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Medical device recalls: July 2012

The FDA posted 178 medical device recall records in July 2012, from 108 recall events by 80 companies. 14 are Class I, the most serious category.

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. Terumo Cardiovascular Systems Corporation · 9 events, 28 records
  2. GE OEC Medical Systems, Inc · 6 events, 8 records, 4 Class I
  3. Stryker Howmedica Osteonics Corp. · 4 events, 5 records
  4. Philips Medical Systems (Cleveland) Inc · 4 events, 4 records
  5. GE Healthcare, LLC · 3 events, 3 records
  6. Exactech, Inc. · 2 events, 8 records
  7. PSC Industries Inc · 2 events, 8 records
  8. Alere San Diego, Inc. · 2 events, 6 records, 5 Class I

FDA root cause

  1. Device Design · 42
  2. Nonconforming Material/Component · 32
  3. Software design · 19
  4. Component design/selection · 11
  5. Process control · 10
  6. Labeling mix-ups · 10
  7. Labeling False and Misleading · 9
  8. Error in labeling · 8

Class I recalls (14)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (161)

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

Class III recalls (3)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.