ModerateClass IIOngoing

FDA Devices recall · Reported August 9, 2023

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0382

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2265-2023.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW..

Q: 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.

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning …

Recall #: Z-2265-2023
Affected scope: 526.4 units
Initiated: May 15, 2023

Compiled from official public sources by the publisher. · Updated September 2026

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Olympus Corporation of the Americas recalled Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12… - a moderate-severity action.

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12… was recalled by Olympus Corporation of the Americas in August 9, 2023. Reason: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronc…. Check the official notice for the remedy. Verify recall #Z-2265-2023 with the FDA Devices before acting.

The recall

Olympus Corporation of the Americas issued this moderate-severity FDA Devices recall-Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronc….

Moderate
severity level: 526 units
affected scope: Class II
classification: August 9, 2023
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2265-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0382

Reason for recall

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-2265-2023
Date reported	August 9, 2023
Date initiated	May 15, 2023
Recalling firm	Olympus Corporation of the Americas
Firm location	Center Valley, PA
Affected scope	526.4 units
Distribution	Worldwide Distribution: US (Nationwide) and OUS (foreign) to 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.

Scale of Impact

526.4 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2265-2023) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2265-2023.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW..

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.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported August 9, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026