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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 99239

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

Open FDA event record

Event summary

Timeline bucket
June 01, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Carl Zeiss Meditec AG

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

Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Z-2649-2026
Recall number
Z-2649-2026
Initiated
June 01, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Carl Zeiss Meditec AG
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

Code information

UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313

Distribution pattern

Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.