Home › OLYMPUS MEDICAL SYSTEMS CORP. › SINGLE USE ASPIRATION NEEDLE
SINGLE USE ASPIRATION NEEDLE
OLYMPUS MEDICAL SYSTEMS CORP. · Model NA-U401SX-4025N · UDI-DI 04953170402012
KTI
Prescription
1
510(k) clearances
977
Adverse events (8 deaths)
12
Recalls
65
Facilities
Description
Single Use Aspiration Needle NA-U401SX-4025N
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.