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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 8, 2026

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

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Identifiers to compare

  • Serial numbers
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A631313 unitsZ-2649-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.