Tube Set for TEM — Class II medical device recall Z-2706-2020
Terminated recall by Richard Wolf GmbH, reported 2020-08-05, distributed in CA. Tube material of a smaller diameter was used.
| Recall number | Z-2706-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard Wolf GmbH, Knittlingen, N/A, Germany |
| Recall initiated | 2020-06-05 |
| Classified | 2020-07-27 |
| Reported by FDA | 2020-08-05 |
| Terminated | 2024-06-28 |
| Distributed | CA |
| Countries outside the US | AT, CA, DE, DK, ES, FR, GB, HK, IS, LT, NL, NO, NZ, SE |
| Quantity | 338 sets |
| Lot numbers | 32324159 |
| Model numbers | 4170.801 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2706-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.