Karl Storz - Endoskope - REF 723400 - Optical Biopsy and… recallZ-0837-2025 · Karl Storz Endoscopy · initiated Dec 19, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Karl Storz Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
FDA root cause category: Reprocessing Controls
What the company is doing
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.
Recall details
- Recall number
- Z-0837-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 19, 2024
- Posted by the FDA
- Jan 10, 2025
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 285 units
- Product code
- LRC
- Distribution
- US: 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
Product description
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Code information (models, lots, serial numbers)
Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- n.a. 723400Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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