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Medical device recalls: March 2007

The FDA posted 138 medical device recall records in March 2007, from 71 recall events by 61 companies. 138 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. Boston Scientific Corporation · 3 events, 15 records
  2. Abbott Laboratories · 3 events, 3 records
  3. Baxter Healthcare Corp. · 2 events, 7 records
  4. Terumo Cardiovascular Systems Corp · 2 events, 6 records
  5. Zimmer Inc. · 2 events, 6 records
  6. bioMerieux, Inc. · 2 events, 2 records
  7. Cook, Inc. · 2 events, 2 records
  8. Intuitive Surgical, Inc. · 2 events, 2 records

FDA root cause

  1. Other · 119
  2. Packaging process control · 13
  3. Software design · 3
  4. Process design · 1
  5. Nonconforming Material/Component · 1
  6. Device Design · 1

Not yet classified (138)

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.