FDA recalling firm · 12 enforcement events · 14 product records · 2012–2025 · IL
Sysmex America, Inc. has 12 FDA enforcement events on this register (14 product records) between 2012 and 2025: 12 device; the busiest year was 2020 with 3.
0% of its events are Class I; the most common class is Class II (12). 2 events are listed as ongoing; the recalling firm's address is in IL.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
12
14
16
18
20
22
24
26
Enforcement events for Sysmex America, Inc. by year initiated.
Questions and answers
How many FDA recalls has Sysmex America, Inc. had?
12 enforcement events (14 product records) on this register, 2012–2025: 12 device.
Are any Sysmex America, Inc. recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are Sysmex America, Inc. recalls?
12 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.