Class 2 Device Recall Five S 5.3

• Date Initiated by Firm: July 07, 2023
• Date Posted: September 15, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2589-2023
• Recall Event ID: 92796
• 510(K)Number: K212656
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
• Code Information: UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
• Recalling Firm/ Manufacturer: Karl Storz Endoscopy; 2151 E Grand Ave; El Segundo CA 90245-5017
• For Additional Information Contact: Theresa Mussaw; 424-218-8201
• Manufacturer Reason for Recall: Flexible intubation endoscopes sterility assurance can not be confirmed.
• FDA Determined Cause: Process change control
• Action: On August, 4, 2023, Karl Storz Endoscopy issued an Urgent Medical Device Recall Notification via: UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of Material numbers listed above. 2. Pass on this Urgent Medical Device Recall notice to all users of the products listed above and all other persons who need to be aware within your organization. 3. If you have distributed the products listed, please promptly forward this letter to those recipients, and indicate contact details of the recipient on the Customer Reply From. 4. Return the filled Customer Reply Form by Fax or E-Mail to the indicated contact. 5. Get in touch with your KARL STORZ representative to return affected products. 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.)
• Quantity in Commerce: 218 units
• Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = EOQ