Skip to content

Medical device recalls: April 2019

The FDA posted 23 medical device recall records in April 2019, from 11 recall events by 11 companies. 13 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. ICU Medical, Inc. · 1 event, 7 records, 7 Class I
  2. O-Two Medical Technologies, Inc. · 1 event, 3 records, 3 Class I
  3. Roche Diagnostics Corporation · 1 event, 3 records
  4. DePuy Spine, Inc. · 1 event, 2 records
  5. Edwards Lifesciences, LLC · 1 event, 2 records, 2 Class I
  6. Abbott · 1 event, 1 record
  7. Beaver Visitec · 1 event, 1 record
  8. Brainlab AG · 1 event, 1 record, 1 Class I

FDA root cause

  1. Vendor change control · 7
  2. Device Design · 4
  3. Process control · 3
  4. Under Investigation by firm · 2
  5. Software design · 2
  6. Process design · 2
  7. Packaging process control · 1
  8. Labeling design · 1

Class I recalls (13)

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

Class II recalls (10)

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.