Agency classClass IIOur severity:High FDA (Devices)·Z-2266-2023·Announced 2023-08-09

Endobronchial Cytology Needles Recalled for Electromagnetic Sensor Malfunction

Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical procedures, potentially causing procedural delays.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device with an electromagnetic sensor malfunction affecting navigation guidance during procedures. No reported illnesses or injuries are documented in the source material. The recall is classified as FDA Class II without hospitalization reports, placing it in the High severity category per the rubric.

Plain-English summary

Olympus Corporation of the Americas is recalling Always-On Tip Tracked Instruments (SPiN Drive) 21-gauge endobronchial cytology needles. The recalled devices (model INS-0392, lot numbers 04991210310 and below) were distributed to healthcare facilities in the United States and internationally. Approximately 1,158 units are affected.

These needles contain an electromagnetic sensor that guides physicians during endobronchial procedures. A malfunction in the sensor can disable navigation tracking during the procedure, causing the system to display a coil break warning message. This malfunction may result in procedural delays.

The devices were distributed worldwide to the United States, China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

The recalled product

Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology 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…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device
Hazard: sensor-malfunction
navigation-failure
Affected units: 1,158

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: 00815686020613 Lot Number: 04991210310 and below

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

See all →

Moderate
Olympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
Moderate
Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
Severe
Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30

Same hazard · sensor malfunction