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Medical device recalls: October 2007

The FDA posted 77 medical device recall records in October 2007, from 41 recall events by 36 companies. 77 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. Becton Dickinson & Company · 2 events, 5 records
  2. Boston Scientific Corporation · 2 events, 4 records
  3. Biomet, Inc. · 2 events, 3 records
  4. Medtronic Neuromodulation · 2 events, 2 records
  5. Pml Microbiologicals Inc. · 2 events, 2 records
  6. Smith & Nephew Inc · 1 event, 18 records
  7. Medtronic Inc. Cardiac Rhythm Managment · 1 event, 4 records
  8. Olympus America Inc. · 1 event, 4 records

FDA root cause

  1. Packaging process control · 19
  2. Process control · 14
  3. Device Design · 11
  4. Process design · 10
  5. Software design · 6
  6. Packaging change control · 2
  7. Package design/selection · 2
  8. Labeling mix-ups · 2

Not yet classified (77)

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.