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Medical device recalls: January 2012

The FDA posted 570 medical device recall records in January 2012, from 204 recall events by 133 companies. 560 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. Angiodynamics Worldwide Headquarters · 7 events, 71 records
  2. Varian Medical Systems, Inc. Oncology Systems · 7 events, 9 records
  3. Siemens Medical Solutions USA, Inc · 7 events, 7 records
  4. ConMed Corporation · 4 events, 17 records
  5. Biomet Microfixation, Inc. · 4 events, 6 records
  6. Philips Medical Systems (Cleveland) Inc · 4 events, 6 records
  7. GE Healthcare, LLC · 4 events, 5 records
  8. Ortho-Clinical Diagnostics · 4 events, 5 records

FDA root cause

  1. Nonconforming Material/Component · 131
  2. Device Design · 94
  3. Material/Component Contamination · 66
  4. Component design/selection · 39
  5. Employee error · 32
  6. Process control · 31
  7. Software design · 25
  8. Reprocessing Controls · 21

Class II recalls (10)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Not yet classified (560)

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.