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Medical device recalls: May 2012

The FDA posted 218 medical device recall records in May 2012, from 85 recall events by 66 companies. 218 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. Philips Medical Systems (Cleveland) Inc · 3 events, 6 records
  2. Siemens Healthcare Diagnostics, Inc. · 3 events, 5 records
  3. Siemens Medical Solutions USA, Inc. · 3 events, 5 records
  4. CaridianBCT, Inc. · 3 events, 3 records
  5. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  6. Stryker Howmedica Osteonics Corp. · 3 events, 3 records
  7. Zimmer Inc. · 2 events, 71 records
  8. ConMed Electrosurgery · 2 events, 5 records

FDA root cause

  1. Labeling design · 68
  2. Nonconforming Material/Component · 35
  3. Process design · 17
  4. Component change control · 16
  5. Device Design · 15
  6. Process control · 13
  7. Employee error · 9
  8. Equipment maintenance · 7

Not yet classified (218)

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.