CLASS II Device recall · Reported 5 Aug 2020 · FDA Enforcement Report
Tube Set for TEM recalled by Richard Wolf
Richard Wolf is recalling Tube Set for TEM, distributed nationwide in the US. The recall was initiated on 5 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2706-2020
- FDA event ID
- 85863
- Recalling firm
- Richard Wolf, Knittlingen, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2020
- FDA classified
- 27 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 5 Jun 2020 | Recall initiated by company | |
| 27 Jul 2020 | Classified by FDA | +52 days |
| 5 Aug 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tube material of a smaller diameter was used.
Product as listed by the FDA
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.
Where it was distributed
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).
Questions about this recall
Is Tube Set for TEM recalled?
Yes. Richard Wolf recalled Tube Set for TEM on 5 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2706-2020.
Why was it recalled?
Tube material of a smaller diameter was used.
Which lots are affected?
Lot Number 32324159, Model # 4170.801
Where was it sold?
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).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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