Z-1868-2018Class II

RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery

Name: Z-1868-2018 RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery
Creator: Richard Wolf GmbH
Published: 2018-03-11
License: https://open.fda.gov/license/

Richard Wolf GmbH / initiated 2018-03-11 / Terminated

FDA source

Richard Wolf GmbH began a recall of RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery on 2018-03-11. FDA classified it as Class II and gives the reason as "Tube ends may be mixed up". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1868-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-11
Posted: 2018-05-14
Terminated: 2022-03-09
Recalling firm: Richard Wolf GmbH
Product: RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Product code: HIF Insufflator, Laparoscopic
Reason for recall: Tube ends may be mixed up.
FDA root cause: Use error
Action: The firm initiated the recall via an Urgent Safety Information letter on 03/11/2018. The letter identified the affected product and the problem involved. Customers were asked to check the inventory for the affected lot numbers and complete the attached answer form. The firm requested that the recalled product be discarded. All users should be notified of the safety information. The completed answer form should be returned via fax to 07043 354467 or e-mail to [email protected].
Quantity in commerce: 1710 units
Distribution: Worldwide Distribution
Product codes and lots: Lot numbers: 32062417, 32133317

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1868-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14

Product code HIF

K000180Class IITransanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal EndoscopRichard Wolf Medical Instruments Corp. / cleared 2001-03-02

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)