FDA Device recall Z-0574-2024
Injection Needle, single cvd. 70 degrees, REF: 738750
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Injection Needle, single cvd. 70 degrees, REF: 738750 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-0574-2024 |
| 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, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
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: 738750/04048551195437, 738752/04048551195444, 738756/04048551195451, 738758/04048551195468, 810505/04048551…REF/UDI-DI: 738750/04048551195437, 738752/04048551195444, 738756/04048551195451, 738758/04048551195468, 810505/04048551203842, 810506/04048551001660 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.
Other recalls by Karl Storz Endoscopy
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FDA Device · Class II · 2026-10-07 · Karl Storz Endoscopy - Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1
FDA Device · Class II · 2026-07-29 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
All Karl Storz Endoscopy recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0574-2024%22
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