FDA Device recall Z-0575-2024
Injection Needle, curved 23 cm, REF: 8598A
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Injection Needle, curved 23 cm, REF: 8598A by Karl Storz Endoscopy, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0575-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-24 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | AK, AR, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV |
Product
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
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.
Identifiers
| code_info | REF/UDI-DI: 8598A/04048551213278, 8598B/04048551001462, 8598D/04048551213285 All lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0575-2024%22
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