⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-07-08

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Carl Zeiss Meditec AG
Product
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Reason / hazard
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-06-01
Code info
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
Product quantity
13 units
Voluntary mandated
Voluntary: Firm initiated
City
Oberkochen
State
N/A
Country
Germany
Event id
99239
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.