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Medical device recalls: August 2008

The FDA posted 208 medical device recall records in August 2008, from 97 recall events by 77 companies. 208 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. Smiths Medical MD, Inc. · 3 events, 4 records
  2. Stryker Howmedica Osteonics Corp. · 3 events, 4 records
  3. Acumed LLC · 3 events, 3 records
  4. Beckman Coulter Inc · 3 events, 3 records
  5. Boston Scientific Corporation · 3 events, 3 records
  6. Advanced Sterilization Products · 2 events, 7 records
  7. Stryker Endoscopy · 2 events, 7 records
  8. Genzyme Corporation · 2 events, 6 records

FDA root cause

  1. Software design · 52
  2. Nonconforming Material/Component · 40
  3. Device Design · 38
  4. Component design/selection · 12
  5. Process control · 11
  6. Other · 8
  7. Employee error · 7
  8. Process change control · 6

Not yet classified (208)

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.