Richard Wolf Recalls Tube Set for Transanal Endoscopic Microsurgery
Richard Wolf GmbH is recalling 338 Tube Sets for TEM because smaller diameter tube material was used. The affected units were distributed internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations, and the defect is a manufacturing deviation without explicit high-risk pathogen or structural failure implications.
Plain-English summary
Richard Wolf GmbH is recalling 338 sets of the Tube Set for TEM (Model # 4170.801, Lot Number 32324159). The recall is due to the use of tube material with a smaller diameter than intended.
The affected products 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. The recall covers units distributed internationally in Austria, Canada, Germany, Denmark, Spain, France, the United Kingdom, Hong Kong, Iceland, Lithuania, Norway, New Zealand, Sweden, and the Netherlands.
Healthcare providers and patients should stop using the affected Tube Sets and contact Richard Wolf GmbH for further instructions.
The recalled product
- 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 u
- Manufacturer
- Richard Wolf GmbH
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 338
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 32324159
- Model # 4170.801
Distribution
Distribution scope not specified by the agency.
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