Recall Z-3333-2026— Karl Storz Endoscopy

Name: FDA recall Z-3333-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2026-08-12. It names one FDA 510(k) clearance: K945788. 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..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2026-08-12
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K945788 — KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURESKARL STORZ Endoscopy-America, Inc.·cleared 1995-01-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

Due to incorrect inside packaging label for eyepiece.

Data sourced from openFDA. This site is unofficial and independent of the FDA.