Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Optical Biopsy and Grasping Forceps

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Optical Biopsy and Grasping Forcepssee related information
Date Initiated by FirmDecember 19, 2024
Date PostedJanuary 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0837-2025
Recall Event ID 95954
Product Classification Instrument, ent manual surgical - Product Code LRC
ProductKarl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Code Information Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416
FEI Number 3007475226
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information ContactMrs. Kathy Strange
774-284-1736
Manufacturer Reason
for Recall		Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
FDA Determined
Cause 2		Reprocessing Controls
ActionOn 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.
Quantity in Commerce285 units
DistributionUS: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None
Total Product Life CycleTPLC 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.
-
-