Z-0716-2025Class I

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube

Name: Z-0716-2025 Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube
Creator: Trokamed GmbH
Published: 2024-11-27
License: https://open.fda.gov/license/

Trokamed GmbH / initiated 2024-11-27 / Open, Classified / root cause: labeling and UDI

FDA source

Trokamed GmbH began a recall of Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube on 2024-11-27. FDA classified it as Class I and gives the reason as "If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure". 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-0716-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-11-27
Posted: 2025-01-10
Recalling firm: Trokamed GmbH
Product: Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Product code: FED Endoscopic Access Overtube, Gastroenterology-Urology
Reason for recall: If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On November 27, 2024, a "URGENT SAFETY FIELD NOTICE" email was sent to the distributor. Actions to be taken: - Inform the medical personnel using the product about the update of the IFU: 1. The Instructions for Use has to be exchanged. 2. Complete the enclosed acknowledgement of receipt and email to [email protected] by the provided date. - Please be informed that the assumption of risks is on your behalf when you will not send back the acknowledgement by the provided date. Disclosure of the information described herein: Please ensure in your organization that all users of the above-mentioned products and other persons to be informed are made aware of this Urgent Field Safety Notice. If you have given the products to third parties, please forward a copy of this information or inform the contact person indicated below. Please keep this information at least until the action has been completed. If you have any questions or concerns about this notification, please contact the Quality Management Representative at +49 7704 9244 60. ***Updated 2/5/2025*** On 01/14/2025 an updated "URGENT SAFETY FIELD NOTICE" letter was sent to their distributor account. What measures are to be taken by the recipient? 1. Inform the medical personnel using the product about this field safety notice. 2. Replace your current Instructions for Use for this device with the updated version provided (W9229406_01). This is not a product removal action. You may continue to use the device as per this letter and the updated Instruction for Use. 3. Acknowledge receipt according to the instructions provided by your local distributor. Please ensure in your organization that all users of the above-mentioned products and other persons to be informed are made aware of this Urgent Field Safety Notice. If you have given the products to third parties, please forward a copy of this information or inform the contact person indicated below. Please keep this information at least until the action has been
Quantity in commerce: 102 units
Distribution: US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Product codes and lots: REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0713-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0714-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0715-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0716-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code FED

K200770Class IIMini PCNL-SystemTrokamed GmbH / cleared 2021-07-30

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)