Irrigation Tubing for KARL STORZ Endomat Select UP210 REF… recallZ-0363-2025 · Karl Storz Endoscopy · initiated Oct 21, 2024
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 improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
FDA root cause category: Labeling design
What the company is doing
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] .
Recall details
- Recall number
- Z-0363-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 21, 2024
- Posted by the FDA
- Nov 12, 2024
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 40 units
- Product code
- NVT
- Distribution
- U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
Product description
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Code information (models, lots, serial numbers)
Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- n.a. 031523-10Karl Storz GmbH & Co. KG · Tubing and tubing/filter fits1 recall0 reports
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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