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Medical device recalls: March 2010

The FDA posted 369 medical device recall records in March 2010, from 132 recall events by 100 companies. 369 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. Pointe Scientific, Inc. · 5 events, 16 records
  2. Toshiba American Medical Systems Inc · 5 events, 12 records
  3. Becton Dickinson & Co. · 5 events, 8 records
  4. Siemens Healthcare Diagnostics, Inc. · 4 events, 6 records
  5. Polymer Technology Systems, Inc. · 4 events, 4 records
  6. Stryker Howmedica Osteonics Corp. · 3 events, 5 records
  7. Elekta, Inc. · 3 events, 3 records
  8. Sybron Dental Specialties · 3 events, 3 records

FDA root cause

  1. Process control · 67
  2. Device Design · 61
  3. Nonconforming Material/Component · 44
  4. Other · 39
  5. Component design/selection · 38
  6. Labeling False and Misleading · 24
  7. Storage · 23
  8. Packaging process control · 16

Not yet classified (369)

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.