Recall Ledger

HOPKINS Telescope 30¿ recall (Karl Storz Endoscopy)

Medical deviceClass IIOngoing

Summary: Karl Storz Endoscopy is recalling 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.

What is being recalled

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.

Why

Due to incorrect inside packaging label for eyepiece.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S. Nationwide distribution in the states of AZ, CA and MO. (states named: Arizona, California, Missouri)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3333-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedAugust 12, 2026
ReportedOctober 7, 2026
CompanyKarl Storz Endoscopy
Company locationEl Segundo, CA, United States
Initiated byVoluntary: Firm initiated
Quantity6 eyepieces

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