Table 3.
Number of Complaints, Injuries, and Deaths Associated with Class I Medical Device Recalls from January 2018 to June 2022
| Number of Complaints/Injuries/Deaths | Complaints | Injuries | Deaths |
|---|---|---|---|
| 0 | 23 (12.2%) | 72 (38.1%) | 101 (53.4%) |
| 1–9 | 34 (18.0%) | 29 (15.3%) | 25 (13.2%) |
| 10–99 | 33 (17.5%) | 21 (11.1%) | 5 (2.6%)a |
| ≥100 | 17 (9.0%) | 3 (1.6%) | 0 (0.0%) |
| Not reported | 82 (43.4%) | 64 (33.9%) | 58 (30.7%) |
| Median (IQR) among those reporting data | 8 (1–58) | 0 (0–7) | 0 (0–0) |
Note: aAll had 10–25 deaths.
Abbreviation: IQR, interquartile range.