Z-0363-2025Class II

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Name: Z-0363-2025 Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Creator: Karl Storz Endoscopy
Published: 2024-10-21
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2024-10-21 / Open, Classified / root cause: labeling and UDI

FDA source

Karl Storz Endoscopy began a recall of Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC on 2024-10-21. FDA classified it as Class II and gives the reason as "Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0363-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-21
Posted: 2024-11-12
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Product code: NVT Tubing And Tubing/Filter Fits
Reason for recall: Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 10/22/2024, an "URGENT: MEDICAL DEVICE CORRECTION" Letters will be sent via email by KARL STORZ informing customers that the firm has become aware that one lot number of misbranded product was distributed to 19 customers. Customers are instructed to: 1. Pass on this Urgent Medical Device Correction to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. 2. Communicate to all applicable users that the product is not to be utilized during spinal procedures. 3. If you have or may have distributed the products listed, please identify and promptly notify those recipients of this notice. 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. 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. for questions send an email to [email protected] .
Quantity in commerce: 40 units
Distribution: U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
Product codes and lots: Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0363-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0363-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12

Product code NVT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)