Skip to content

Medical device recalls: February 2008

The FDA posted 226 medical device recall records in February 2008, from 58 recall events by 49 companies. 226 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. Medtronic Neuromodulation · 3 events, 18 records
  2. Stryker Howmedica Osteonics Corp. · 2 events, 20 records
  3. Siemens Medical Solutions USA, Inc · 2 events, 14 records
  4. Advanced Sterilization Products · 2 events, 5 records
  5. Smiths Medical MD, Inc. · 2 events, 5 records
  6. Intuitive Surgical, Inc. · 2 events, 3 records
  7. Varian Medical Systems Inc · 2 events, 3 records
  8. Siemens Medical Solutions USA, Inc · 2 events, 2 records

FDA root cause

  1. Process control · 98
  2. Device Design · 39
  3. Process design · 15
  4. Packaging process control · 14
  5. Other · 13
  6. Software design · 10
  7. Nonconforming Material/Component · 8
  8. Mixed-up of materials/components · 7

Not yet classified (226)

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.