FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: Injection Needle, REF: 25207
- Recall number
- Z-0571-2024
- Recalling firm
- Karl Storz Endoscopy
- Product
- Injection Needle, REF: 25207
- Status
- Open, Classified
- Initiated
- 2023-10-24
- Posted
- 2023-12-18
- Terminated
- not on file
- Reason
- The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
- Root cause
- Device Design
- Action
- On 10/24/23, recall notices were mailed to representatives for medical product safety, users, operators, distributors who were asked to do the following: 1) Discontinue use of all affected Injection Needles. 2) Pass on the Recall Notice to all users of the affected products 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 the recalling firm with a list of customers who received/may have received the products listed. 4) Contact Customer Support to arrange for the return of affected devices by calling 800-421-0837. 5) Return the completed Customer Reply Form via email to karlstorz5190@sedgwick.com For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com
- Quantity
- 1
- Distribution
- US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, Germany
- Lot, serial or model codes
- UDI-DI: 04048551085776. All lot numbers
- 510(k) numbers
- ["K945209"]
- PMA numbers
- not on file
- Product code
- GCF
- 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