Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 5, 2020
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.
Tube material of a smaller diameter was used.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Richard Wolf GmbH recalled Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination sys… - a moderate-severity action.
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination sys… was recalled by Richard Wolf GmbH in August 5, 2020. Reason: Tube material of a smaller diameter was used.. Check the official notice for the remedy. Verify recall #Z-2706-2020 with the FDA Devices before acting.
The recall
Richard Wolf GmbH issued this moderate-severity FDA Devices recall-Tube material of a smaller diameter was used..
- Moderate
- severity level
- Class II
- classification
- August 5, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2706-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2706-2020) was formally reported on August 5, 2020, with the manufacturer initiating the action on June 5, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Richard Wolf GmbH is listed as the recalling firm, operating out of Knittlingen, N/A. Federal records list the affected scope as 338 sets.
The documented reason for this recall is: Tube material of a smaller diameter was used. Distribution data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
338 sets
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2706-2020 |
| Date reported | August 5, 2020 |
| Date initiated | June 5, 2020 |
| Recalling firm | Richard Wolf GmbH |
| Firm location | Knittlingen, N/A |
| Affected scope | 338 sets |
| 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), a… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2706-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Richard Wolf GmbH. Units affected: 338 sets.
Why was this product recalled? ▼
Tube material of a smaller diameter was used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2706-2020.
Where was the recalled product distributed? ▼
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)..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2706-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 5, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.