Recall archive / FDA device enforcement
Injection Needle, REF: 25207 — FDA record Z-0571-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Injection Needle, REF: 25207
- 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.
- Classification
- Class II
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 1
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0571-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 04048551085776. All lot numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Arkansas
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Texas
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Oct 24, 2023
- Center classification date
- Dec 18, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.