Skip to content

Medical device recalls: August 2021

The FDA posted 10 medical device recall records in August 2021, from 8 recall events by 7 companies. 4 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. Baxter Healthcare Corporation · 2 events, 2 records, 2 Class I
  2. Boston Scientific Corporation · 1 event, 2 records
  3. Exactech, Inc. · 1 event, 2 records
  4. BioMedical Equipment Service Co (BMES) · 1 event, 1 record, 1 Class I
  5. Cardinal Health 200, LLC · 1 event, 1 record, 1 Class I
  6. Qura S.R.L. · 1 event, 1 record
  7. Zeltiq Aesthetics, Inc · 1 event, 1 record

FDA root cause

  1. Software design · 3
  2. Under Investigation by firm · 2
  3. Component change control · 2
  4. Material/Component Contamination · 1
  5. Labeling Change Control · 1
  6. Component design/selection · 1

Class I recalls (4)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (6)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.