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

Veran : Endobronchial recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Veran : Endobronchial, 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 codesModel-UDI: INS-5500 View Optical Probe 00815686020729; INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx 00815686020651; INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC 00815686020644; INS-5411 0.016" Stylet, 1235 mm L, 10/Bx 00815686021191; INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx 00815686020637; INS-5323 Sliding stopper 00815686020712; INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx" 00815686021207 . All serial numbers and all lot numbers

Quantity recalled6318 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-2662-2023
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 Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx INS-5323 Sliding stopper INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx"

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?

Model-UDI: INS-5500 View Optical Probe 00815686020729; INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx 00815686020651; INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC 00815686020644; INS-5411 0.016" Stylet, 1235 mm L, 10/Bx 00815686021191; INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx 00815686020637; INS-5323 Sliding stopper 00815686020712; INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx" 00815686021207 . 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

This product is part of a recall event; the main page for the event is Veran : Endobronchial Always on Track recalled.

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

More recalls from Olympus Corporation of the Americas

All 415

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Other Heart & Vascular Devices recalls

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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