Recall Z-3333-2026 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Karl Storz Endoscopy
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.
| Date | Oct 1, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| Reason | Due to incorrect inside packaging label for eyepiece. |
| Root cause | Employee error |
| Action | On 08/12/2026, an "URGENT: MEDICAL DEVICE RECALL" Letter was sent via email informing customers that, KARL STORZ distributed 6 HOPKINS Telescope 30, 4mm REF: 10005BA between November 24, 2025, and December 15, 2025, that contains an optic (eyepiece) that is incorrectly etched with REF: 10005AA, which is a HOPKINS Telescope 0, 4 mm. The optic (eyepiece) inside the packaging is in fact a REF: 10005BA HOPKINS Telescope 30, 4mm, as the outer packaging indicates. Customers are instructed to: 1. Immediately check for impacted serial numbers in inventory and quarantine the incorrectly etched devices |
| Quantity | 6 eyepieces |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945788 | KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES KARL STORZ Endoscopy-America, Inc., Jan 25, 1995 |