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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95880

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 15, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Mint Medical GmbH

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

2 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 2

mint Lesion, Software Versions: 3.9.0 through 3.9.5.

Z-0709-2025
Recall number
Z-0709-2025
Initiated
November 15, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Mint Medical GmbH
Quantity
65 units (13 US, 52 OUS)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software versions have a malfunction where they may show incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Code information

Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;

Distribution pattern

Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.

device · product 2 of 2

mint Lesion, Software Versions: 3.10.0 and 3.10.1.

Z-0710-2025
Recall number
Z-0710-2025
Initiated
November 15, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Mint Medical GmbH
Quantity
18 units (7 US, 11 OUS)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software versions have a malfunction where they may show incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Code information

Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;

Distribution pattern

Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.