CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report

Tube Set For Tem recalled by Richard Wolf

Richard Wolf is recalling Tube Set For Tem. The recall was initiated on 11 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 32062417, 32133317

Quantity recalled1710 units

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-1868-2018
FDA event ID: 79886
Recalling firm: Richard Wolf, Knittlingen
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2018
FDA classified: 14 May 2018
Reported: 23 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

11 Mar 2018	Recall initiated by company
14 May 2018	Classified by FDA	+64 days
23 May 2018	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 ends may be mixed up.

Product as listed by the FDA

RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

Where it was distributed

Worldwide Distribution

Questions about this recall

Why was it recalled?

Tube ends may be mixed up.

Which lots are affected?

Lot numbers: 32062417, 32133317

Where was it sold?

Worldwide Distribution

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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