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Medical device recalls: July 2006

The FDA posted 136 medical device recall records in July 2006, from 54 recall events by 44 companies. 136 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 · 3 events, 3 records
  2. Smith & Nephew, Inc. Endoscopy Division · 2 events, 8 records
  3. Kensey Nash Corp · 2 events, 4 records
  4. Terumo Cardiovascular Systems Corp · 2 events, 4 records
  5. Abbott Laboratories MPG · 2 events, 2 records
  6. Beckman Coulter Inc · 2 events, 2 records
  7. Boston Scientific Corp · 2 events, 2 records
  8. International Biophysics Corp · 2 events, 2 records

FDA root cause

  1. Other · 131
  2. Package design/selection · 2
  3. Device Design · 2
  4. Component change control · 1

Not yet classified (136)

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.