Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery Recalled by Richard Wolf GmbH Due to Tube material of a smaller diameter was used.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Richard Wolf GmbH directly.
Affected Products
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.
Quantity: 338 sets
Why Was This Recalled?
Tube material of a smaller diameter was used.
Where Was This Sold?
This product was distributed to 2 states: CA, DE
About Richard Wolf GmbH
Richard Wolf GmbH has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report