Recall Z-1046-2022— Olympus Corporation of the Americas

Name: FDA recall Z-1046-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-08

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-03-08. It names one FDA 510(k) clearance: K023984. Product: BF-MP60: OES Bronchofiberscope. Reason: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-03-08
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESThe Olympus Optical Co.·cleared 2003-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BF-MP60: OES Bronchofiberscope

Reason for recall

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Data sourced from openFDA. This site is unofficial and independent of the FDA.