Z-1063-2025Class II
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy-America, Inc. / initiated 2024-12-19 / Open, Classified / root cause: labeling and UDI
Karl Storz Endoscopy began a recall of KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 on . FDA classified it as Class II and gives the reason as "Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1063-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Karl Storz Endoscopy-America, Inc.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123
- Product code
- FGB Ureteroscope And Accessories, Flexible/Rigid
- Reason for recall
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Root cause tag
- labeling and UDI
- 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 in commerce
- 180 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- All Lots/UDI:04048551231227
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1051-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1052-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1053-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1054-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1055-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1056-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1057-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1058-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1059-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1060-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1061-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1062-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1063-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1064-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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