Sysmex America recalls

Sysmex America has 14 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 28 Jan 2026. 2 are still ongoing. 1 was reported in the last 12 months.

Total recalls14since 2012

Last 12 months1reported

Class I00% of total

Ongoing2latest 28 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 1 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 1Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 14 100%Class III 0 0%

Why sysmex america is recalled

Other Reasons857%
Device Malfunction643%

Product types

By year

202617%
202517%
2020321%
201817%
2017214%
201617%
201417%
201317%
2012321%

Ongoing sysmex america recalls

2 active

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	TS-10/TS-10H Tube Sorter, automatic sorting system recalled	Sysmex America	Device Malfunction	Nationwide
12 Feb 2025Device	CLASS II	Sysmex PS-10 Sample Preparation System recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide

All sysmex america recalls, newest first

14 total

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	TS-10/TS-10H Tube Sorter, automatic sorting system recalled	Sysmex America	Device Malfunction	Nationwide
12 Feb 2025Device	CLASS II	Sysmex PS-10 Sample Preparation System recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
29 Jul 2020Device	CLASS II	Sysmex PS-10 Sample Preparation System recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
22 Apr 2020Device	CLASS II	The CF-70 instrument (product recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
22 Apr 2020Device	CLASS II	Sysmex CV-11 Sample Unit, an integrated modular sampler recalled	Sysmex America	Other	FL, IL, VT
5 Sep 2018Device	CLASS II	Sysmex XN-Series Fluorocell PLT recalled by Sysmex America	Sysmex America	Other	Nationwide
1 Nov 2017Device	CLASS II	Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain recalled	Sysmex America	Other	Nationwide
10 May 2017Device	CLASS II	Sysmex, Automated Hematology Analyzer XN Series recalled	Sysmex America	Device Malfunction	Nationwide
21 Sep 2016Device	CLASS II	Fluorocell PLT reagent recalled by Sysmex America	Sysmex America	Other	Nationwide
19 Feb 2014Device	CLASS II	The UF-1000i is a fully automated urine particle analyzer recalled	Sysmex America	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.