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 in California. The recall was initiated on 5 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 32324159, Model # 4170.801

Quantity recalled338 sets

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).

California

Questions about this recall

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?

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 26 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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