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Medical device recalls: August 2005

The FDA posted 397 medical device recall records in August 2005, from 68 recall events by 52 companies. 397 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. Baxter Healthcare Corp. · 6 events, 28 records
  2. Beckman Coulter Inc · 4 events, 4 records
  3. Roche Diagnostics Corp. · 3 events, 3 records
  4. Guidant Corporation · 2 events, 5 records
  5. Baxter Healthcare Renal Div · 2 events, 3 records
  6. Abbott Laboratories MPG · 2 events, 2 records
  7. Becton Dickinson & Company · 2 events, 2 records
  8. Boston Scientific Corp · 2 events, 2 records

FDA root cause

  1. Other · 392
  2. Device Design · 4
  3. Process change control · 1

Not yet classified (397)

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.