The Recall Desk
HighFDA (Devices)·Z-0717-2024·Announced 2024-01-24

Medical Fiber Cleaver System Recalled for Contamination Risk

Olympus Corporation recalled 236 fiber cleaver units distributed non-sterile but labeled as reusable and autoclavable. Without validated sterilization instructions, use on sterile fiber poses contamination risk.

What this means for you

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 an FDA Class II recall with no reported illness or injury. The hazard—contamination of sterile equipment from non-sterile devices—is theoretical but significant, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling the Soltive SuperPulsed Laser System TFL Fiber Cleaver, Model Number TFL-AFC. The recall affects 236 units distributed nationwide in the United States and globally, with all units sold prior to 2023 included.

The affected cleavers and strippers are provided non-sterile and labeled as reusable and autoclavable devices. Olympus has not validated cleaning and sterilization instructions for these products. Use of a non-sterile fiber stripper or cleaver on sterile fiber poses a risk of contamination.

Anyone who has obtained an affected unit should review recalled product information from Olympus Corporation of the Americas for guidance on appropriate action.

The recalled product

Product
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Fiber Optics Equipment
Hazard
  • contamination

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)

  • Lot Number: All units sold prior to 2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category