Karl Storz Endoskope Biopsy Forceps (Karl Storz) – Cleaning Validation Failure (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

Recommended Action

Per FDA guidance

On December 19, 2024, Karl Storz issued a "Urgent: Medical Device Recall" Notification to affected consignees. In addition to informing consignees about the recall, Karl Storz ask consignees to take the following actions: 1. Immediately quarantine and discontinue use of associated part numbers listed. 2. Pass on this Urgent Medical Device Recall Notice to all users of the recalled product and all other persons who need to be aware within your organization. 3. If you have further distributed the recall product, please identify and promptly notify those recipients by providing a copy of the recall notification and response form, or provide KARL STORZ a list of customers who received/may have received the product listed. 4. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5. Contact your KARL STORZ representative or call KARL STORZ Customer Support to return affected product. " Call Customer Support at 800-421-0837 Option 1 to set up an RMA. " Or call your KARL STORZ representative to assist with setting up an RMA. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Distribution

As reported by FDA

AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OR, PA, SC, TX, VA