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Medical device recalls: May 2005

The FDA posted 64 medical device recall records in May 2005, from 39 recall events by 35 companies. 64 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. · 2 events, 2 records
  2. Hitachi Medical Systems America Inc · 2 events, 2 records
  3. Nichols Institute Diagnostics · 2 events, 2 records
  4. Siemens Medical Solutions USA, Inc · 2 events, 2 records
  5. Smiths Medical PM, Inc. · 1 event, 12 records
  6. Asahi Medical Co Ltd · 1 event, 5 records
  7. GE OEC Medical Systems,Inc · 1 event, 4 records
  8. Dunlee · 1 event, 3 records

FDA root cause

  1. Other · 60
  2. Software design · 1
  3. Process control · 1
  4. Employee error · 1
  5. Device Design · 1

Not yet classified (64)

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.