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Medical device recalls: August 2012

The FDA posted 186 medical device recall records in August 2012, from 128 recall events by 81 companies. 17 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. GE OEC Medical Systems, Inc · 8 events, 10 records, 2 Class I
  2. Siemens Healthcare Diagnostics, Inc. · 7 events, 7 records
  3. Sunquest Information Systems, Inc. · 5 events, 5 records
  4. Abbott Point Of Care Inc. · 4 events, 6 records
  5. Philips Healthcare Inc. · 4 events, 4 records
  6. Terumo Cardiovascular Systems Corporation · 3 events, 7 records
  7. Beckman Coulter Inc. · 3 events, 6 records
  8. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records

FDA root cause

  1. Device Design · 37
  2. Process control · 33
  3. Software design · 32
  4. Nonconforming Material/Component · 22
  5. Labeling mix-ups · 9
  6. Component design/selection · 7
  7. Process design · 5
  8. PMA · 5

Class I recalls (17)

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

Class II recalls (153)

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

Class III recalls (16)

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.