FDA recall, , Moderate risk
Beckman Coulter Rotor SW40 and SW41
Beckman Coulter Rotor SW40 and SW41 may break into two or more pieces.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc. is recalling the Rotor Assy-SW41 and Rotor Assy-SW40, which are used in Optima XPN and Optima XE centrifuges. The Rotor Assy-SW41 has been found with a non-conforming microstructure, which may result in the rotor breaking into two or more pieces during use, potentially causing significant damage to samples and the centrifuge instrument.
The Rotor Assy-SW40 may contain a microstructure defect that can cause it to break into two or more pieces during a centrifugation run, resulting in destruction of samples and, when used for in vitro diagnostic sample preparation, may delay patient test results and expose laboratory personnel to biohazardous materials.
The recall began on September 21, 2026, and was added to the FDA's Enforcement Report on October 21, 2026, with nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Rotor Assy-SW41
Reason: Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use.
Rest of the reason
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.
- UDI-DI
- 15099590416324
- 15099590415754
- 15099590415822
- 15099590415846
- 15099590415860
- Reference number
- 331362
- Installed in
- Optima XPN-100 (A99846, A94469), Optima XPN-90 (A99842, A94468), Optima XPN-80 (A99839, A95765), Optima XE-100 (A99836, A94516), Optima XE-90 (A99833, A94471)
Rotor Assy-SW40
Reason: Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed.
Rest of the reason
When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to biohazardous materials.
- UDI-DI
- 15099590416324
- 15099590415754
- 15099590415822
- 15099590415846
- 15099590415860
- Reference number
- 331302
- Installed in
- Optima XPN-100 (A99846, A94469), Optima XPN-90 (A99842, A94468), Optima XPN-80 (A99839, A95765), Optima XE-100 (A99836, A94516), Optima XE-90 (A99833, A94471)
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Beckman Coulter, Inc.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99882
- Recall numbers
- Z-0201-2027 to Z-0202-2027
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
