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Medical device recalls: July 2004

The FDA posted 870 medical device recall records in July 2004, from 346 recall events by 217 companies. 870 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. Beckman Coulter Inc · 26 events, 29 records
  2. Roche Diagnostics Corp. · 9 events, 31 records
  3. Abbott Laboratories HPD/ADD/GPRD · 9 events, 23 records
  4. Cryolife Inc · 8 events, 16 records
  5. Boston Scientific Corporation · 5 events, 9 records
  6. Philips Medical Systems Sales & Service Region No. America · 5 events, 6 records
  7. Abbott Laboratories, Inc · 5 events, 5 records
  8. Toshiba American Med Sys Inc · 5 events, 5 records

FDA root cause

  1. Other · 859
  2. Nonconforming Material/Component · 5
  3. Software design · 2
  4. Labeling mix-ups · 2
  5. Process control · 1
  6. Component design/selection · 1

Not yet classified (870)

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.