Skip to content

Medical device recalls: January 2006

The FDA posted 117 medical device recall records in January 2006, from 72 recall events by 58 companies. 117 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. Roche Diagnostics Corp. · 3 events, 15 records
  2. Baxter Healthcare Corp. · 3 events, 4 records
  3. Becton Dickinson & Co. · 3 events, 3 records
  4. Boston Scientific Corporation · 2 events, 6 records
  5. Becton Dickinson & Company · 2 events, 5 records
  6. Smiths Medical ASD, Inc. · 2 events, 4 records
  7. Boston Scientific Scimed · 2 events, 3 records
  8. Cook, Inc. · 2 events, 3 records

FDA root cause

  1. Other · 112
  2. Device Design · 2
  3. Software design · 1
  4. Software change control · 1
  5. Process control · 1

Not yet classified (117)

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.