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Richard Wolf GmbH · Model 8466801 · UDI-DI 04055207017494
10
510(k) clearances
977
Adverse events (8 deaths)
12
Recalls
65
Facilities
Description
CONTROL INSTRUMENT FOR BRONCH. OD 28MM WL 429mm, for use with bronchoscopes, flexible forceps, scissors, cytology brushes, along with other endoscopic accessories, for use with telescopes Ø 5.5mm, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-06 | Olympus Corporation of the Americas | Potential for undetected, deformed a-traumatic tips. |
| 2025-04-04 | Integra LifeSciences Corp. (NeuroSciences) | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. |
| 2023-05-16 | Bryan Medical Inc | Devices were mislabeled. |
| 2018-10-17 | Richard Wolf GmbH | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
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