FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
- Recall number
- Z-1473-2024
- Recalling firm
- Karl Storz Endoscopy
- Product
- Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
- Status
- Open, Classified
- Initiated
- 2024-02-27
- Posted
- 2024-04-03
- Terminated
- not on file
- Reason
- Inadequate reprocessing validation evidence
- Root cause
- Under Investigation by firm
- Action
- On March 4, 2024, Karl Storz issued a "Urgent: Medical Device Recall" via UPS. Karl Storz asked 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 products listed above (Table 1) and all other persons who need to be aware within your organization. 3. If you have or may have distributed the products listed, please identify and promptly notify those recipients, or provide KARL STORZ a list of customers who received/may have received the products 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 products. For Human Product: 5a. Call Customer Support at 800-421-0837 Option 1 to set up an RMA. 5b. Or call your KARL STORZ representative to assist with setting up an RMA. For Veterinary Product: 5c. Call KSVEA Customer Support at 800-955-7832 Option 1 to set up an RMA. 5d. Or email VetCustomerService@karlstorz.com 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
- 27 units
- Distribution
- US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
- Lot, serial or model codes
- UDI: 04048551259788/ All Lots
- 510(k) numbers
- ["K951343"]
- PMA numbers
- not on file
- Product code
- HET
- Firm FEI
- 3007475226
- Firm city
- El Segundo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28