Richard Wolf GmbH: Medical Device Recall in 2020 - (Recall #: Z-2706-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 5, 2020

Date Posted: August 5, 2020

Recall Number: Z-2706-2020

Event ID: 85863

Reason for Recall:

Tube material of a smaller diameter was used.

Status: Terminated

Product Quantity: 338 sets

Code Information:

Lot Number 32324159, Model # 4170.801

Distribution Pattern:

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).

Voluntary or Mandated:

Voluntary: Firm initiated