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Medical device recalls: November 2007

The FDA posted 126 medical device recall records in November 2007, from 52 recall events by 43 companies. 126 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 Healthcare · 4 events, 4 records
  2. Abbott Laboratories, Inc · 2 events, 3 records
  3. Toshiba American Med Sys Inc · 2 events, 3 records
  4. Edwards Lifesciences, Llc · 2 events, 2 records
  5. Electric Mobility Corp · 2 events, 2 records
  6. Philips Medical Systems (Cleveland) Inc · 2 events, 2 records
  7. Stryker Howmedica Osteonics Corp. · 2 events, 2 records
  8. Stryker Medical Div. of Stryker Corporation · 1 event, 21 records

FDA root cause

  1. Software design · 33
  2. Component change control · 23
  3. Packaging change control · 18
  4. Device Design · 14
  5. Process control · 9
  6. Packaging process control · 6
  7. Labeling design · 5
  8. Process design · 4

Not yet classified (126)

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.