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Medical device recalls: May 2019

The FDA posted 205 medical device recall records in May 2019, from 9 recall events by 9 companies. 11 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. Maquet Cardiovascular, LLC · 1 event, 183 records
  2. Boston Scientific Corporation · 1 event, 9 records
  3. Beckman Coulter Inc. · 1 event, 3 records, 3 Class I
  4. Integra LifeSciences Corp. · 1 event, 3 records, 3 Class I
  5. Terumo Medical Corporation · 1 event, 3 records, 3 Class I
  6. Alpha Omega Engineering · 1 event, 1 record, 1 Class I
  7. Edwards Lifesciences, LLC · 1 event, 1 record, 1 Class I
  8. Elekta Limited · 1 event, 1 record

FDA root cause

  1. Device Design · 190
  2. Component design/selection · 9
  3. Software Design Change · 3
  4. Use error · 1
  5. Under Investigation by firm · 1
  6. Labeling design · 1

Class I recalls (11)

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

Class II recalls (194)

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.