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Medical device recalls: June 2011

The FDA posted 318 medical device recall records in June 2011, from 128 recall events by 85 companies. 318 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. Computerized Medical Systems Inc · 26 events, 26 records
  2. Biomet, Inc. · 4 events, 59 records
  3. Terumo Cardiovascular Systems Corporation · 4 events, 20 records
  4. Beckman Coulter Inc. · 3 events, 5 records
  5. Becton Dickinson & Co. · 3 events, 4 records
  6. Boston Scientific Corporation · 2 events, 74 records
  7. Vygon Corporation · 2 events, 6 records
  8. Teleflex Medical · 2 events, 5 records

FDA root cause

  1. Device Design · 95
  2. Employee error · 60
  3. Other · 46
  4. Software design · 39
  5. Nonconforming Material/Component · 28
  6. Process control · 10
  7. Pending · 7
  8. Package design/selection · 5

Not yet classified (318)

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.