Laparoscopy Instruments Instructions For Use — Class III medical device recall Z-0062-2019
Terminated recall by Dannoritzer Medizintechnik GmbH & Co. KG, reported 2018-10-10, distributed nationwide. The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validat
| Recall number | Z-0062-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dannoritzer Medizintechnik GmbH & Co. KG, Tuttlingen, Germany |
| Recall initiated | 2018-08-06 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2019-07-22 |
| Distributed | Nationwide (US) |
Product
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
Reason for recall
The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.
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-0062-2019. 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.