Z-2706-2020Class II

Tube Set for TEM -

Name: Z-2706-2020 Tube Set for TEM -
Creator: Richard Wolf GmbH
Published: 2020-06-05
License: https://open.fda.gov/license/

Richard Wolf GmbH / initiated 2020-06-05 / Terminated / root cause: manufacturing process

FDA source

Richard Wolf GmbH began a recall of Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to... on 2020-06-05. FDA classified it as Class II and gives the reason as "Tube material of a smaller diameter was used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2706-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-05
Posted: 2020-07-27
Terminated: 2024-06-28
Recalling firm: Richard Wolf GmbH
Product: Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
Product code: HIF Insufflator, Laparoscopic
Reason for recall: Tube material of a smaller diameter was used.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent a letter to its consignees on June 5, 2020 indicating their customers the following: Please read this letter as well as the reference documents (see list of appendices) completely and keep them until this measure is completed. Please carry out the following steps: 1. Check your stock for TEM tube sets 4170801 of the lot affected (lot no. 32324159). The sets with the faulty pump tubes shall be blocked for any further use and then discarded and the disposal shall be documented. 2. Make sure within your organization that all users of the product mentioned above and other per-sons to be informed gain knowledge of this urgent safety information. If the product has been passed on to third parties, please also pass on a copy of this information, and inform the contacts listed below. Make sure that this information is followed in your institution until all necessary in-house measures are completed. 4. To verify receipt of this urgent safety information we need the included answer form which we kindly ask you to return to fax number 07043 351360, or via e-mail to [email protected] by June 26, 2020. Please fill in this form even if the product is no longer in your stock. With the answer form you confirm receipt of this urgent safety information and avoid getting further reminder letters from Richard Wolf. 5. Inform Richard Wolf GmbH about any adverse events.
Quantity in commerce: 338 sets
Distribution: International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL).
Product codes and lots: Lot Number 32324159, Model # 4170.801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2706-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2706-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-27

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)