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Medical device recalls: August 2006

The FDA posted 172 medical device recall records in August 2006, from 70 recall events by 43 companies. 172 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. Radiometer America Inc · 16 events, 20 records
  2. Roche Diagnostics Corp. · 6 events, 32 records
  3. Zimmer Inc. · 3 events, 34 records
  4. Pointe Scientific, Inc. · 3 events, 24 records
  5. Beckman Coulter Inc · 3 events, 3 records
  6. Bayer Healthcare, LLC (Diagnostics Division) · 2 events, 4 records
  7. Cobe Cardiovascular, Inc · 1 event, 8 records
  8. Terumo Cardiovascular Systems Corp · 1 event, 3 records

FDA root cause

  1. Other · 165
  2. Software design · 4
  3. Process control · 1
  4. Packaging process control · 1
  5. Component design/selection · 1

Not yet classified (172)

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.