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Medical device recalls: October 2008

The FDA posted 173 medical device recall records in October 2008, from 65 recall events by 51 companies. 173 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. Siemens Medical Solutions USA, Inc. · 3 events, 4 records
  2. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  3. Stryker Howmedica Osteonics Corp. · 3 events, 3 records
  4. Bard Peripheral Vascular Inc · 2 events, 52 records
  5. Siemens Medical Solutions USA, Inc · 2 events, 12 records
  6. Boston Scientific Corporation · 2 events, 8 records
  7. Pointe Scientific, Inc. · 2 events, 8 records
  8. Roche Diagnostics Corp. · 2 events, 8 records

FDA root cause

  1. Process control · 67
  2. Software design · 18
  3. Employee error · 16
  4. Nonconforming Material/Component · 15
  5. Device Design · 9
  6. Labeling Change Control · 7
  7. Process design · 6
  8. Process change control · 6

Not yet classified (173)

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.