Karl Storz Endoscopes Recalled Due to Unapproved Reprocessing Instructions

Agency Publication Date: January 30, 2025

Summary

Karl Storz Endoscopy is recalling 6,005 endoscopes because their instructions for use contain cleaning and sterilization methods that have not been reviewed or approved by the FDA. The affected devices include several models of Uretero-Renoscopes and Cysto-Urethroscopes used in surgical procedures. Using sterilization methods that have not been validated could lead to ineffective cleaning between patients, although no injuries or incidents have been reported to date. Healthcare facilities should contact the manufacturer to receive updated reprocessing information or arrange for returns.

Risk

Reprocessing instructions that have not been vetted for safety and efficacy by the FDA may fail to properly sterilize the medical devices between uses. This poses a risk of cross-contamination and the potential for patient infections.

What You Should Do

This recall affects Karl Storz Michel Uretero-Renoscopes, Cysto-Urethroscopes, and various pediatric and standard Uretero-Renoscope models.
Identify if your device is affected by checking the model (REF) numbers, which include 27003L, 27030KA, 27030KB, 27002KP, 27010L, 27000L, 27001L, 27011L, 27002L, 27010K, 27000K, 27001K, 27002K, and 27011K. See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices if you are unable to follow currently validated and approved sterilization protocols.
Contact Karl Storz Endoscopy or your authorized medical distributor to arrange for a device return, replacement, or to receive corrected reprocessing instructions.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this medical device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: KARL STORZ - ENDOSKOPE MICHEL Uretero-Renoscope, 9.5 Fr., 43cm

Variants: 9.5 Fr., 43cm

Model / REF:

27003L

UDI:

04048551231296

RxONLY

Product: KARL STORZ - ENDOSKOPE Cysto-Urethroscope

Variants: Non-Sterile

Model / REF:

27030KA

UDI:

04048551232095

Product: KARL STORZ - ENDOSKOPE Pediatric Cysto-Urethroscope

Variants: Non-Sterile

Model / REF:

27030KB

UDI:

04048551232118

Product: KARL STORZ - ENDOSKOPE Pediatric Uretero-Renoscope

Variants: 7.3 Fr., Non-Sterile

Model / REF:

27002KP

UDI:

04048551231234

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 7 Fr., 43cm

Variants: 7 Fr., 43cm, Non-Sterile

Model / REF:

27010L

UDI:

04048551231333

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 7 Fr., 6 degree, 43 cm

Variants: 7 Fr., 6 degree, 43 cm, Non-Sterile

Model / REF:

27000L

UDI:

04048551311271

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 8 Fr., 6 degree, 43 cm

Variants: 8 Fr., 6 degree, 43 cm, Non-Sterile

Model / REF:

27001L

UDI:

04048551231210

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 8 Fr., 6 degree, 43cm

Variants: 8 Fr., 6 degree, 43cm, Non-Sterile

Model / REF:

27011L

UDI:

04048551231371

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 9.5 Fr., 6 degree, 43 cm

Variants: 9.5 Fr., 6 degree, 43 cm, Non-Sterile

Model / REF:

27002L

UDI:

04048551231265

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 7 Fr., 34 cm

Variants: 7 Fr., 34 cm, Non-Sterile

Model / REF:

27010K

UDI:

04048551231319

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 7 Fr., 6 degree, 34 cm

Variants: 7 Fr., 6 degree, 34 cm, Non-Sterile

Model / REF:

27000K

UDI:

04048551310816

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 9.5 Fr., 6 degree, 34 cm

Variants: 9.5 Fr., 6 degree, 34 cm, Non-Sterile

Model / REF:

27001K

UDI:

04048551231227

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 9.5 Fr., 6 degree, 34 cm (Model 27002K)

Variants: 9.5 Fr., 6 degree, 34 cm, Non-Sterile

Model / REF:

27002K

UDI:

04048551231227

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 8 Fr., 6 degree, 34cm

Variants: 8 Fr., 6 degree, 34cm

Model / REF:

27011K

UDI:

04048551231357

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95975

Status: Active

Manufacturer: Karl Storz Endoscopy

Sold By: Authorized Medical Distributors

Manufactured In: United States

Units Affected: 14 products (4 Units; 221 units; 185 units; 39 units; 1510 units; 65 units; 59 units; 5 units; 102 units; 3069 Units; 82 units; 185 units; 180 units; 299 units)

Distributed To: Nationwide

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

This recall affects Karl Storz Michel Uretero-Renoscopes, Cysto-Urethroscopes, and various pediatric and standard Uretero-Renoscope models.

