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Medical device recalls: March 2018

The FDA posted 82 medical device recall records in March 2018, from 40 recall events by 29 companies. 6 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. Zimmer Biomet, Inc. · 5 events, 17 records
  2. Siemens Medical Solutions USA, Inc · 4 events, 10 records
  3. Arrow International Inc · 3 events, 11 records
  4. Smiths Medical ASD Inc. · 2 events, 5 records
  5. Getinge US Sales LLC · 2 events, 2 records
  6. Johnson & Johnson Consumer, Inc. · 1 event, 6 records
  7. Becton Dickinson & Company · 1 event, 4 records, 4 Class I
  8. Boston Scientific Corporation · 1 event, 2 records

FDA root cause

  1. Device Design · 23
  2. Labeling mix-ups · 12
  3. Under Investigation by firm · 8
  4. Software design · 8
  5. Process control · 6
  6. Labeling design · 6
  7. Process design · 4
  8. Process change control · 3

Class I recalls (6)

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

Class II recalls (75)

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

Class III recalls (1)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.