Karl Storz Endoscopy: Laser Surgical Instruments Recalled for Sterility Concerns

Agency Publication Date: May 13, 2024

Summary

Karl Storz Endoscopy is recalling 85 Laser Application Instruments because there is no evidence of a validated cleaning and sterilization method for these reusable devices. Without a proven sterilization process, these surgical tools lack sterility assurance when reused on subsequent patients. Consumers should contact their healthcare provider or the manufacturer to ensure these specific instruments are no longer in active surgical use.

Risk

Using instruments that have not been properly sterilized poses an increased risk of exposing patients to serious infections during surgical procedures.

What You Should Do

Identify if your facility has the affected LASER Application Instruments by checking the reference numbers and UDI-DI on the device or packaging: LASER Application Instrument (23 cm), REF: 8694 (UDI-DI: 04048551216392) or LEUNIG-GREVERS LASER Application, REF: 461000 (UDI-DI: 04048551164860).
Check all inventory for these instruments, as the recall affects all lots of the specified models.
Immediately stop using and reprocessing these instruments for surgical procedures until further notice from the manufacturer.
Contact Karl Storz Endoscopy at their El Segundo, California headquarters or your healthcare provider for instructions on returning or servicing the devices and to discuss potential patient impact.
For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: LASER Application Instrument, 23 cm

Model / REF:

8694

04048551216392

Lot Numbers:

All lots

Product: LEUNIG-GREVERS LASER Application

Model / REF:

461000

04048551164860

Lot Numbers:

All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94389

Status: Active

Manufacturer: Karl Storz Endoscopy

Sold By: Karl Storz Endoscopy

Manufactured In: United States

Units Affected: 85

Distributed To: Ohio, California, Florida, Massachusetts, Texas, Kentucky, Wisconsin, Michigan, Minnesota, Arkansas, Nebraska, Illinois, New York, Hawaii

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 your facility has the affected LASER Application Instruments by checking the reference numbers and UDI-DI on the device or packaging: LASER Application Instrument (23 cm), REF: 8694 (UDI-DI: 04048551216392) or LEUNIG-GREVERS LASER Application, REF: 461000 (UDI-DI: 04048551164860).

Check all inventory for these instruments, as the recall affects all lots of the specified models.

Immediately stop using and reprocessing these instruments for surgical procedures until further notice from the manufacturer.

Contact Karl Storz Endoscopy at their El Segundo, California headquarters or your healthcare provider for instructions on returning or servicing the devices and to discuss potential patient impact.

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