CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report

Veran : Endobronchial Always on Track recalled

Olympus Corporation of the Americas is recalling Veran : Endobronchial Always on Track, distributed nationwide in the US. The recall was initiated on 10 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesINS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX 00815686020613; INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx 00815686020590; INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx 00815686020576; INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx 00815686020538; INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" 00815686020538; INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC 00815686020477; INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm 00815686020446; INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm 00815686020439; INS-0050 vPad Patient Tracker, 5/Bx 00815686020408; INS-0048 vPad Connector Cable 00815686020392; All serial numbers and all lot numbers

Quantity recalled60102 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2664-2023
FDA event ID: 92893
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Aug 2023
FDA classified: 29 Sep 2023
Reported: 11 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

10 Aug 2023	Recall initiated by company
29 Sep 2023	Classified by FDA	+50 days
11 Oct 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Veran : Endobronchial Always on Track Models: INS-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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Nationwide Delaware

Questions about this recall

Why was it recalled?

Which lots are affected?

INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX 00815686020613; INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx 00815686020590; INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx 00815686020576; INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx 00815686020538; INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" 00815686020538; INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC 00815686020477; INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm 00815686020446; INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm 00815686020439; INS-0050 vPad Patient Tracker, 5/Bx 00815686020408; INS-0048 vPad Connector Cable 00815686020392; All serial numbers and all lot numbers

Where was it sold?

Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 92893

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023	CLASS II	Veran : Percutaneous Always on Track recalled	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran:SPiN Thoracic Navigation System recalled	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran : Percutaneous recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran : Endobronchial recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran Endobronchial recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide