Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionVERIFY0724995FPSTEAMINTGRNGM7
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.
14 linked reportsMalfunction 14
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.5 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2020-10 | 0 | 4 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-03 | 0 | 4 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 3 |
| 2021-08 | 0 | 7 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 3.29 |
| 2021-11 | 0 | 5.67 |
| 2021-12 | 0 | 4 |
| 2022-01 | 0 | 4 |
| 2022-02 | 0 | 6 |
| 2022-03 | 0 | 12 |
| 2022-04 | 0 | 9 |
| 2022-05 | 0 | 6 |
| 2022-06 | 0 | 2 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 1 |
| 2022-11 | 0 | 1 |
| 2023-02 | 0 | 1 |
| 2023-05 | 0 | 2.25 |
| 2023-08 | 0 | 1 |
| 2023-10 | 0 | 1.67 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-01 | 1 | 1.67 |
| 2024-03 | 1 | 1.67 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1 |
| 2024-07 | 1 | 1 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 2 |
| 2024-11 | 1 | 1.67 |
| 2024-12 | 0 | 1 |
| 2025-01 | 1 | 2 |
| 2025-06 | 3 | 2.5 |
| 2025-07 | 1 | 2 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 2 |
| 2025-12 | 0 | 2 |
| 2026-01 | 2 | 1.5 |
| 2026-02 | 3 | 2 |
| 2026-04 | 0 | 1 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
14 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-13 | 3007412809-2026-00001 | Malfunction | Available | catalog number |
| 2026-01-16 | 24093067 | Malfunction | Available | catalog number |
| 2025-07-30 | 3007412809-2025-00003 | Malfunction | Available | model number |
| 2025-06-11 | 3007412809-2025-00002 | Malfunction | Available | catalog number |
| 2025-01-05 | 3007412809-2025-00001 | Malfunction | Available | model number |
| 2024-11-14 | 3007412809-2024-00001 | Malfunction | Available | model number |
| 2024-07-03 | 3000251274-2024-00004 | Malfunction | Available | exact di |
| 2024-03-28 | 3000251274-2024-00002 | Malfunction | Available | exact di |
| 2024-01-12 | 3000251274-2024-00001 | Malfunction | Available | exact di |
Showing the most recent 9 of 14 linked reports.
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 | — |
Similar devices
- "Burkhart Autoclave Indicator Tape 1"" (60yrds)" BURKHART DENTAL SUPPLY CO., THE
- "Burkhart Autoclave Indicator Tape 1/2"" (60yrds)" BURKHART DENTAL SUPPLY CO., THE
- "Burkhart Autoclave Indicator Tape 3/4"" (60yrds)" BURKHART DENTAL SUPPLY CO., THE
- "EO Chex 1"" Indicator Tape - 36 rolls/case" PROPPER MANUFACTURING COMPANY, INC.
- "EO Chex 3/4"" Indicator Tape - 48 rolls/case" PROPPER MANUFACTURING COMPANY, INC.
- "Getinge Assured Green Tape 1""" STERITEC PRODUCT MFG. CO., INC.
- "Getinge Assured Green Tape 3/4""" STERITEC PRODUCT MFG. CO., INC.
- "Getinge Blue Sterilization Indicator Tape 1""" STERITEC PRODUCT MFG. CO., INC.
- "Getinge Sterilization Indicator Tape 1""" STERITEC PRODUCT MFG. CO., INC.
- "Getinge Sterilization Indicator Tape 1/2""" STERITEC PRODUCT MFG. CO., INC.
- "Getinge Sterilization Indicator Tape 3/4""" STERITEC PRODUCT MFG. CO., INC.
- "Propper 1"" Steri-Dot Process Indicator" PROPPER MANUFACTURING COMPANY, INC.
Select up to two to place side-by-side with this device.