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Medical device recalls: May 2006

The FDA posted 103 medical device recall records in May 2006, from 57 recall events by 52 companies. 103 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. Guidant Corporation · 3 events, 8 records
  2. Beckman Coulter Inc · 2 events, 4 records
  3. GE Healthcare · 2 events, 4 records
  4. Ev3, Inc · 2 events, 2 records
  5. Dade Behring , Inc. · 1 event, 12 records
  6. Ethicon Endo-Surgery Inc · 1 event, 12 records
  7. Kimberly-Clark Corporation · 1 event, 6 records
  8. Bard Access Systems, Inc · 1 event, 4 records

FDA root cause

  1. Other · 85
  2. Packaging process control · 12
  3. Error in labeling · 4
  4. Process control · 1
  5. Labeling False and Misleading · 1

Not yet classified (103)

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.