# FDA recall Z-2706-2020

> **Richard Wolf GmbH** · Class II · device recall initiated 2020-06-05.

## 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 under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.

## Reason for recall

Tube material of a smaller diameter was used.

## Distribution

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).

## Key facts

- **Recall number:** Z-2706-2020
- **Recalling firm:** Richard Wolf GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-05
- **Report date:** 2020-08-05
- **Termination date:** 2024-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Knittlingen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2706-2020

## Citation

> AI Analytics. FDA recall Z-2706-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2706-2020. Source: US FDA. Licensed CC0.

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