Identify if your device is affected by checking the model (REF) numbers, which include 27003L, 27030KA, 27030KB, 27002KP, 27010L, 27000L, 27001L, 27011L, 27002L, 27010K, 27000K, 27001K, 27002K, and 27011K. See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices if you are unable to follow currently validated and approved sterilization protocols.

Contact Karl Storz Endoscopy or your authorized medical distributor to arrange for a device return, replacement, or to receive corrected reprocessing instructions.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this medical device recall.

Affected Products

Product: KARL STORZ - ENDOSKOPE MICHEL Uretero-Renoscope, 9.5 Fr., 43cm

Variants: 9.5 Fr., 43cm

Model / REF:

27003L

UDI:

04048551231296

RxONLY

Product: KARL STORZ - ENDOSKOPE Cysto-Urethroscope

Variants: Non-Sterile

Model / REF:

27030KA

UDI:

04048551232095

Product: KARL STORZ - ENDOSKOPE Pediatric Cysto-Urethroscope

Variants: Non-Sterile

Model / REF:

27030KB

UDI:

04048551232118

Product: KARL STORZ - ENDOSKOPE Pediatric Uretero-Renoscope

Variants: 7.3 Fr., Non-Sterile

Model / REF:

27002KP

UDI:

04048551231234

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 7 Fr., 43cm

Variants: 7 Fr., 43cm, Non-Sterile

Model / REF:

27010L

UDI:

04048551231333

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 7 Fr., 6 degree, 43 cm

Variants: 7 Fr., 6 degree, 43 cm, Non-Sterile

Model / REF:

27000L

UDI:

04048551311271

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 8 Fr., 6 degree, 43 cm

Variants: 8 Fr., 6 degree, 43 cm, Non-Sterile

Model / REF:

27001L

UDI:

04048551231210

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 8 Fr., 6 degree, 43cm

Variants: 8 Fr., 6 degree, 43cm, Non-Sterile

Model / REF:

27011L

UDI:

04048551231371

RxONLY

Product: KARL STORZ - ENDOSKOPE Uretero-Renoscope, 9.5 Fr., 6 degree, 43 cm

Variants: 9.5 Fr., 6 degree, 43 cm, Non-Sterile

Model / REF:

27002L

UDI:

04048551231265

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 7 Fr., 34 cm

Variants: 7 Fr., 34 cm, Non-Sterile

Model / REF:

27010K

UDI:

04048551231319

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 7 Fr., 6 degree, 34 cm

Variants: 7 Fr., 6 degree, 34 cm, Non-Sterile

Model / REF:

27000K

UDI:

04048551310816

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 9.5 Fr., 6 degree, 34 cm

Variants: 9.5 Fr., 6 degree, 34 cm, Non-Sterile

Model / REF:

27001K

UDI:

04048551231227

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 9.5 Fr., 6 degree, 34 cm (Model 27002K)

Variants: 9.5 Fr., 6 degree, 34 cm, Non-Sterile

Model / REF:

27002K

UDI:

04048551231227

RxONLY

Product: KARL STORZ - ENDOSKOPE Ureteroscope, 8 Fr., 6 degree, 34cm

Variants: 8 Fr., 6 degree, 34cm

Model / REF:

27011K

UDI:

04048551231357

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95975

Status: Active

Manufacturer: Karl Storz Endoscopy

Sold By: Authorized Medical Distributors

Manufactured In: United States

Units Affected: 14 products (4 Units; 221 units; 185 units; 39 units; 1510 units; 65 units; 59 units; 5 units; 102 units; 3069 Units; 82 units; 185 units; 180 units; 299 units)

Distributed To: Nationwide