FDA recalling firm · 9 enforcement events · 12 product records · 2015–2025 · CA
Cepheid has 9 FDA enforcement events on this register (12 product records) between 2015 and 2025: 9 device; the busiest year was 2025 with 3.
0% of its events are Class I; the most common class is Class II (8). 5 events are listed as ongoing; the recalling firm's address is in CA.
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
15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Cepheid by year initiated.
Questions and answers
How many FDA recalls has Cepheid had?
9 enforcement events (12 product records) on this register, 2015–2025: 9 device.
Are any Cepheid recalls ongoing?
5 events are listed as ongoing in the current openFDA export.
What class are Cepheid recalls?
8 Class II, 1 Class III. 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.