Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany
Lot Codes / Batch Numbers
Lot Number 32324159, Model # 4170.801
Products Sold
Lot Number 32324159, Model # 4170.801
Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany is recalling Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the due to Tube material of a smaller diameter was used.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tube material of a smaller diameter was used.
Recommended Action
Per FDA guidance
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 vigilance@richard-wolf.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, DE, IN
Page updated: Jan 10, 2026