Reported Oct 11, 2023 · Ongoing
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- VeranEndobronchial
- Always on Track ModelsINS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable
- Lot codes and dates
11 of 11 products
Products covered by this recall # Barcodes Product as published 1 00815686020613INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX 00815686020613 2 00815686020590INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx 00815686020590 3 00815686020576INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx 00815686020576 4 00815686020538INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx 00815686020538 5 00815686020538INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" 00815686020538 6 00815686020477INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC 00815686020477 7 00815686020446INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm 00815686020446 8 00815686020439INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm 00815686020439 9 00815686020408INS-0050 vPad Patient Tracker, 5/Bx 00815686020408 10 00815686020392INS-0048 vPad Connector Cable 00815686020392 11 All serial numbers and all lot numbers - Amount recalled
- 60102 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- DE
Why it was recalled
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
This product could cause temporary or reversible health problems — stop using it.
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