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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97780

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

Open FDA event record

Event summary

Timeline bucket
October 13, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DERMASENSOR INC

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

DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer

Z-0583-2026
Recall number
Z-0583-2026
Initiated
October 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
DERMASENSOR INC
Quantity
343 (9 units affected)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

Code information

Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.

Distribution pattern

US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.