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Medical device recalls: November 2008

The FDA posted 138 medical device recall records in November 2008, from 46 recall events by 36 companies. 138 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 · 4 events, 29 records
  2. Terumo Cardiovascular Systems Corporation · 3 events, 6 records
  3. Animas Corporation · 2 events, 6 records
  4. Abbott Laboratories · 2 events, 2 records
  5. Advanced Sterilization Products · 2 events, 2 records
  6. Biomet Microfixation, Inc. · 2 events, 2 records
  7. Biomet, Inc. · 2 events, 2 records
  8. Kerr Corp · 1 event, 42 records

FDA root cause

  1. Component design/selection · 45
  2. Software design · 29
  3. Device Design · 17
  4. Nonconforming Material/Component · 15
  5. Process control · 8
  6. Other · 5
  7. Material/Component Contamination · 4
  8. Labeling mix-ups · 3

Not yet classified (138)

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.