Beckman Coulter, Inc.: Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

Beckman Coulter is recalling certain SW41 rotors used in five models of Optima centrifuges due to defects in the rotor material that can cause them to break apart during operation. When rotors break, they can damage both the samples being processed and the centrifuge machine itself. The affected rotors were distributed nationwide across all US states.

Recalling firm
Beckman Coulter, Inc.
Product
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)
Reason
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.
Classification
Class I
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-09-21
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/33f8c986-97d3-427d-84d7-8e2e8337e13d