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Medical device recalls: July 2007

The FDA posted 143 medical device recall records in July 2007, from 61 recall events by 51 companies. 143 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. Abbott Diagnostic International, Ltd. · 4 events, 9 records
  2. Terumo Cardiovascular Systems Corp · 2 events, 16 records
  3. Baxter Healthcare Corp. · 2 events, 5 records
  4. Radiometer America Inc · 2 events, 3 records
  5. Diagnostica Stago, Inc. · 2 events, 2 records
  6. Medtronic Perfusion Systems · 2 events, 2 records
  7. Smiths Medical PM, Inc. · 2 events, 2 records
  8. Thoratec Corp · 2 events, 2 records

FDA root cause

  1. Other · 123
  2. Device Design · 8
  3. Software design · 5
  4. Nonconforming Material/Component · 2
  5. Labeling design · 2
  6. Component design/selection · 2
  7. Process control · 1

Not yet classified (143)

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.