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

1,243 recalls

Device DesignThe recall stems from how the device itself was designed, rather than a manufacturing mistake.
588
Nonconforming Material/ComponentA material or component in the device did not meet its specification.
386
Process design
86
Component design/selectionA specific component was the wrong choice or failed in the field.
82
Component change control
48
Material/Component Contamination
43
Mixed-up of materials/components
10

Software

335 recalls

Software designA flaw in the device's software — logic, interface, or update — triggered the recall.
262
Software change control
35
Software Design Change
27
Software design (manufacturing process)
11

Process & Manufacturing

1,105 recalls

Process controlSomething drifted in the manufacturing process that quality controls did not catch in time.
816
Process change control
185
Storage
39
Equipment maintenance
33
Employee error
32

Packaging

147 recalls

Package design/selectionPackaging failed to protect the product — sterility breaches and shipping damage live here.
68
Packaging change control
36
Packaging process control
28
Packaging
15

Labeling

174 recalls

Labeling Change ControlThe label, instructions, or markings were wrong or out of date.
66
Labeling design
47
Incorrect or no expiration date
25
Error in labeling
22
Labeling mix-ups
14

Administrative & Other

1,522 recalls

Under Investigation by firmThe manufacturer has not yet reported a final root cause; the investigation is still open.
1,121
No Marketing Application
228
Other
61
Radiation Control for Health and Safety Act
45
Use error
44
Unknown/Undetermined by firm
23

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.