Lower riskMedical device recall · FDA · Published June 5, 2020
Richard Wolf Tube Set for TEM: Small Diameter Tube Material Hazard
Richard Wolf recalls TEM Tube Sets with small diameter tube material that may cause improper use during transanal endoscopic procedures. Affected units include Lot 32324159, Model 4170.801.
“Richard Wolf Tube Set for TEM: Small Diameter Tube Material Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65030-richard-wolf-tube-set-for-tem-small-diameter-tube-material. Based on FDA recall #Z-2706-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2706-2020%22&limit=1).
Richard Wolf GmbH voluntarily recalled the Tube Set for Transanal Endoscopic Microsurgery (TEM) combination system on June 5, 2020, according to the FDA. The agency stated the recall was due to the use of a tube material with a smaller diameter than specified.
How to tell if you have it
Brand: Richard Wolf
Product: Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set
Model #: 4170.801
Lot Number: 32324159
The hazard
The recall was issued because a tube material of a smaller diameter was used in the product.
Context
GovInfoNow's records show Richard Wolf GmbH has had six other recalls on record since July 24, 2017. Other recent recalls include the PiezoWave 2 Control Unit Recall (April 9, 2025), the FLEX GRASP FORCEPS 5FR WL 550MM recall (March 24, 2023), and the Cutting Electrode BIPO 24.5FR recall (June 25, 2021). Other recent recalls of similar products include the Fletcher CT/MR Shielded Applicator Set Recall (April 3, 2026), the SEDIPLAST Diagnostic Tubes recall (August 25, 2026), and the Geneva Brachytherapy Applicator Recall (April 3, 2026).
How to tell if you have this one
Check for Lot Number 32324159 and Model # 4170.801 on the tube set packaging. The product is designed for transanal endoscopic microsurgery procedures.
Brand
Richard Wolf
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for Lot Number 32324159 and Model # 4170.801 on the tube set packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 4.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2706-2020 (June 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2706-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.