 510(k)K172752Substantially equivalent (SESE) · 2018-02-09clearance family
- 510(k)K172474Substantially equivalent (SESE) · 2017-12-29clearance family
- 510(k)K171504Substantially equivalent (SESE) · 2017-08-22clearance family
Predicate lineage
- K171504
K172474
Cited as predicate by: K183294
- K172752
- K181429
- K183294
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
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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