Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80970

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 06, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Dannoritzer Medizintechnik GmbH & Co. KG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0062-2019
Recall number
Z-0062-2019
Initiated
August 06, 2018
Classification
Class III
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

none

Distribution pattern

US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.