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Medical device recalls: January 2008

The FDA posted 190 medical device recall records in January 2008, from 69 recall events by 62 companies. 190 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. Ventana Medical Systems Inc · 3 events, 7 records
  2. Intuitive Surgical, Inc. · 3 events, 5 records
  3. Abbott Laboratories · 3 events, 3 records
  4. Biomet, Inc. · 2 events, 3 records
  5. Oasis Medical Inc · 1 event, 32 records
  6. Am2 Pat Inc · 1 event, 15 records
  7. Boston Scientific · 1 event, 11 records
  8. Argon Medical Devices, Inc · 1 event, 10 records

FDA root cause

  1. Device Design · 61
  2. Process design · 32
  3. Software design · 27
  4. Process control · 13
  5. Release of Material/Component prior to receiving test results · 12
  6. Labeling design · 9
  7. Nonconforming Material/Component · 8
  8. Labeling Change Control · 6

Not yet classified (190)

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.