The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2264-2023·Announced 2023-08-09

Olympus SPiN Drive Forceps Recalled for EM Sensor Malfunction

Olympus SPiN Drive Forceps are being recalled due to an electromagnetic sensor malfunction that disables navigation functionality during endobronchial procedures, potentially causing procedural delays. No injuries reported.

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 Class II recall involves a risk-of-harm medical device where an EM sensor malfunction can disable critical navigation functionality during procedures. No patient injuries have been reported, making a High severity score appropriate per the rubric for risk-of-harm products without reported illness or injury.

Plain-English summary

Olympus Corporation of the Americas is recalling Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, Model INS-0372, due to an electromagnetic (EM) sensor tracking malfunction. The malfunction can disable the device's navigation functionality during endobronchial procedures and trigger a coil break warning message, potentially resulting in procedural delays.

The affected devices have worldwide distribution to the United States and eight foreign countries (China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan). Approximately 3,692 units are involved in the recall, identified by lot numbers 05456220113 and below (UDI-DI: 00815686020576).

Patients and healthcare providers should immediately stop using affected devices and contact Olympus Corporation of the Americas for instructions on replacement or repair. The EM sensor malfunction has not resulted in any reported patient injuries or illnesses. Healthcare facilities should verify whether their equipment includes affected lot numbers and implement corrective action as directed by the manufacturer.

The recalled product

Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model…
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical/Diagnostic Instruments
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: 00815686020576 Lot Numbers: 05456220113 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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