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. 2023 May 19;16:111–122. doi: 10.2147/MDER.S412802

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.