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Medical device recalls: April 2009

The FDA posted 137 medical device recall records in April 2009, from 52 recall events by 41 companies. 137 have not been classified yet.

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. Abbott Laboratories · 3 events, 8 records
  2. GE Medical Systems, LLC · 3 events, 8 records
  3. Pointe Scientific, Inc. · 2 events, 3 records
  4. Smiths Medical MD, Inc. · 2 events, 3 records
  5. Stryker Howmedica Osteonics Corp. · 2 events, 3 records
  6. Biomet, Inc. · 2 events, 2 records
  7. DiaDexus, Inc · 2 events, 2 records
  8. Immuno Concepts Inc · 2 events, 2 records

FDA root cause

  1. Process control · 39
  2. Process design · 32
  3. Software design · 16
  4. Device Design · 11
  5. Other · 9
  6. Packaging process control · 6
  7. Labeling design · 6
  8. Employee error · 6

Not yet classified (137)

The FDA has posted these records but has not published a class for them yet.

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.