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Medical device recalls: February 2011

The FDA posted 458 medical device recall records in February 2011, from 101 recall events by 78 companies. 458 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 · 4 events, 19 records
  2. Elekta, Inc. · 4 events, 4 records
  3. Stryker Howmedica Osteonics Corp. · 3 events, 16 records
  4. Stryker Instruments Division of Stryker Corporation · 2 events, 32 records
  5. Centurion Medical Products · 2 events, 29 records
  6. Arrow International Inc · 2 events, 20 records
  7. Abbott Diabetes Care, Inc. · 2 events, 8 records
  8. Baxter Healthcare Corp. · 2 events, 5 records

FDA root cause

  1. Nonconforming Material/Component · 166
  2. Other · 127
  3. Software design · 33
  4. Process control · 33
  5. Device Design · 28
  6. Vendor change control · 16
  7. Packaging · 15
  8. Component design/selection · 9

Not yet classified (458)

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.