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Medical device recalls: April 2006

The FDA posted 125 medical device recall records in April 2006, from 46 recall events by 40 companies. 125 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. Siemens Medical Solutions USA, Inc · 3 events, 6 records
  2. Baxter Healthcare Corp. · 2 events, 5 records
  3. AGFA Corp. · 2 events, 4 records
  4. Smiths Medical ASD, Inc. · 2 events, 3 records
  5. Medex Inc · 2 events, 2 records
  6. Medtronic Sofamor Danek Instrument Manufacturing · 1 event, 35 records
  7. Alpha Omega Services Inc · 1 event, 8 records
  8. Apple Medical Corporation · 1 event, 8 records

FDA root cause

  1. Other · 121
  2. Nonconforming Material/Component · 2
  3. Process control · 1
  4. Device Design · 1

Not yet classified (125)

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.