FDA recall, , Moderate risk
Sysmex America TS-10/TS-10H Tube Sorter
The TS-10/TS-10H Tube Sorter may unexpectedly disengage its lift, causing unintended downward movement.
Summary by Recall Canary from the FDA notice
What happened
Sysmex America, Inc., of Lincolnshire, Illinois, recalled its TS-10/TS-10H Tube Sorter, an automatic sorting system for sorting barcoded sample tubes, running software versions 00-17. The FDA stated that, under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. The recall began December 15, 2025, and was added to the FDA's Enforcement Report on January 21, 2026.
The recalled units were distributed US Nationwide. The FDA classified the recall on January 21, 2026, and it was in the FDA's weekly enforcement report on January 28, 2026.
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 your tube affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Sysmex America, Inc.Lincolnshire, Illinois
- 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
- 98213
- Recall number
- Z-1136-2026
- Quantity recalled
- 44 units
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
In FDA's weekly enforcement report
Listed on Recall Canary
