HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes ar
Summary
The FDA issued a Class II for HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STOR by Karl Storz Endoscopy. Reason: Due to incorrect inside packaging label for eyepiece..
Details
Source
Device Recall
External ID
Z-3333-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
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.
Lot/Code Info: Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z
Quantity Affected: 6 eyepieces
Reason for Recall
Due to incorrect inside packaging label for eyepiece.
Distribution
U.S. Nationwide distribution in the states of AZ, CA and MO.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-12
Company
El Segundo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Karl Storz Endoscopy has 54 FDA actions in our database, including 54 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Karl Storz Endoscopy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Karl Storz Endoscopy have FDA actions?
Karl Storz Endoscopy has 54 FDA actions in our database, including 54 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3333-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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