Device recall

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.

FDA recall source

Recall number

Z-3333-2026

Event id

99586

Status

Ongoing

FDA classification

Class II

Recalling firm

Karl Storz Endoscopy

Report date

Oct 7, 2026

Posted

Oct 1, 2026

Initiated

Aug 12, 2026

Center classification date

Sep 30, 2026

Product code

EOB

Device type

Nasopharyngoscope (Flexible Or Rigid)

Reason

Due to incorrect inside packaging label for eyepiece.

Root cause

Employee error

Quantity

6 eyepieces

Code info

Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z

Distribution

U.S. Nationwide distribution in the states of AZ, CA and MO.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K945788

Location

El Segundo, CA, United States