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Medical device recalls: September 2009

The FDA posted 491 medical device recall records in September 2009, from 146 recall events by 110 companies. 491 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. GE Medical Systems, LLC · 10 events, 18 records
  2. Boston Scientific Corporation · 6 events, 12 records
  3. Philips Medical Systems North America Co. Phillips · 3 events, 20 records
  4. Abbott Laboratories · 3 events, 3 records
  5. Ebi, L.P. · 2 events, 38 records
  6. Ge Healthcare · 2 events, 6 records
  7. Medtronic Neuromodulation · 2 events, 5 records
  8. ConvaTec · 2 events, 4 records

FDA root cause

  1. Nonconforming Material/Component · 153
  2. Process control · 92
  3. Device Design · 47
  4. Packaging process control · 39
  5. Radiation Control for Health and Safety Act · 36
  6. Employee error · 26
  7. Software design · 24
  8. Mixed-up of materials/components · 14

Not yet classified (491)

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.