FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
- Recall number
- Z-0363-2025
- Recalling firm
- Karl Storz Endoscopy
- Product
- Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
- Status
- Open, Classified
- Initiated
- 2024-10-21
- Posted
- 2024-11-12
- Terminated
- not on file
- Reason
- 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
- 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 KSEAProductLabeling@karlstorz.com .
- Quantity
- 40 units
- Distribution
- U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
- Lot, serial or model codes
- Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NVT
- Firm FEI
- 3007475226
- Firm city
- El Segundo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28