FDA Device recall Z-3333-2026
HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visual…
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visual… by Karl Storz Endoscopy, citing due to incorrect inside packaging label for eyepiece.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3333-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-12 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
Product
HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.
Reason
Due to incorrect inside packaging label for eyepiece.
Identifiers
| code_info | Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by 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 - KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
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-3333-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.