Injection Needle, REF: 25207
FDA Recall Z-0571-2024 · Posted 2023-12-18
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Recalling FirmKarl Storz Endoscopy
Recall StatusOpen, Classified
Product CodeGCF
Date Initiated2023-10-24
Product Quantity1
Reason for Recall
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.
Firm 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 [email protected]
For all other questions regarding this communication, please send an email to [email protected]
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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