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Medical device recalls: March 2012

The FDA posted 224 medical device recall records in March 2012, from 111 recall events by 82 companies. 224 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, 11 records
  2. Philips Healthcare Inc. · 5 events, 5 records
  3. Biomet, Inc. · 3 events, 9 records
  4. Integra LifeSciences Corp. · 3 events, 3 records
  5. Ormco Corporation · 3 events, 3 records
  6. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records
  7. Varian Medical Systems, Inc. Oncology Systems · 3 events, 3 records
  8. Terumo Cardiovascular Systems Corporation · 2 events, 30 records

FDA root cause

  1. Nonconforming Material/Component · 73
  2. Packaging · 24
  3. Device Design · 24
  4. Process control · 19
  5. Software design · 17
  6. Mixed-up of materials/components · 13
  7. Packaging process control · 10
  8. Process design · 6

Not yet classified (224)

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.