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KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL… recallZ-1051-2025 · Karl Storz Endoscopy · initiated Dec 19, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDA root cause category: Labeling Change Control

What the company is doing

On December 19, 2024, Karl Storz, issued an "Urgent: Medical Device Correction" notification to affected consignees via UPS. In addition to informing consignees about the recall, Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at the following link: https://www.karlstorz.com/de/en/eifu.htm?q=&country=US 3. Pass on this Urgent Medical Device Correction to all users of the recalled products and all other persons who need to be aware within your organization. 4. If you have or may have distributed the products listed, please identify and promptly notify those recipients with a copy of this notice, response form and updated e-IFU. 5. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 6. Please 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. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Recall details

Recall number
Z-1051-2025
Status
Open, Classified
Initiated by the company
Dec 19, 2024
Posted by the FDA
Jan 30, 2025
Recalling firm
Karl Storz Endoscopy
Quantity
4 Units
Product code
FGB
FDA submissions
K233372
Distribution
US Nationwide distribution.

Product description

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

Code information (models, lots, serial numbers)

All Lots/UDI: 04048551231296

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95975).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page