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Medical device recalls: February 2007

The FDA posted 122 medical device recall records in February 2007, from 57 recall events by 48 companies. 122 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. Terumo Cardiovascular Systems Corp · 8 events, 16 records
  2. USA Instruments Incorporated · 2 events, 5 records
  3. Beckman Coulter Inc · 2 events, 4 records
  4. Skytron, Div. The KMW Group, Inc · 1 event, 11 records
  5. Becton Dickinson and Company · 1 event, 10 records
  6. Boston Scientific · 1 event, 7 records
  7. Candela Laser Corporation · 1 event, 6 records
  8. Biosense Webster, Inc. · 1 event, 5 records

FDA root cause

  1. Other · 120
  2. Software design · 1
  3. Process design · 1

Not yet classified (122)

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.