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Medical device recalls: May 2008

The FDA posted 78 medical device recall records in May 2008, from 31 recall events by 30 companies. 78 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 · 2 events, 2 records
  2. Ev3, Inc · 1 event, 12 records
  3. Covidien LP · 1 event, 9 records
  4. Beckman Coulter Inc · 1 event, 8 records
  5. Pointe Scientific, Inc. · 1 event, 8 records
  6. Boston Scientific Corporation · 1 event, 6 records
  7. Viasys Respiratory Care, Inc.dba Bird Products · 1 event, 5 records
  8. Medefil Incorporated · 1 event, 3 records

FDA root cause

  1. Software design · 13
  2. Material/Component Contamination · 13
  3. Labeling Change Control · 13
  4. Process control · 11
  5. Labeling mix-ups · 10
  6. Component design/selection · 6
  7. Device Design · 4
  8. Nonconforming Material/Component · 3

Not yet classified (78)

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.