FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
- Recall number
- Z-1053-2025
- Recalling firm
- Karl Storz Endoscopy
- Product
- KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
- Status
- Open, Classified
- Initiated
- 2024-12-19
- Posted
- 2025-01-30
- Terminated
- not on file
- Reason
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Root cause
- Labeling Change Control
- Action
- 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.
- Quantity
- 185 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All Lots/UDI: 04048551232118
- 510(k) numbers
- ["K233372"]
- PMA numbers
- not on file
- Product code
- FGB
- 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