Z-3333-2026

HOPKINS Telescope 30, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS and HOPKINS II...

Name: Z-3333-2026 HOPKINS Telescope 30, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS and HOPKINS II...
Creator: Karl Storz Endoscopy
Published: 2026-08-12
License: https://open.fda.gov/license/

Karl Storz Endoscopy / initiated 2026-08-12 / Open, Classified

FDA source

Recall record

Recall number: Z-3333-2026
Status: Open, Classified
Initiated: 2026-08-12
Posted: 2026-10-01
Recalling firm: Karl Storz Endoscopy
Product: 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.
Product code: EOB Nasopharyngoscope (Flexible Or Rigid)
Reason for recall: Due to incorrect inside packaging label for eyepiece.
FDA root cause: Employee error
Action: 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].
Quantity in commerce: 6 eyepieces
Distribution: U.S. Nationwide distribution in the states of AZ, CA and MO.
Product codes and lots: Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z

Product code EOB

K945788Class IIKarl Storz Rigid Telescopes for ENT Endoscopic ProceduresKARL STORZ Endoscopy-America, Inc. / cleared 1995-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)