HOPKINS recallZ-3333-2026 · Karl Storz Endoscopy · initiated Aug 12, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Karl Storz Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to incorrect inside packaging label for eyepiece.
FDA root cause category: Employee error
What the company is doing
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 for return to Karl Storz. 2. Pass on this Urgent Medical Device Correction to all users of the products listed below (Table 1 and Table 2) and all other persons who need to be aware within your organization. 3. If customers have or may have distributed the products listed, identify and promptly notify those recipients with a copy of this notice and response form. 4. Return the completed Customer Reply Form by E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5. Report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. For questions - email to [email protected].
Recall details
- Recall number
- Z-3333-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 12, 2026
- Posted by the FDA
- Oct 1, 2026
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 6 eyepieces
- Product code
- EOB
- FDA submissions
- K945788
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA and MO.
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.
Code information (models, lots, serial numbers)
Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HOPKINS 10005BAKarl Storz GmbH & Co. KG · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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