FDAClass II · Medical device · Recall Z-2649-2026 · Recalled July 8, 2026

Zeiss Intrabeam Spherical Applicator 1 recall — Carl Zeiss Meditec AG

Agency report date: July 8, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Zeiss Intrabeam Spherical Applicator 1
Company / brand: Carl Zeiss Meditec AG
Lot / serial / date codes: 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: 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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Zeiss Intrabeam Spherical Applicator 1 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2649-2026
Brand: All Carl Zeiss Meditec AG recalls
Classification: Class II
Units affected: 13 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Zeiss Intrabeam Spherical Applicator 1 recall status

Companies & origin

Recalling firm location: Oberkochen, N/A, Germany
Firm address: Rudolf-Eber-Str. 11, N/A, N/A

Identifying details (verbatim from the notice)

Product codes / lots: 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: 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.
Firm notified the public via: Letter
FDA event ID: 99239
Recall initiated: June 1, 2026
FDA classified: July 1, 2026
FDA report date: July 8, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 6, 2026 at 6:00 PM UTC.

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