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Medical device recalls: March 2011

The FDA posted 405 medical device recall records in March 2011, from 148 recall events by 94 companies. 405 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. · 6 events, 7 records
  2. Bio-Rad Laboratories Inc · 6 events, 7 records
  3. Biomet, Inc. · 5 events, 32 records
  4. Abbott Laboratories · 5 events, 9 records
  5. GE Healthcare, LLC · 5 events, 6 records
  6. Depuy Orthopaedics, Inc. · 4 events, 84 records
  7. Philips Medical Systems North America Co. Phillips · 4 events, 10 records
  8. Elekta, Inc. · 4 events, 4 records

FDA root cause

  1. Device Design · 112
  2. Other · 93
  3. Process control · 33
  4. Nonconforming Material/Component · 31
  5. Process design · 28
  6. PMA · 23
  7. Software design · 17
  8. Pending · 11

Not yet classified (405)

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.