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Medical device recalls: February 2005

The FDA posted 110 medical device recall records in February 2005, from 35 recall events by 33 companies. 110 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. · 2 events, 30 records
  2. Smiths Medical ASD, Inc. · 2 events, 2 records
  3. Cook, Inc. · 1 event, 28 records
  4. Ethicon Endo-Surgery · 1 event, 6 records
  5. Lemaitre Vascular, Inc. · 1 event, 5 records
  6. Smiths Medical PM, Inc. · 1 event, 5 records
  7. Hu-Friedy Mfg Co, Inc. · 1 event, 4 records
  8. E-Z-EM, Inc · 1 event, 3 records

FDA root cause

  1. Other · 108
  2. Software design · 1
  3. Nonconforming Material/Component · 1

Not yet classified (110)

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.