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Medical device recalls: February 2012

The FDA posted 193 medical device recall records in February 2012, from 110 recall events by 84 companies. 193 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, LLC · 7 events, 8 records
  2. Philips Medical Systems (Cleveland) Inc · 5 events, 5 records
  3. Ortho-Clinical Diagnostics · 4 events, 5 records
  4. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  5. Sybron Dental Specialties · 2 events, 6 records
  6. Angiodynamics Worldwide Headquarters · 2 events, 5 records
  7. Leica Microsystems, Inc. · 2 events, 4 records
  8. Alere San Diego · 2 events, 3 records

FDA root cause

  1. Nonconforming Material/Component · 37
  2. Device Design · 25
  3. Packaging process control · 22
  4. Software design · 21
  5. Packaging · 18
  6. Under Investigation by firm · 13
  7. Labeling mix-ups · 11
  8. Process control · 7

Not yet classified (193)

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.