Karl Storz Endoscopy: Flexible Intubation Endoscopes Recalled Due to Sterility Assurance Issues

Agency Publication Date: September 15, 2023

Summary

Karl Storz Endoscopy is recalling 218 units of its Five S 5 3x65 flexible intubation endoscopes because the manufacturer cannot confirm the sterility of the devices. These sterile, single-use endoscopes are used by medical professionals for airway management and intubation. Without confirmed sterility, using these devices could lead to patient infections or other serious health complications. This recall includes all lots with remaining shelf life globally, specifically identifying two lots imported into the United States.

Risk

The sterility of these single-use medical devices cannot be guaranteed, which may introduce pathogens directly into a patient's airway during intubation procedures. This poses a significant risk of localized or systemic infections for patients undergoing medical procedures.

What You Should Do

Identify if you have the Five S 5 3x65 flexible intubation endoscopes by checking the product packaging for REF: 0915612-06 and UDI: 04048551446690.
Check for specific U.S. imported lot numbers 500472 and 500461, as well as any other lots currently within their shelf life.
Immediately stop using any affected endoscopes and quarantine them to prevent accidental use in medical procedures.
Contact your healthcare provider or Karl Storz Endoscopy at their El Segundo, California headquarters to arrange for further instructions and potential product return.
For additional information, contact the FDA at 1-888-463-6332 or visit the FDA medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Five S 5 3x65 Flexible Intubation Endoscope

Model / REF:

REF: 0915612-06

Lot Numbers:

500472

500461

All lots with remaining shelf life (Globally)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92796

Status: Active

Manufacturer: Karl Storz Endoscopy

Sold By: Karl Storz Endoscopy

Manufactured In: United States

Units Affected: 218 units

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the Five S 5 3x65 flexible intubation endoscopes by checking the product packaging for REF: 0915612-06 and UDI: 04048551446690.

Check for specific U.S. imported lot numbers 500472 and 500461, as well as any other lots currently within their shelf life.

Immediately stop using any affected endoscopes and quarantine them to prevent accidental use in medical procedures.

Contact your healthcare provider or Karl Storz Endoscopy at their El Segundo, California headquarters to arrange for further instructions and potential product return.

For additional information, contact the FDA at 1-888-463-6332 or visit the FDA medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.