Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 11, 2023
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 Guidewir
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufact…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Olympus Corporation of the Americas recalled Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm … - a moderate-severity action.
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm … was recalled by Olympus Corporation of the Americas in October 11, 2023. Reason: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning La…. Check the official notice for the remedy. Verify recall #Z-2664-2023 with the FDA Devices before acting.
The recall
Olympus Corporation of the Americas issued this moderate-severity FDA Devices recall-Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning La….
- Moderate
- severity level
- 60K units
- affected scope
- Class II
- classification
- October 11, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2664-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2664-2023) was formally reported on October 11, 2023, with the manufacturer initiating the action on August 10, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Olympus Corporation of the Americas is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 60102 units.
The documented reason for this recall is: 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 insuffi… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
60102 units
Related Recalls
6
3 from same agency
Product description
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
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2664-2023 |
| Date reported | October 11, 2023 |
| Date initiated | August 10, 2023 |
| Recalling firm | Olympus Corporation of the Americas |
| Firm location | Center Valley, PA |
| Affected scope | 60102 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2664-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Olympus Corporation of the Americas. Units affected: 60102 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2664-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2664-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 11, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.