ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471)

Class II

Recalling firm: Beckman Coulter, Inc.
Reason for recall: Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
Affected products (lot / model / serial): Serial Numbers: 24U15250 to 26U15766; Optima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860
Units affected: 336 units
Distribution pattern: US Nationwide distribution.
Firm location: Indianapolis, IN, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-0202-2027
Recall initiated: September 21, 2026
FDA classification date: October 21, 2026
FDA report date: October 28, 2026
FDA event ID: 99882
Last updated on HTM Vibe: November 3, 2026