Root causes

Why devices get recalled

Every recall carries an FDA root-cause determination. Grouped here into failure families — bar length shows how common each cause is; colors show its severity mix.

Design & Components

1,351 recalls

Device DesignThe recall stems from how the device itself was designed, rather than a manufacturing mistake.
620
Nonconforming Material/ComponentA material or component in the device did not meet its specification.
426
Process design
95
Component design/selectionA specific component was the wrong choice or failed in the field.
88
Material/Component Contamination
63
Component change control
49
Mixed-up of materials/components
10

Software

372 recalls

Software designA flaw in the device's software — logic, interface, or update — triggered the recall.
278
Software Design Change
44
Software change control
36
Software design (manufacturing process)
14

Process & Manufacturing

1,174 recalls

Process controlSomething drifted in the manufacturing process that quality controls did not catch in time.
853
Process change control
212
Storage
39
Equipment maintenance
38
Employee error
32

Packaging

151 recalls

Package design/selectionPackaging failed to protect the product — sterility breaches and shipping damage live here.
68
Packaging change control
37
Packaging process control
29
Packaging
17

Labeling

198 recalls

Labeling Change ControlThe label, instructions, or markings were wrong or out of date.
78
Labeling design
49
Incorrect or no expiration date
33
Error in labeling
22
Labeling mix-ups
16

Administrative & Other

1,645 recalls

Under Investigation by firmThe manufacturer has not yet reported a final root cause; the investigation is still open.
1,228
No Marketing Application
229
Other
61
Radiation Control for Health and Safety Act
53
Use error
48
Unknown/Undetermined by firm
26

Families group the FDA's 6 root-cause determinations for scanability; each links to its full recall list. Source: U.S. FDA openFDA + RES records.