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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-03-26 | WL | Warning Letter | MedLine Industries, LP (NAMIC Division) | — |
| 2025-12-12 | OAI | Official action indicated | MedLine Industries, LP (NAMIC Division) | 5 |
| 2025-04-22 | NAI | No action indicated | MICROTEK MEDICAL LLC | 0 |
| 2024-03-18 | WL | Warning Letter | Medline Industries, LP | — |
| 2024-03-18 | WL | Warning Letter | Medline Industries, LP | — |
| 2024-01-29 | NAI | No action indicated | Medline Industries LP | 0 |
| 2024-01-29 | NAI | No action indicated | Medline Industries LP | 0 |
| 2024-01-22 | OAI | Official action indicated | Medline Industries, LP | 5 |
| 2024-01-22 | OAI | Official action indicated | Medline Industries, LP | 5 |
| 2023-11-01 | NAI | No action indicated | Medline Industries, LP | 0 |
| 2023-11-01 | NAI | No action indicated | Medline Industries, LP | 0 |
| 2023-07-26 | NAI | No action indicated | Medline Industries LP | 0 |
| 2023-07-26 | NAI | No action indicated | Medline Industries LP | 0 |
| 2023-02-10 | NAI | No action indicated | Centurion Medical Products, LP | 0 |
| 2022-04-06 | VAI | Voluntary action indicated | Medline Industries, LP | 0 |
| 2022-04-06 | VAI | Voluntary action indicated | Medline Industries, LP | 0 |
| 2022-04-05 | NAI | No action indicated | Centurion Medical Products, LP | 0 |
| 2022-03-28 | NAI | No action indicated | Medline Industries, LP | 0 |
| 2022-03-28 | NAI | No action indicated | Medline Industries, LP | 0 |
| 2020-06-11 | WL | Warning Letter | Centurion Medical Products, LP | — |
| 2019-11-01 | OAI | Official action indicated | Centurion Medical Products, LP | 5 |
| 2019-10-17 | NAI | No action indicated | Medline Industries LP | 0 |
| 2019-10-17 | NAI | No action indicated | Medline Industries LP | 0 |
| 2019-08-20 | OAI | Official action indicated | Centurion Medical Products, LP | 5 |
| 2014-11-07 | WL | Warning Letter | Excelsior Medical LLC | — |
| 2014-03-11 | WL | Warning Letter | Medline Industries, LP | — |
| 2014-03-11 | WL | Warning Letter | Medline Industries, LP | — |
| 2010-03-12 | WL | Warning Letter | Medline Industries, LP | — |
| 2010-03-12 | WL | Warning Letter | Medline Industries, LP | — |