The FDA announced on 2023-10-24 that Karl Storz Endoscopy is recalling Injection Needles and Cannulas because the manual cleaning process efficacy cannot be assured, potentially exposing patients to a higher risk of infection. The agency issued recall number Z-0572-2024 for the voluntary Class II recall.
How to tell if you have it
- Brand: Karl Storz Endoscopy
- Product: Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
- REF/UDI-DI: 27030N/4048551257180, 27182A/4048551081457
- Lot numbers: All lot numbers
- Units affected: 990
The hazard
According to the FDA, the efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery. If used, this defect may expose the patient to a higher risk of infection.
Context
GovInfoNow's records show Karl Storz Endoscopy has had 24 other recalls on record since 2017-10-10. Other recent recalls of similar products include Karl Storz HOPKINS Telescope Recall (2026-08-12), Karl Storz Flexible Hystero-Fiberscope Kits Recall (2026-05-21), and Karl Storz Endoscopy Optical Biopsy Forceps Recall (2024-12-19). Other recent recalls of similar products include Vortex Surgical 25GA Subretinal Injection Cannula Recall (2025-12-16), Medline Convenience Kits Recall (2026-01-07), and Olympus EVIS EXERA III Duodenoscope Recall (2025-10-14).