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Medical device recalls: September 2006

The FDA posted 87 medical device recall records in September 2006, from 48 recall events by 43 companies. 87 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. Boston Scientific · 2 events, 5 records
  2. Becton Dickinson & Company · 2 events, 4 records
  3. Invacare Corporation · 2 events, 4 records
  4. Medtronic Neurological · 2 events, 4 records
  5. Kerr Corp · 2 events, 2 records
  6. Boston Scientific CRM Corp · 1 event, 7 records
  7. Pointe Scientific, Inc. · 1 event, 7 records
  8. Cobe Cardiovascular, Inc · 1 event, 4 records

FDA root cause

  1. Other · 83
  2. Software design · 2
  3. Package design/selection · 1
  4. Device Design · 1

Not yet classified (87)

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.