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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Karl Storz Endoscopy: Grasping Forceps, Scissors, and Retractors Recalled for Cleaning Safety Concerns

Agency Publication Date: April 3, 2024
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Summary

Karl Storz Endoscopy is recalling approximately 364 surgical instruments, including Grasping Forceps, Optical Scissors, and Uvula Retractors, because there is inadequate evidence that the recommended cleaning and sterilization (reprocessing) instructions are effective. Using instruments that have not been properly sterilized can lead to the transmission of infections or inflammatory reactions between patients. The affected products were distributed nationwide across 25 states and the District of Columbia.

Risk

If these medical devices cannot be properly cleaned and sterilized between uses, they may harbor biological contaminants or pathogens. This poses a risk of cross-contamination and healthcare-associated infections for patients undergoing surgical procedures.

What You Should Do

  1. Check your surgical inventory for Karl Storz Grasping Forceps (REF 11003MB), Optical Scissors (REF 115400S), or Uvula Retractors (REF 723014).
  2. Verify the Unique Device Identifier (UDI) on the product packaging: 04048551050255 for Forceps, 04048551259788 for Scissors, or 04048551193587 for Retractors.
  3. If you identify any of these products, immediately stop using them for surgical procedures and quarantine them to prevent further use.
  4. Contact Karl Storz Endoscopy or your healthcare provider to discuss the safety of these devices and to receive specific instructions regarding the return or replacement of the units.
  5. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and coordination for affected medical devices.

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

Affected Products

Product: Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm
Model / REF:
REF 11003MB
Lot Numbers:
All Lots
Product: Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Model / REF:
REF 115400S
Lot Numbers:
All Lots
Product: Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only
Model / REF:
REF 723014
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94171
Status: Active
Manufacturer: Karl Storz Endoscopy
Sold By: Karl Storz Endoscopy; Authorized Medical Distributors
Manufactured In: United States
Units Affected: 3 products (190 units; 27 units; 147 Units)
Distributed To: Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, New York, Ohio, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia

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 ยท 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.