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Medical device recalls: August 2007

The FDA posted 91 medical device recall records in August 2007, from 61 recall events by 48 companies. 91 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. Northwest Medical Physics Equipment Inc · 7 events, 7 records
  2. Sendx Medical Inc · 3 events, 3 records
  3. Abbott Diagnostic International, Ltd. · 2 events, 5 records
  4. Abbott Laboratories · 2 events, 5 records
  5. Boston Scientific Corporation · 2 events, 3 records
  6. Cardinal Health 303 Inc DBA Alaris Products · 2 events, 2 records
  7. Ross Products Division Abbott Laboratories · 2 events, 2 records
  8. Encore Medical, Lp · 1 event, 6 records

FDA root cause

  1. Other · 71
  2. Software design · 7
  3. Process control · 4
  4. Nonconforming Material/Component · 2
  5. Equipment maintenance · 2
  6. Device Design · 2
  7. Labeling mix-ups · 1
  8. Employee error · 1

Not yet classified (91)

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.