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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79908

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

Open FDA event record

Event summary

Timeline bucket
February 26, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Beaver-Visitec International 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

WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.

Z-1539-2018
Recall number
Z-1539-2018
Initiated
February 26, 2018
Classification
Class II
Status
Terminated
Quantity
110 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.

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

Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.

Code information

Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899

Distribution pattern

Distributed to the states of OH, NY, FL, MN, and KS.

Field note

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