KARL STORZ Endoscopy-America Voluntarily Recalls Certain Flexible Endoscopes
1 April 2022
Recall Updates the Reprocessing Instructions for Affected Urology and ENT Scopes
Only Users with Access to Appropriate Sterilization Methods Should Continue to Use the Devices
KARL STORZ Endoscopy-America, Inc. (KSEA) is updating the reprocessing instructions of flexible, single-channel endoscopes with an attached T-Luer design. These endoscopes are intended for various urological, bronchoscopic, and ENT indications for diagnostic and therapeutic use. KSEA is advising that users should discontinue use of all high-level disinfection methods and, for certain models, liquid chemical sterilization to reprocess these devices. Only users with access to appropriate sterilization methods should continue to use the devices.
Affected KSEA customers will receive an Urgent Medical Device Recall Notice with further details. Please refer to the links below:
KSEA customers are encouraged to carefully review the instructions in the Urgent Medical Device Recall Notice and to notify KSEA and/or FDA’s MedWatch Adverse Event Reporting program of any adverse events or quality problems associated with the use of the affected endoscopes.