The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2265-2023·Announced 2023-08-09

Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction

Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial 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: FDA Class II medical device with a sensor malfunction affecting critical navigation function during surgical procedures. No injuries or hospitalizations reported, but the tracking malfunction represents a risk-of-harm scenario in minimally invasive procedures where navigation failure could compromise procedural safety.

Plain-English summary

Olympus Corporation of the Americas is recalling Always-On Tip Tracked Instruments (SPiN Drive instruments), specifically 19-gauge ANSO histology needles (Model INS-0382) with 12mm length and 1.8mm outer diameter. The recall affects 526.4 units distributed worldwide, including to the United States, China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan. Affected lot numbers are 04992210324 and below.

These instruments contain electromagnetic sensors designed to track and guide placement during endobronchial procedures, which are minimally invasive procedures performed within the bronchial tree. A malfunction in the electromagnetic sensor tracking system can impair navigation functionality and cause the system to report a coil break warning message, potentially resulting in procedural delays.

Healthcare providers who have received these instruments should stop using them and contact Olympus Corporation of the Americas for guidance on device replacement or return.

The recalled product

Product
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…
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endobronchial / Navigation
Hazard

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: 00815686020590 Lot Numbers: 04992210324 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 →

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