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U.S. Department of Health and Human Services

Class 2 Device Recall KARL STORZ HOPKINS/HOPKINS II

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 Class 2 Device Recall KARL STORZ HOPKINS/HOPKINS IIsee related information
Date Initiated by FirmAugust 12, 2026
Date PostedOctober 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3333-2026
Recall Event ID 99586
510(K)NumberK945788 
Product Classification Nasopharyngoscope (flexible or rigid) - Product Code EOB
ProductHOPKINS 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 Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z
FEI Number 3007475226
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information ContactMrs. Kathy Strange
774-284-1736
Manufacturer Reason
for Recall		Due to incorrect inside packaging label for eyepiece.
FDA Determined
Cause 2		Employee error
ActionOn 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 KSEAProductLabeling@karlstorz.com.
Quantity in Commerce6 eyepieces
DistributionU.S. Nationwide distribution in the states of AZ, CA and MO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EOB
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