Z-0571-2024Class II

Injection Needle, REF: 25207

Name: Z-0571-2024 Injection Needle, REF: 25207
Creator: Karl Storz Endoscopy
Published: 2023-10-24
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2023-10-24 / Open, Classified / root cause: design

FDA source

Karl Storz Endoscopy began a recall of Injection Needle, REF: 25207 on 2023-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0571-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-24
Posted: 2023-12-18
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Injection Needle, REF: 25207
Product code: GCF Proctoscope
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.
Root cause tag: design
FDA 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 [email protected] For all other questions regarding this communication, please send an email to [email protected]
Quantity in commerce: 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
Product codes and lots: UDI-DI: 04048551085776. All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0571-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0571-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-18
Z-0572-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-18
Z-0573-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-18
Z-0574-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-18
Z-0575-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-18

Product code GCF

K945209Class IIProctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology InstrumentsKARL STORZ Endoscopy-America, Inc. / cleared 1995-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)